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Blog
Mar 08, 2021
International Women’s Day is not just a Women’s Issue. It’s a Business Issue.
Teckro is leading the way with our company-wide commitment to gender diversity. Before putting pen to paper to write this article about International Women’s Day, I debated whether I should be writing it at all. Shouldn’t I ask one of the many talented women who work for Teckro to write it instead, I wondered. But as CEO of Teckro, I felt it my duty to highlight some of the company’s achievements when it comes to employing and promoting women. After all, human nature being what it is, we tend to look to others to see what we should be doing. And companies are made up of humans who make important decisions every day. So, if I could inspire other leaders to commit to taking bold steps towards leveling the playing field in terms of gender diversity in their companies, I should write the article, I thought. When you’re running a company, you want the best people on your team. Gender or any other discriminatory factors shouldn’t come into it. But we don’t live in an ideal world and it can be hard to overcome internal biases. I’d like to emphasize that Teckro doesn’t promote women just because they’re women. We promote people fairly regardless of their gender – and this is the point. When companies do leave their biases at the door and assess individuals on merit, more women will naturally rise to the top. Let’s have a look at some figures that show how Teckro is leading the way in terms of male to female ratios both cross-company and on our leadership teams: Company-wide: 51% female, 49% male Senior Management Team: 56% female, 44% male Executive Team: 36% female, 63% male  Management across the company (all levels): 50% female, 50% male More Work to be Done While women at Teckro can rely on being paid equally to men and receiving equal opportunities for employment and promotion, the reality is that for millions of women across the world this is not the case. According to the United Nations: In all countries, women are paid less than men, with the gender pay gap estimated at 23%. Women earn 77 cents for every dollar men earn for work of equal value and there is an even wider wage gap for women with children. If the trend keeps going in this direction, it will take the next 257 years to close the global gender pay gap. A couple of years ago, there were more men called David and Steve leading FTSE companies than women or ethnic minorities. But in February this year, a UK government review found that the number of women on the boards of top UK-listed companies has risen by 50% in five years - making all-men FTSE boards “extinct.” But despite these promising figures, the report showed that women are still underrepresented in the highest leadership positions. To me, this demonstrates that we need to have more conversations about how to address gender gaps. It’s also important to remember that women don’t suffer discrimination just in the workplace. As we’ve written about in our blog a year ago on this very day, women’s participation in clinical trials is too low, with the male to female ratio for many disease types still not matching the real-world gender split. And women are 50% more likely to be misdiagnosed after a heart attack because they can experience symptoms differently – and most people don’t know this. Adding More Voices to the Conversation Just as we at Teckro contribute to the conversations about advancing diversity in clinical trials, we also have a part to play in the broader business world. To that point, I’m pleased to introduce a new Teckro podcast series called Women in Leadership. Our team has taken the opportunity to interview a group of accomplished professional women to give them a platform to share their thoughts about how we can address diversity at the top levels, as well as positive stories about progress made to date. For example, we hear from Elisabeth Baugh, CEO of Ovarian Cancer Canada about the importance of mentors and on-the-job training for women throughout their careers. Then there’s Sabrina Martucci Johnson, CEO of Daré Bioscience who shares her vision for a more equitable balance when it comes to leadership and other influential roles. And pharmaceutical executive Dairine Dempsey, explains how women often start off well at entry and mid-levels, but too frequently encounter obstacles at the higher echelons of leadership. You can hear the full podcast here. International Women’s Day is not just a Women’s Issue Diversity isn’t just a good thing because it’s “fair” to women and other underrepresented groups. Diversity is something that’s desirable because it creates a stronger organization for all stakeholders. It leads to more creativity and better outcomes for businesses. Different groups think and perceive the world differently. Bringing these perspectives to the business world is crucial to grow and develop into better organizations – with improved decision-making, risk-taking, and work environments. So this International Women’s Day, I encourage businesses everywhere to make gender diversity one of their priorities. Teckro has gone from strength to strength since our inception five years ago, and I believe that this is strongly linked to our commitment to hiring the most talented people for the job. After all, people are one of the most precious resources for any company.
Blog
Feb 04, 2021
World Cancer Day 2021: There’s No Going Back
On World Cancer Day last year I wrote about the progress we’ve made as a society in the fight against cancer. I highlighted the importance of modernizing the clinical trials process so drugs can get to market faster and called for more action towards simplifying trials, making them fit for the 21st Century. What a difference a year makes! Who would have predicted that a month later the Western world would lockdown as COVID-19 swept the globe? Or that 12 months on I would be writing this from my home office, with no clear timetable for when I will return to my office in Limerick. It’s certainly been a challenging year. As a team we’ve really pulled together to make remote working a success. And Teckro is playing our own part in the fight against the pandemic, supporting trials to discover new drug treatments. As well, Teckro’s technology continues to support oncology trials. In fact, seven out of the top 20 pharmaceutical companies rely on our technology for their cancer studies, along with as several biotechnology companies.
