From this author

No results found.

Feb 18, 2021
How Teckro’s Digital Engagement Platform Helps Biotechs Reach Their Full Potential
When most people think of clinical trials, they tend to imagine large pharmaceutical companies investing vast amounts of resources into developing life-saving drugs.  Here at Teckro, we work with 10 of the world’s top 20 pharmaceutical companies supporting their clinical trials with our digital engagement platform.  But this is not the full story when it comes to drug development and the role that biotechs play in delivering innovative treatments to the market.  In my role at Teckro, I work closely with both large pharmaceutical companies and smaller biotechnology companies, helping them run their trials more efficiently and safely. Not surprisingly, biotechs face a mountain of challenges when it comes to running clinical trials just like the big pharma companies.  Yet, unlike the industry giants, these biotechs don’t have the depth of people and financial resources nor the breadth in their drug development pipeline to sustain them if their research doesn’t yield successful results. Given the fairly low overall probability of success for drugs and vaccines, it is a fight for survival for smaller drug development companies.  It can mean an uphill battle for biotechs, who are competing with large pharma for high-quality investigators and research sites. And everyone in the industry is competing to recruit a diverse participant population. This is especially difficult for some therapeutic areas such as oncology, where estimates suggest that fewer than 5% of cancer patients participate in clinical trials.   Finding and retaining these people – from participants to investigators is no small challenge. I also would argue that it is a main reason why biotechs need to be nimbler and more innovative in how they approach their clinical trials than their larger rivals.  Let’s also consider that generally speaking, clinical trial design is increasingly complex. This means it’s just that much harder to ensure that protocol instructions are properly executed by research personnel.  For example, here are a few interesting takeaways from a recent research from the Tufts Center for the Study of Drug Development that demonstrate just how much protocol design complexity has intensified over the last decade:  The number of endpoints for Phase II and Phase III protocols have grown 27% since 2009. Phase III trials now collect on average three times more data, compared to 10 years ago. The mean number of distinct Phase II and Phase III protocol procedures have increased 44% since 2009. A Modern Approach for Faster and More Efficient Trials Ultimately helping smaller companies to run their clinical trials as safely and efficiently as possible will help us all. It supports the innovative scientific approaches that will hopefully result in more drugs, treatments and therapies on the market to tackle all sorts of disease areas, including rare diseases. Many of the biotechs we are working with are researching hard-to-treat diseases. Given the shift we’ve seen in the past few years of more drug approvals coming from companies that fall outside of the top pharma companies, I believe our digital engagement platform is well suited to tackle the challenges biotechs face with site engagement and communication of essential study guidance.  Here are just a few examples of how we are supporting biotechs to run speedier, cost efficient, high-quality trials: Correct protocol for sites: The last thing a biotech needs is to worry about is whether sites have the right version of the protocol. With Teckro, study teams can distribute the protocol and also manage versions or updates digitally. This saves time and money compared with paper-based methods still used in the industry.  Proactively sending clarifications: Updates, notifications and clarifications should be triggered to help sites as quickly as possible. This is where user search terms give our biotech customers visibility into questions their sites have. For example, during the COVID-19 pandemic, user search terms alerted study teams to the need to release COVID notifications to all sites because of the widespread search activity related to COVID. With Teckro, study teams can also send out the communication and track results.  Insights into site engagement: There is no time to waste when it comes to recruitment. With Teckro, our biotech clients can get real-time updates to see what sites are engaged with their study. And they can proactively reach out to help sites that aren’t meeting enrollment targets.  With the biotechnology market set to grow to $775.2 billion by 2024, we must address the problem of trial complexity and create a more accessible clinical trial landscape. Asia and Australia are fast becoming destinations of choice for biotech clinical trials due to the large patient pool, lower trial density and reduced costs.  The median number of patients recruited in oncology clinical trials involving sites in the Asia-Pacific region was over 40% higher than the global average in 2018-2019 trials.  For biotechs, it is a balance of speed, safety and quality for their clinical trials. Old methods of executing clinical trials work directly against these objectives. Manual, paper-based clinical trial operations just aren’t fit for purpose. And while we help large pharma to advance their clinical trial operations, our biotech clients benefit just as much – maybe more – in leveraging technology to support their drug development.  Cayce will be available for conversations during the OCT West Coast virtual conference Feb. 24-25. Come say hello! You can also book a meeting in advance here.
