February 18, 2021
How Teckro Helps Biotechs Reach Their Full Potential
Clinical Operations LeaderGuest
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.
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 Teckro 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.
Clinical Operations LeaderGuest
With over 15 years of industry experience, Cayce has expertise on clinical site operational efficiencies, engagement and analysis as part of delivering patient-focused experiences.