Blog
Jan 14, 2021
Looking Forward to 2021 and Beyond: Four Reasons to be Optimistic for the Clinical Trials Industry
2020 was a difficult year - to put it mildly! If you had told me this time last year that our lives would be so thoroughly disrupted, with work, schools and social lives all moving online, I would have found it hard to believe. The novel coronavirus, COVID-19, has changed everything so dramatically and we have not yet come out of the other side of the chaos. But despite the gloom, there is much to be hopeful for in 2021 and beyond. The world’s most talented scientists collaborated to develop vaccines at record speed. Science and technology have shown us what is truly possible. I am proud to be part of the clinical trials industry that has helped facilitate this incredible story of human ingenuity. The Spotlight on Clinical Trials As a result of the disruption, the world is keenly focusing on clinical trials. Those working in the industry are not used to the limelight. They work hard quietly in the background to keep trials running so drugs can get to market and lives can be saved. But in the last year, clinical trials have gone from being an abstract idea of how drugs are developed, to a key factor in how people can protect themselves, their families and get back to normal life. And what we have seen has been extraordinary. The Pfizer-BioNTech vaccine, first fast-tracked for emergency use in the UK in early December and followed swiftly by the US and Europe, represents a breakthrough scientific achievement to fight this devastating pandemic. The Moderna vaccine, which uses the same mRNA technology as the Pfizer vaccine, has been approved in the US and the EU. As well as this, the Oxford-AstraZeneca vaccine is being rolled out in the UK as I speak, with the first person vaccinated in the first week of this year. I am optimistic that the situation will look different by summer 2021 and that what we have learned as an industry from COVID-19 will have positive consequences for society. The Power of Humans In 2020 we have seen how successfully the human race can work effectively together to accomplish big goals for humanity. Goals that previously didn’t seem possible. From vaccine researchers, to the amazing medical staff on the ground, everyone has played their role. Here at Teckro we also did our bit supporting drug trials to help find treatments for COVID-19. And we will continue in our mission to help the world recover from this difficult period by supporting clinical trials success. So, there is much to be thankful for and much to look forward to. Here are four reasons to be optimistic for the clinical trials industry in 2021 and beyond: 1. COVID-19 has proved that vaccines can be developed at record speed Initially, scientists were careful not to promise quick results when it came to developing a vaccine. There was much speculation around the idea of a vaccine being discovered so fast – in an industry where the process is complicated and safety is paramount. Vaccines have eradicated many deadly illnesses throughout history, from mumps to smallpox and polio, and have greatly increased the average life expectancy. Prior to COVID-19, the fastest a vaccine had ever been developed from early sampling to approval was four years – the mumps vaccine in the early 1960s. In contrast, an AIDS vaccine is still not available after 30-plus years of effort. Luckily, history was made. The world collectively breathed a sigh of relief. The news of the Pfizer-BioNTech vaccine was announced early November. The vaccine took just 10 months to follow the same steps that normally take 10 years. But this achievement goes beyond COVID-19. The fact that a vaccine has been developed at record speed, bodes well for the future of vaccines, drugs and treatments. I predict we will see profound cultural and practical changes in the way companies approach the clinical trials process and what they deem possible. This has the potential to save many more lives across the globe. 2. Clinical trials will make greater use of technology to get studies back on track When the pandemic hit, many clinical trials were forced to stop. Some trials were too complicated to continue without the physical presence of patients and staff such as oncology trials. But other trials were able to continue by adapting to new ways of working. Sponsors moved at hyper speed to make the most of solutions such as decentralized trials, wearable technologies and real-time communications technology. The pharmaceutical industry has been slow to adapt to the modern age, but COVID-19 has sped the process up. This lag of uptake happened despite the modernization of ICH Good Clinical Practice (GCP), with the introduction of ICH E6 (R2) which required sponsors and CROs to implement a more robust risk management process. The aim was to make sure clinical teams applied critical thinking lessons learned from previous trials. The technology was available to enable this approach, but full industry adoption was still too slow. Now it seems that pharmaceutical and biotech companies have discovered what many other industries already knew - that there are huge advantages to utilizing technology – which can be used to optimize clinical trials, leading to greater safety, efficiency and data integrity. I am optimistic we will see companies continue to adopt new solutions at pace in 2021 and beyond – and it’s about time, too. 3. Technology means we will see greater diversity Statistics show that ethnic populations in the US made up of Blacks, Asians and Latinos, represented just a quarter of trial participants over 10 years. This urgently needs to change and technology can help by bringing communities closer together. As discussed above, the rapid uptake of technology will lead to smoother relationships between stakeholders working in the clinical trials industry as communication and efficiency are improved. The same can happen in local communities. Strengthening connections between participants, community HCPs and research sites on the ground can improve diversity by building trust with underrepresented groups. And solutions such as decentralized trials can make it easier for them to access trials, as they won’t have to travel, or lose out on work. Ironically, technology can help to “humanize” the clinical trials process, with stronger ties at a local level helping to bridge the gap between ethnic minorities and clinical trials.   4. There will be greater data transparency in the clinical trials process COVID-19 has shown the necessity for data transparency when it comes to expediting the drug development process. Regulators need data to make informed decisions about which treatments and drugs they will approve and why. Decisions need to be made that are supported by the data, which should be available to healthcare professionals and the general public. This may sound obvious, but access to the right information increases trust – which is crucial to ensure uptake of vaccines and treatments to fight the pandemic. Research in 2020 showed that sponsor organizations continue to miss reporting deadlines for publishing results within one year after a study has finished. This lack of openness must and will change. After all, COVID-19 has changed the game, with the European Medicine Agency (EMA) deciding to publish clinical data for COVID-19 medicines, such as the authorization of Veklury (remdesivir). The EMA will also publish information on the COVID-19 treatments and vaccines that have received scientific advice or official guidance from its pandemic task force. Data visibility needs to be built into the entire process of clinical trials, not just the reporting of completed trials. This is why we founded Teckro, clinical research should be simpler and easy to access. Today, data openness is no longer a nice-to-have, but a must-have and I predict that the pandemic will kickstart a new trend with greater data transparency. This means that the whole research community as well as the public can remain involved and informed when new drugs, treatments and vaccines are developed and approved. Our Mission in 2021 and Beyond Teckro came into existence in 2015. Five years connecting all clinical study stakeholders with the answers they need and of working hard together to achieve our goals. Like everyone else, we have had to adapt to new working practices this year to ensure we all remain safe and secure. It has been a huge learning curve for us, with our team emerging stronger than ever. For this, I am incredibly proud. Our purpose to modernize clinical trials is now needed more than ever. The situation is urgent and while the industry has adapted successfully during the pandemic, the challenge is to continue this in the future. The good news is that we have seen the best of humanity working together to find a solution to the chaos unleashed on the world and the industry has made huge leaps forward. The future is bright and moving into 2021 and beyond I am optimistic that the clinical trials industry will be transformed and fit for the modern era. Here at Teckro, our mission is to support clinical trials stakeholders across the board and to save more lives by speeding up drug development. I have faith we will succeed and am looking forward to the year ahead – it will be a good one!  