Oct 08, 2020
Part 2: Clinical Quick Reference Guides – The Ultimate, On-Demand Quick Reference Tool
In Part 1 of this blog series Clinical Quick Reference Guides - When “Quick” Isn’t Fast Enough, I talked about how clinical trial study teams have tried to help research staff manage with quick reference guides, aka "cheat sheets.” I never want to discourage efforts that support research staff as they need help on the frontlines to keep clinical research going. But the data shows that these cheats sheets really don’t result in dramatic time savings or reduce effort for site staff. So the question is: Why keep doing something that doesn’t work? In this blog, I want to challenge study teams to think differently about how they can really help research site staff. We’ll look at a new approach to quick reference guides that are more akin to how investigators, study coordinators and CRAs operate in their daily lives. (Spoiler alert: it starts with a smartphone.) Aren’t we in the 21st Century? I recently saw a post online by an individual in the clinical research industry asking for tips or methods for learning and retaining protocol content in order to increase efficiency.  Tips she got back from the community ranged from:    Printing the protocol and highlighting and/or adding tabs to sections Taking notes in OneNote or handwriting them Creating cheat sheets Using FAQ logs Creating an Excel sheet with the schedule of assessments Doing a PDF CTRL+F search of the protocol And then I thought to myself, Are we not in the 21st century?! Admittedly, some of the people who did comment called themselves “dinosaurs” and that their methods were “old school.” However, this young woman asking for guidance is starting off on the wrong foot. We rely on our smartphones to manage just about everything in our lives. And both information and interactions with our friends, families and colleagues are just a swipe on our phone away. And the great thing is no one has to be particularly tech savvy to benefit from a smartphone. Research staff getting answers to study specific questions should be as easy as taking out a mobile device from a pocket and asking a question – just like they do to find out the weather forecast or to send a quick message to a friend. Teckro – 21st Century protocol in your pocket The idea of cheat sheets, quick reference guides and FAQs is to give research staff fast answers to common questions. The limitations are that they are generally on paper, inconveniently stored, and outdated when there are study updates or protocol amendments. So what if we take this idea of fast answers and make them always available whenever an investigator, study coordinator or CRA has a question. What if the search for answers analyzed only current versions of the protocol and other study documents. And what if it was just in your pocket on your smartphone, where you instinctively go for any other answer. This is Teckro. It is the study protocol in your pocket. But unlike paper documents, it is also a lot more. It gives a wealth of insight that is particularly useful for study teams and monitors. On-demand answers that aren’t high maintenance. Teckro is always the right, approved version of the protocol. Amendments are handled seamlessly in the background so sponsors don’t need to worry if sites are referencing the most current version. CRAs don’t have to spend time to distribute amendments. And site staff (or study teams) don’t have to spend time creating cheat sheets. Saving just a few hours per week or per month is very valuable.  If you multiply that across all the studies happening at any given time, it could add up to days of improved productivity and more time to spend with patients. Schedule of assessment that is actually simple. As I mentioned above, one of the old tricks to make the schedule of assessments understandable is to create an Excel sheet with procedures in columns and visits in rows. Now this brings a host of problems, starting with the time it takes to actually create this file. And then, how is it maintained if there are changes? And where is the file available – on a desktop computer tucked far away from where treatment occurs? With Teckro, simply type in “visit schedule” and the instructions are returned from the correct version of the protocol.  Or more precisely, someone could type in “visit 14” and the procedures for this visit are returned in seconds. Study teams can also proactively send reminders or other timely guidance to research staff to help coach them for a given visit. This can help to reduce deviations and also improve the quality of care in accordance with the protocol.