Blog
Nov 18, 2020
Introducing Teckro Connect: Clinical Trial Communication in the Hands of Research Staff
There is a gap in clinical trial communication. In fact, it is a chasm separating those conducting research and those with study expertise.   Considering how hard it is to execute clinical trials today, logic would say that sponsors and CROs should do everything in their power to make it as easy as possible for research staff to ask questions or clarify their interpretation of protocol instruction. But until now it’s been hard work for investigators and site staff to get in touch with study experts. Depending on the urgency, they may call, email or use some other non-compliant communication app to reach their main point of contact, often a study monitor. This then kicks off either a game of telephone or an email loop, neither of which are designed for expedited answers. The Game of Telephone If you’ve ever played the “game of telephone” as a team building exercise, it is interesting how the fidelity of the message degrades as it passes from person to person. What it shows is the farther away from the source, the less accurately information is conveyed. Generally, it isn’t something malicious – it’s just the nature of how communication flows. For example, if you have limited knowledge on the subject, you may not be equipped to completely and accurately relay the information. Or you might be distracted during the conversation so that you may not capture the entire story.  In turn, what you convey downstream is not quite complete. Caught in the Email Loop Email is better served as a channel to inform than it is to resolve time sensitive queries.  Depending on the number of forwards and how long it takes for the information to make its way along a chain of people, it could be too late or even outdated by the time it reaches the intended recipient. Additionally, email can be open to misinterpretation. For example, we may be unintentionally biased in reading what we think the email says, instead of what it actually says. This could lead to a mismatch of the answer sent back that is not actually to the original question. And If further clarification is needed, the whole email thread kicks off again. Introducing Teckro Connect When we look at clinical trials, particularly when physicians and research staff need time sensitive answers, the way communication is handled today is akin to the game of telephone or the email loop. Simply put: neither are fit for purpose.    That is why we are introducing Teckro Connect. Teckro Connect puts the power directly in the hands of research site staff to ask questions of study experts. It sits within our digital engagement suite, so the user can switch from a keyword search to requesting medical advice – all within Teckro. And it is compliant with industry regulations, including 21 CFR Part 11. Let’s take the example of a doctor who is with a participant and needs an immediate answer related to dose modification. I’ll contrast the “old way” and the new way with Teckro Connect.
Blog
Nov 10, 2020
Why Clinical Trial Data Transparency is Critical in the Age of COVID-19
At the heart of it, clinical trials are about data. By testing treatments and drugs, researchers seek to measure how well they work and quantify possible side effects. Regulators need data to make informed decisions about which treatments and drugs they will approve – and for what specific indications. As we are all acutely aware, researchers around the world are working on COVID-19 treatments to lessen the severity if you get the virus and vaccines to put an end to the pandemic. In this extraordinary time, everyone is trying to move quickly. But even if time is of the essence, we need to balance safety with speed. There’s just too much at stake to rush decisions that aren’t supported by data. And the data should be transparent so healthcare professionals and the public in general have access.   At the risk of stating the obvious: clinical trial data needs to be made available sooner rather than later. In a positive step for data transparency, the European Medicine Agency (EMA) decided to publish clinical data for COVID-19 medicines. The first results published were the data that supported the authorization of Veklury (remdesivir). EMA will also publish information on the COVID-19 treatments and vaccines that have received scientific advice or official guidance from its pandemic task force.   Data sharing means that the whole research community can be involved. This can be especially useful when pandemics occur. For example, during the Ebola epidemic six years ago, data sharing meant that the virus was rapidly able to be controlled. Additionally, research duplication can be reduced when resources are pooled through data sharing. Expectations for Publishing Clinical Trial Results As it stands, FDA rules require clinical trial sponsors to post results to Clinicaltrials.gov one year after a study has finished. Yet, research earlier this year from Science shows that sponsor organizations continue to miss the reporting deadline. Some have downplayed concerns about missing deadlines for ClinicalTrials.gov, saying that instead researchers, doctors, and patients can learn about trial outcomes from peer-reviewed publications. But the reality is that thousands of trials are never published, particularly when treatments are found not to be effective. Over the last few years, we have seen efforts to tackle the missing data. For example in 2013, The BMJ announced that it would “no longer publish any trial of drugs or devices where the authors did not commit to making the relevant anonymized patient level data available, on reasonable request.” And in February 2020, hundreds of universities, drug companies and medical device manufacturers were ordered by a federal judge in New York to post missing trial data for trials conducted on drugs and devices over the last 10 years. Building Transparency into Clinical Trial Process Maybe it sounds ambitious to expect reported results for all clinical trials. But as we are seeing backlashes now from people who either don’t want to participant in COVID-19 clinical trials or are already gearing up to reject a vaccine – it is critically important that clinical trial findings are transparent. But if we look at the way trials are run today, there are so many parts where data transparency just isn’t there. We need to look at building data visibility into the entire process of clinical trials – not just the reporting of completed trials. This is why we founded Teckro: on the belief that clinical research must be simpler, more accessible and transparent. In the current climate, data openness is no longer a “nice-to-have” but a “must-have.” During the clinical trial process, our technology ensures that there’s full transparency for all stakeholders – from sponsors, to monitors, to physicians and research staff. In the end, everyone benefits if they have greater insight and visibility into study activity. What I’m talking about is bigger than simply the “traditional” clinical trial data that is documented with each patient and each visit. I’m talking about the data – the visibility – into the trial itself. This ranges from what sites are engaged with the protocol to what kind of questions research staff have about specifics in the protocol. You may not think of questions as data. But the reality is that each site question contributes to a pool of questions. And what if the sponsor could identify a pattern that multiple sites are looking for information because of an adverse event, say a skin reaction. Taken together, these individual questions form a pattern that can be an early indicator of a potential safety risk.  