Aug 27, 2020
Part 1: Clinical Quick Reference Guides - When “Quick” Isn’t Fast Enough
We spend a lot of time talking about complexities of clinical trials. But take a moment to consider, what actually is making things complex? First, there is the fact that the number of clinical trials is skyrocketing. From 10 years ago when there were 100,212 trials registered with, it is now projected that there will be more than 348,600 trials in 2020. The sheer volume alone puts pressure on research sites to support the needs of the industry.
Nov 08, 2019
#STEMDay “Never Stop Being Curious”
The lack of women today in STEM (science, technology, engineering and mathematics) jobs is a problem. We believe with more role models and positive examples of women succeeding in technical roles, we can change this. To honor STEM Day, we spoke with Teckro Director of Clinical Operations Cayce Drobek about why she pursued a STEM career and her advice to encourage more girls into fields of science and technology. By way of background, Cayce studied at Middle Tennessee State University, graduating with a bachelor’s degree in mental health and biology. She went on to complete two master’s degrees, one in microbiology and a second in clinical research. Cayce has more than 12 years of professional experience in clinical research, working on numerous Phase I-IV trials. In addition, Cayce also worked with multiple contract research organizations (CROs) and investigative clinical trial sites, and she is a Certified Clinical Research Associate. Now, Cayce is applying her domain expertise at Teckro, where among other roles she has managed teams responsible for the quality and accuracy of the clinical research content in the product. Cayce, what first prompted you to go into a technical role? I have always been drawn towards science, math and technology. I have always been a very curious individual with a strong desire to constantly increase my knowledge. Even as a young child, I loved playing with my microscope and was always conducting experiments in the hope of making exciting new discoveries. I still love conducting experiments, trying new things, and making discoveries to solve everyday challenges in my personal and professional life. Because of my passion for science, I studied biology as an undergraduate, and then microbiology in graduate school.  While in school, I worked as a study coordinator for obstetrics and neonatology trials.  In this role, I experienced many of the common clinical trial challenges that site staff face every day. I ultimately developed and rolled out new processes at the research center with the help of technology to reduce some of the burdens on the staff. I’ve worked with multiple technology systems in my years in clinical research roles. While many of these technologies were aimed at reducing my day to day work-related burdens, there was still a need for simplification. This is Teckro’s mission, and I wanted to be a part of a solution that could really simplify how trials are conducted. Did you have any special encouragement, or role models when you started out? My mother is the primary reason for me pursuing a career in clinical research.  While I was in graduate school, she unfortunately was diagnosed with cancer. Caring for a loved one with cancer was extremely difficult. Thankfully, after participating in a clinical trial at Vanderbilt University Medical Center, my mother had complete remission. I was so grateful that she had this opportunity and I’m now extremely motivated and passionate about being a patient advocate. I work to make these types of clinical trial opportunities available not only for those who have cancer but for all types of diseases and disorders. What does a career in a STEM field mean to you? Science is not just a job; it is a passion. If your career is something you enjoy doing, you will lead a happier and more productive life. Working in a STEM field provides me with the thrill of new, exciting discoveries. It allows me to travel the world solving global challenges. It gives me broad, marketable skills. And I believe it increases my career opportunities, not just in biology or clinical trial-specific roles but in also roles for technology companies who need clinical trials subject matter experts. I’ve become a better problem solver and gained a better understanding of how things work. And not least of all, it’s fun! What advice would you give to young women considering a STEM career? Never stop being curious! For young women interested in pursuing a professional degree and career in a STEM field, I would recommend starting off by doing some independent research into what education and opportunities are available. You can also join organizations that advocate for girls and women in STEM, such as those listed on Girls Who STEM. One of my favorite quotes is from Mae Jemison, the first female African American astronaut to travel into space: "Don't let anyone rob you of your imagination, your creativity, or your curiosity. It's your place in the world; it's your life. Go on and do all you can with it, and make it the life you want to live.” We are naturally born with a desire to understand how and why things happen the way they do. This desire drives us towards science, which provides us the path to illumination of the many mysteries of the universe.