This transparency just isn’t possible when the protocol is a static paper document.   Not only does this greatly improve the relationship between physicians and sponsors – ensuring more confidence and honesty – it also can make trials safer and more efficient. Fewer protocol deviations mean better trial quality. And greater data transparency speeds up the drug-to-market timeline. Everyone benefits. Building Good Faith with Patients and Doctors Over the next few years clinical trial transparency needs to be an urgent focus for both governments and the wider industry. The pandemic demonstrates that it is of the utmost importance that public health institutions can act at speed during times of crisis.  As well as this, the public needs to feel they can have faith in the clinical trial process. With data transparency, patients and doctors are more confident because they can see the results for themselves. For those patients participating in research, it is important that they know that the data they helped contribute to is made widely available. The pandemic is pushing the industry to change on several levels. Greater transparency and a more modern approach to clinical trials are good for everyone. Once we are past COVID-19, these changes will hopefully be entrenched and there’s no going back.
Blog
Sep 22, 2020
Getting Oncology Clinical Trials Back on Track after COVID-19
The COVID-19 pandemic has caused enormous disruptions to clinical trials across the world. It is estimated that around 80% of non-COVID trials have been stopped or interrupted due to concerns about patient safety. Vulnerable populations who participate in trials are most affected by the virus, so it makes sense that many of these trials have not gotten back to normal – even as restrictions ease. At the same time, the devastating effect that this closure has had on medical research cannot be ignored. In the UK more than 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed. As well as this, 9,000 have been suspended and most will need large cash injections to be reactivated. That this is a problem cannot be stated enough – especially when it comes to oncology trials. According to the World Health Organization, cancer deaths are the second leading cause of death globally and the disease was responsible for an estimated 9.6 million deaths in 2018. As well as this, oncology trials typically have a low success rate and longer recruitment times due to stringent patient inclusion criteria and cannot afford to be further delayed. While there is some good news - globally more than a third of oncology trials have now started up again. As a society, we must not get off-track after we have come so far in the fight against cancer. It is understandable that talk of “back to normal” may seem premature to some - but the last few months have seen a tremendous uptake of new technologies by sponsors and site staff to keep clinical trials functioning where possible. For the clinical trials industry, this is not “normal.” It is revolutionary and all of us in the industry should do our best to ensure that this change in trial management process paves the way for as many trials as possible to get (safely and quickly) up and running again. Technology is the way forward Trials that were stopped, in many cases were stopped from enrolling new patients. But where they could, sponsors moved at hyper speed in their adoption of solutions such as decentralized trials, wearables and real-time communication technologies. The usually conservative pharmaceutical industry has demonstrated that it can move fast when necessary. The genie is out of the bottle about the amazing opportunity the industry has to completely rethink the future management of trials. Picture a world where trials were run at maximum efficiency and drugs got to market much faster. Where the diversity problem could finally be addressed, as neglected and underrepresented groups could have more flexibility, addressing the gender and ethnic minority gap. And we would know that during times of global crisis and chaos (such as another pandemic) clinical trials could keep going. The new habits that the industry would have to adopt is a small price to pay for this peace of mind. Patient enrollment and oncology trials Patient enrollment is one key area where technology could have a huge impact on speed and efficiency. As mentioned above, inclusion criteria are especially strict for oncology trials. Many studies have exclusions based on whether patients have had chemotherapy, have an advanced stage of the disease or have not recently been diagnosed. In fact, according to figures from the National Center for Biotechnology Information, 16% of protocol amendments are due to changes in inclusion/exclusion criteria. Oncology trials also have lower completion rates across all phases. Analysis of clinical trial data from 2000 to 2015 by Oxford Academic, showed that just 73.9% of the trials reached completion, with the median duration for oncology rates 13.1 years in comparison to 5.9 to 7.2 years for non-oncology trials. Typically, oncology trials have a lower approval rate as well, which, according to Oxford Academic, could be as low as 3.4%. And FDA approval in the United States currently has a 97% failure rate, generally due to issues with drug efficacy or toxicity. Treatments can be also very targeted, based on specific genetic markers, making it much harder to find suitable patients in comparison to non-oncology trials. This is where biomarkers can help. Biomarkers predict responses to oncology drugs, so if patients can be screened for the biomarker before enrolment, then there is a much higher chance that the patient will respond to the treatment. Additionally, by expanding the pool of research sites and investigators, this too can help with patient enrollment. As we’ve written in many of our blogs, by working with more novel research sites, the standard of care with clinical trials can be available to those who otherwise may be left behind because of socioeconomic factors, geography, or general lack of access to clinical trials. Technology to make the conduct of clinical trials simpler will go a long way in expanding the number and the diversity of investigators and research sites. Ticking time bomb of cancer delays The complexity of oncology clinical trials means that technology can be especially useful when it comes to speeding up patient enrollment. Rather than having to constantly seek out the protocol to confirm eligibility, typically tucked away in a paper format or on a portal on a desktop computer somewhere, real-time access like what we can provide with Teckro allows physicians and research staff get immediate answers from their digital device right then and there. This is saving precious time and also improving the decision-making process of which participants to enroll into a given study. As oncology trials take longer and have a low success rate, any further delays in clinical trials will be devastating for millions of people worldwide over the next few years. There is already a huge cancer care backlog with millions of patients around the world facing delays in diagnosis and treatment. It is imperative that we learn valuable lessons from the pandemic so we can keep trials – especially oncology trials – running during future emergencies. We cannot forsake clinical trials every time there is a global pandemic - there is too much at stake.
Blog
Jul 22, 2020
5 Years of Teckro: We’ve Come a Long Way, But We’re Just Getting Started
I’ve often heard people describe starting a new company as being so hard and the challenges so great, that it is something you really have to love to persevere and succeed. Everything is stacked against you – if you considered the odds, you would never start a company. It reminds me of an article penned by the late actor Richard Harris when he wrote, “How do you explain a love affair? It belongs to the heart, not the head, something to be embraced or spurned – there can be no middle ground.” As entrepreneurs, we accept the challenge and dive head-first in. When we started Teckro, we had a bit of an advantage in that it was our second technology start-up. The first company, Firecrest Clinical, beat the odds as we successfully operated for a decade. Then, ICON acquired the company in 2011, and we stayed on as part of the ICON leadership for a couple of years. I can’t say we started Firecrest with a master plan or that it was intentionally the goal to sell the company to a CRO. But that experience as part of a global CRO gave me a deeper appreciation for just how broken the clinical trial process really was. There had to be a better way – a challenge we whole-heartedly embraced. Balancing Optimism with Uncertainty   There needs to be a degree of optimism to start a new company. In starting Teckro, we believed in a better way for clinical research so that drugs could come to market safer, faster, and more efficiently. At the same time, there is also a degree of uncertainty in getting a new company off the ground. Some of the factors are relatively within your control, such as designing your management team, hiring your first employees, and building your first product. Yet, the pandemic of 2020 – which isn’t something any of us would have thought of in 2015 – brings a new level of uncertainty. Whether a global health crisis or economic downturns, start-ups need a solid foundation to weather these storms. If there is anything certain for entrepreneurs, it is that these storms will come. It is how you prepare that matters. Any company starting out needs to have a purpose and then justify to prospective customers, investors, employees and the market in general why you exist. It’s finding that business problem and then delivering a product or service to solve the issue. It’s painting a vision that others buy into about what the future could be like if there were a different way of doing things. For us, it was a vision that clinical trials needed to be simpler, more accessible and transparent. How do you measure whether a vision resonates? I think we can look at the people from the industry on a journey with us, including hundreds of study teams from major pharma companies and thousands of research staff around the world. There are also our employees, coming from a mix of clinical research and software backgrounds who want to work for us. Validation that we are going in the right direction comes from the champions within our customers who tell us they can’t run a trial without Teckro. Looking around the Corner For all we’ve accomplished in the past five years, there is still much to do. Any CEO who isn’t looking around the corner isn’t doing his or her job. But as I’ve learned in my career, great things happen by surrounding yourself with great people. To that end, I am pleased that Amanda Buckley is the newest person to join our leadership team as Chief Operating Officer. Amanda brings depth of knowledge in both the pharma industry as well as software best practices. I’ll let Amanda say her hello in her own words with a video she prepared – those of you who know Amanda know she isn’t shy! Five years is a milestone that we are all proud of. Yet, it’s a bit retrospective. With momentum behind us, it’s now time to look forward to the next five years and the great things still to come from Teckro. Never taking the odds for granted, it will be with the same level of passion, creativity and sense of urgency to help our customers deliver drugs that improve the quality of life and ease suffering for millions of people around the world. Videos from Amanda, Gary and thoughts from our employees on Teckro’s 5-year anniversary are also available on a dedicated milestone web page.
Blog
Apr 16, 2020
COVID-19: In This Brave New World It’s Time to Overcome Fear of Clinical Trial Technology
It's not an exaggeration to say that the pharma industry must operate at a pace that it’s never seen before to tame or even cure COVID-19. As billions of people live in some kind of lockdown, countries, businesses, and society in general cannot endure this kind of restriction indefinitely. And healthcare services – already stretched – cannot continue to operate under this heavy load. While we are resilient in the face of previously unthinkable situations, there needs to be a light at the end of the tunnel. Government leaders have a heavy burden to make the right decision of when to loosen or lift restrictions. And so, it is now that the pharma industry must step up to swiftly find a way to help us through COVID-19 and protect us in the future. In the “old world” -- before COVID-19 – it could take a decade for a new vaccine to come to market. Now, we are all counting on the industry to deliver treatment in months – something unthinkable before the year 2020. Traditional clinical trial timetables must be accelerated – safely accelerated – as the world waits for a solution. It’s with this speed that clinical trial technology can help pharma to truly transform. And it’s for this reason that Teckro is already supporting 5 COVID-19 trials with more on the horizon as sponsors race to safely set up COVID-19 trials. A stark reality has become evident: namely that clinical trial technology is not a “nice to have” but a “must have.” In previous articles I’ve discussed the paper protocol and how both inaccessibility and inconvenience of paper places an unnecessary burden on site staff and physicians. Before, during and after clinical trials, many questions need to be answered, such as which patients are eligible, which trials are suitable, how to manage a toxicity that arises, etc. The current environment creates all sorts of new dilemmas, meaning that it’s more important than ever that those involved use clinical trial technology. Here’s why: Rethinking Clinical Trials Social distancing isn’t exactly compatible with clinical trials. This is where rethinking how to best conduct the trials comes in. The issue is that there’s a fear of the unknown when it comes to conducting trials from a virtual or decentrialized setting. Data concerns, privacy worries and a very human suspicion of change have all been factors blocking change. Well, it could be that soon there’ll no longer be a choice. It may be difficult at first, but ultimately rethinking how clinical trial technology can open the door for greater diversity, with more underrepresented populations taking part. The time of travel to sites meant that those from more remote communities and women (who often have childcare responsibilities as well) haven’t been able to participate as much in the past. If this period of global standstill could be used to test out decentrialized clinical trials, they could well become commonplace in the future. This is good news for society because decentrialized clinical trials means more convenience and more diversity, which will ensure better drug development outcomes. Real-time Information The clinical trial protocol and other study documents when accessed through binders of paper are generally nowhere near the patient. If there is an adverse event and people are working from home, interaction costs could increase as no one will know how to access the information they need or even who has it! Real time communication can help to streamline discussions between site staff, CRAs and Sponsors, as well as help physicians make quick decisions. In the months ahead, real time communication will not be a luxury but a necessity to guide clinical trial safety and data integrity. In today’s reality, clinical trial technology is the only reasonable means to achieve real-time and yet still compliant communication. No Need to Travel! The pandemic has made us all rethink our priorities and discover what’s really necessary in the world of work. Some meetings and travel have proved to be superfluous, with videoconferencing doing the job just as well. The way clinical trials are structured, there are monitors across multiple sites, with each one potentially having a study coordinator trying to reach the CRA to interpret something in the protocol. The problem is that the CRA could well be travelling to the next site and unable to give the information needed, slowing down the whole communication process and potentially hindering the sites. In turn, Sponsors have limited real-time visibility into the clinical trials especially at the site level. By removing this friction, Sponsors can access site-level information to address issues hindering sites. As travel isn’t currently an option for anyone at the moment, it’s a chance to test clinical trial technology that allows staff to communicate in real time. Now Is the Time to Overcome Fear of Clinical Trial Technology There’s now a globally disrupted workforce and the clinical trial model needs to keep pace with this changing reality. After all, who knows what type of world will emerge in the next few years? The need for transparency, connectivity and mobile access to the protocol anytime, anywhere for all research staff is a necessity. And now, more than ever, the industry must get over the fear of clinical trial technology to adapt to the new reality. Do you have any thoughts on how clinical trials can embrace technology? As always, I'd love to hear from you. Please send your thoughts to connectwithgary@teckro.com
Blog
Mar 24, 2020
A Letter from Our CEO: Supporting Your Clinical Trials Without Interruption During COVID-19 Crisis
I would like to assure all of our clients that Teckro is well prepared to support your clinical trials, in spite of the COVID-19 pandemic. I understand that you are challenged with restricted movement of CRAs and patients, and that research staff are under pressure to treat those afflicted with the coronavirus (COVID-19). You can be rest assured that Teckro will do everything in our power to support your trials without interruption. Whether you have protocol amendments, need to change user access, or have users who need support from our helpdesk, our staff will be available. At Teckro, we have reviewed our existing pandemic plan, and we are updating as necessary. Like everyone, we are closely monitoring advice from local health and government authorities in all of the countries where we have staff. We have a dedicated task force that meets daily to plan and assign actions and to keep senior leadership current on any developments.   As with many businesses, we have taken the precaution to suspend all non-essential travel. Our global staff are working remotely from their homes until April 10, at which point we will reassess the situation. To preserve business continuity, we have core teams identified as well as second-in-command personnel for major functions, should the need arise.  From a product standpoint, Teckro software is built on a hybrid infrastructure between top-tier Equinix data center and AWS. Our Equinix-based infrastructure is fully redundant on each layer starting from power, connectivity, and throughout the application and database layers. Our AWS-based infrastructure is deployed across three availability zones for high redundancy. Teckro has robust DR procedures to allow a move from Equinix to AWS as required, which is tested on a regular basis. This is a global crisis that knows no boundaries of nations, races or beliefs. United as one, we will overcome this situation. I hope that you, your families and your employees stay in good health. If there is anything I or my staff can do to help you at this time, please don’t hesitate to contact us. Best regards, Gary This letter was originally published on March 12 and has been revised on March 24. Updates will be published here as necessary to provide current, ongoing information for our customers and business partners.
Blog
Feb 28, 2020
We Cannot Afford to Ignore the Lack of Ethnic Diversity in Clinical Trials
The importance of diversity in clinical trials cannot be emphasized enough – yet progress isn’t being made nearly as quickly as needed. Recent research shows that the levels of patients enrolling in a clinical trial as a first form of treatment for cancer in the US is just 0.1% and this is predominantly made up of White men with private insurance. A ProPublica analysis found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of Black patients were enrolled. Yet, African Americans make up 13.4% of the US population. Sadly, these statistics don’t surprise me. Ethnic groups have been underrepresented for as long as I can remember. This is a huge problem. Drugs can work differently depending on factors like sex or ethnicity, meaning people from different ethnic groups and genders may respond in hugely different ways to the same drug. But if there’s a lack of diversity in clinical trials, how will we ever know? Stand Up to Cancer Moves to Make Trials More Diverse Here at Teckro, our machine learning platform is used by more than 7,000 oncology sites worldwide and I recently wrote about Teckro’s goal to revolutionize clinical trials to help beat cancer on World Cancer Day. Therefore, I welcomed the news that Stand Up To Cancer (SU2C) have announced a ground-breaking new initiative to increase ethnic representation in clinical trials. All future SU2C-supported grant proposals will now be required to address how the research will consider ethnic diversity when it comes to recruiting and retaining patients. The move comes just a few months after the FDA announced a new focus on enhancing clinical trial diversity. These bold new developments force us in the industry to adapt, learn best practices and work to ensure the clinical trial population is a true representation of society. After all, diversity is crucial for safer, more effective medicines, so that researchers, regulatory bodies and patients are confident that a drug or therapy will reach the communities they’ll serve best. Here are a few more suggestions I have to help make clinical trials more ethnically diverse: Make participation easier. Currently time and travel commitments mean that taking part in trials is difficult for participants. By making trials more accessible, it will be easier to recruit from a wider variety of backgrounds. By using digital and virtual clinical trials, patients located further afield could be reached and the burden could be minimized by conducting some aspects of the trial remotely. Wearables, smartphones and tablets could also make participation more convenient. Build trust. For more ethnic communities to be engaged in clinical research, there needs to be improved relationship building and a better sense of partnership. Patients need to trust the research process, as well as the healthcare professionals involved and – it should go without saying - be treated with respect for their role in the trial. This can be achieved by having specific teams from local communities onsite to understand cultural sensitivities. As a result, more diverse clinical research communities will be built, leading to a more varied pool of participants. Improve awareness. Many potential participants don’t even know that clinical trials exist! The research community could change this by reaching out to local physicians to increase awareness of clinical trials. Resources could be provided to help them discuss the benefits with patients. In my previous blogs, I’ve mentioned how important it is to make the clinical trial process more convenient for physicians. And because physicians are typically short on time, they may not even be that knowledgeable about clinical trials themselves. Which brings me on to my final point… Increase education. Driving better understanding of clinical trials is an essential element when it comes to participation from a wider group. Providing proper education (using culturally appropriate materials) is a way to assist further understanding. And this goes beyond physicians handing out a few leaflets, ideally there would be strong local publicity campaigns – even nationwide conversations about the importance of ethnic diversity in clinical trials. Ambitious? Definitely. But a future of safer drugs, more efficient medication and lives saved, is one worth fighting for. Do you have any further thoughts on advancing clinical trial diversity? I’d like to hear them, please email me: connectwithgary@teckro.com.
Blog
Feb 04, 2020
World Cancer Day 2020: Progress Has Been Made - But We Can Do Better
World Cancer Day is a chance for global communities to unite, to show solidarity and pledge to work together to defeat this devastating disease. It’s also an opportunity to celebrate – we know more about cancer than ever before thanks to incredible breakthroughs in new medicines, advances in surgery and increasing scientific knowledge. The American Cancer Society has reported that cancer death rates in the United States alone fell 2.2% from 2016 to 2017 – that’s the largest single-year decline in cancer mortality ever reported. And cervical cancer could be eliminated by the end of this century, according to The Lancet, if cervical screening and HPV vaccination programs are scaled-up to 80% -100 % coverage over the next 50 years.  On one hand the decline can be linked to lifestyle changes, with smoking cessation contributing to the drop in the cancer mortality rate - lung cancer accounts for nearly one-quarter of all cancer deaths. But improved cancer detection tools such as new imaging technologies and less invasive surgical approaches have also played their roles. The official World Cancer Day site estimates that up to 3.7 million lives could be saved each year by mobilizing resources for prevention, early detection and treatment. Teckro’s Message on World Cancer Day, February 4, 2020  While we celebrate the breakthroughs made so far, the truth is that millions of people across the world will continue to die from cancer because new medicines are taking too long to get to market. Also, more than half of doctors who run their first clinical trials will never run another, meaning that patients’ access to trials are limited and therefore, so is the search for a cure. This is why our message on World Cancer Day 2020 is that we can do better. Much better. Clinical trials are stuck in another time, the burden on investigators and trial sites is increasing – which is quite extraordinary considering this technological era when we’re all so obsessed with speed and instant results! The cumbersome nature of the protocol puts physicians off participating and slows down progress when it comes to defeating serious diseases like cancer.  We’re proud that Teckro is leading the way in changing this reality. Our machine learning platform is currently being used to support more than 7,100 oncology research sites around the world. An impressive 77% percent of registered users are active on the platform ­– and it’s not required, so they are consciously choosing to use Teckro because the platform brings so much value to them.
Blog
Dec 18, 2019
The Secret to Clinical Trial Success: Unblocking Research Staff
There aren’t enough physicians in the world taking part in clinical trials. But what’s more troubling is that a large percentage of doctors who run their first clinical trial say they wouldn’t run a second one.  Physicians are the trusted advisor to patients. Without increased participation from them, it limits access to clinical trials for patients. Rather than trying to skirt the problem, we need to address core issues that limit why doctors don’t want to run clinical trials. Reducing Interaction Costs  Doctors generally have just a few minutes with each patient. This means they have a very short window to make critical decisions about the patient’s eligibility for a clinical trial. For larger research centers, this decision can be even more difficult if they are running several trials for different sponsors in the same disease area.  Given time pressures, logically speaking, it would make sense that doctors have quick and easy access to the information they need when they are with the patient.  Yet, access to the clinical trial protocol and other study documents today is primarily through binders of paper documents that are nowhere near the patient. Or, there may be electronic versions of the same documents that are hosted on a secure password-protected portal.  Neither approach is ideal for busy, time crunched research staff on the go. The reality is that high interaction costs – the time and effort to find answers – can limit trial success if it’s just too hard to find the information to make the right decisions.  Unblocking Research Sites Whether clarifying inclusion/exclusion criteria, managing a toxicity, or confirming the next steps from an adverse event, research staff will have questions that require input from experts. Sometimes the answers are time sensitive.  With so many channels – email, phone, text, chat – it’s hard to keep track for both CRAs and research staff. Email still seems to be the dominant channel, but it lacks any urgency for immediate questions.  Additionally, informing research staff of study or document changes is not straightforward as different sites may be on different versions of the protocol and located around the world. Newsletters are an effort to tackle some of the challenges, but that is still a generic, one-way broadcast. It is no surprise that communication is a common complaint among research staff. Without timely, accurate answers, sites are blocked. If sites are blocked, trials are blocked.   Considering the Research Site Viewpoint  Research staff have the best insights when it comes to patients. It is a wasted opportunity not giving them a voice with regards to things such as whether a trial should progress to the next phase or the viability of finding patients for a given study.  By asking for research site feedback, sponsors can gain valuable field-level intelligence that can influence trial success and future study design. Who better to give input than those who know the patients best?  Let’s not forget that investigators and research nurses are human. Asking for feedback has the potential for sponsors to foster better relationships with research staff. This in turn could make them the sponsor of choice and ensure that clinics want to manage their trials.  Giving Research Staff Confidence  It all comes down to confidence. Research staff need to have confidence they are making the best choices for their patients.  As the front line in any clinical trial, we need more doctors engaged. Giving them the tools they need to make informed decisions at each step could reduce friction for sites. And with more doctors participating, more patients will have the opportunity to participate in clinical trials.  This would be a win for everyone. Do you agree? Please let me know at connectwithgary@teckro.com.
Blog
Oct 08, 2019
On a Mission to Modernize and Simplify Clinical Research 
In the world of design, simplicity is achieved by removing, rather than adding more. The most elegant designs are those where there is nothing left to take away. Yet, a simple design is anything but simple to achieve as it requires a deep understanding of the purpose for the design.  At Teckro, we are applying the same concept of design simplicity to address today’s broken clinical trial process. You don’t have to look hard to find staggering evidence of how the industry is in desperate need of simplification. While there is nearly a three-fold increase in the number of trials just in the last 10 years, the practices to run a clinical trial haven’t changed in decades.  And while there are more trials, success rates aren’t necessarily improving. It is estimated that less than half of Phase II trials have successful outcomes. Of course, there are safety and scientific reasons that studies fail, which is the nature of clinical research. Our concerns are the avoidable blocking factors that stand in the way of success, such as too much paper, inconsistent communication, or a general lack of visibility into what’s going on with the study.  In today’s digital world, it is hard to believe that the primary interface for most clinical trials is a paper document or a PDF file that resides somewhere on a portal. Not only are these solutions impractical, they increase, rather than decrease, the interaction cost for busy site staff to fully engage with the trial. Unfortunately, the statistics reflect this with 40% of sites under recruiting and 80% of clinical trials failing to meet recruitment timelines.  Physicians have only minutes with each patient, and even less time to consider eligibility for a clinical trial. Yet, the protocol is rarely available where the patient is. These challenges of time and access extend beyond patient recruitment to all aspects of clinical trial compliance, including patient safety and toxicity management. The need for instant, reliable answers is paramount. At Teckro, we asked ourselves what can we take away to simplify clinical research? We’ve identified three key areas where we can modernize and simplify how things are done today so we can help protect patient safety and improve study quality:  Make all current, approved study information securely accessible in seconds anytime, anywhere through a smartphone or web-enabled device.  Create a secure, real-time digital connection to every stakeholder so that critical information and communication can be targeted to the right people at the right time.  Provide actionable insights into study performance so that issues can be detected sooner and proactively addressed.  By tackling these three areas, Teckro is bridging the gap between site staff and sponsors with a single platform. The focus is simplification. To design the most useful solutions possible, we spend countless hours of research and interviews to really understand the jobs that our users need to do.  Out of this deep understanding, we have solutions that make the process more transparent. Depending on the user, the questions are different. Site staff need quick answers to whether patients are eligible for a study, how to conduct a procedure, or how to manage an adverse event. Sponsors want to understand site engagement and whether there are early indications of any issues with the protocol or patient safety. All study stakeholders can use Teckro to find an answer to their study questions. Our corporate video provides a good explanation. By tackling complexity in clinical research, more sites will be engaged, their participation will be more successful, and they will extend access to more patients around the world. What do you think about our approach to simplicity? I would love to hear your thoughts. Please email me at connectwithgary@teckro.com.