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Transforming Clinical Trials

By Study NeedBy Study Role

June 24, 2021

Behavioral Data from Teckro Changes the Game in Clinical Trials for Both CROs and Sponsors

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    There is a natural synergy between Teckro and contract research organizations (CROs). As a software company, Teckro develops best-of-class technology to improve communication and collaboration among clinical trial stakeholders. In comparison, CROs provide a range of services to biopharmaceutical companies to assist from clinical development to commercialization.

    Teckro provides “behavioral” data associated with clinical trial operations, which until now has been out of reach for both CROs and sponsors. Think of it as the “why” and “how” behind the decisions that sites make throughout a clinical trial.

    Historically, the clinical trial industry has been built around clinical data, providing insights into everything about a participant – medical history, health status, treatment results, etc. Of course, this data is critical to support the end goal of any clinical trial, which is to prove that a drug is safe and effective.

    What Teckro offers is something completely new: a real-time lens into what is happening on the ground during clinical trials.

    Visibility on the Ground

    Let’s consider an analogy to illustrate the point. You send your children to school, but it is a bit of a mystery what happens during the day. Sure, you can talk with them (or try at least if they are teenagers!) when they get home to see how their learning went for the day. You might go to parent-teacher conferences to get a status from the teachers. And you see their report cards that equate performance to a grade with perhaps some commentary from the teachers.

    The gap here is that you get the result, but you don’t have real-time visibility into all of the factors that led to the result. You have some oversight. For example, you may drop off your children at school so you know they are there in person and when they arrived. And you may observe and even help with homework. But wouldn’t it be nice to know not only the grade but also what it took to get that grade? For example, did a particular problem or subject take your child 10 attempts to get right? It’s this depth of knowledge into the “why” and “how” that tells a more granular story than the report card or final grade.

    It’s this depth of knowledge of what’s happening on the ground at study sites that makes Teckro valuable to CROs and sponsors. With Teckro, they gain insight into the “why” and “how” of clinical trial decision making by investigators and research personnel.

    Understanding what led to decisions is just as critical as the decision itself to optimize the process. It’s not about simply seeing a datapoint because context is everything. It is valuable to know that a site looked at the eligibility criteria of a protocol 20 times before enrolling a patient. Or that no one from a site looked at the protocol even once and hasn’t enrolled a single participant. It’s the why and how behind the enrollment figures.

    It is also useful to know if investigators in several different countries all start asking questions about how to address a skin reaction. Going a step further, it is valuable to know that a medical monitor responded to the investigators’ questions looking for expert advice within minutes and what exactly was said. It is the how behind simply saying, “question resolved.” This type of data is vitally important to optimize performance and proactively get ahead of issues before they escalate.

    Data and the Crucial Context

    The last thing a CRO wants to do, however, is to introduce technology that sites won’t like or use. Here at Teckro one of our main motivations is helping to make life easier for sites. Right now, they can spend a day or two trying to resolve an issue using outdated communication methods such as telephone and email. And sifting through paper protocols that are inconveniently stored away from the point of care.

    Teckro provides a way for a question to be immediately answered, alleviating much of the burden put on site staff.

    The pandemic has left a backlog of clinical trials in its wake, and it will take a lot of work and effort from CROs and sponsors to get them back on track. The opportunity is there to ensure that CROs and sponsors have access to not just data but the crucial context about the data for faster, more efficient, safer trials. With Teckro, CROs are thinking different about the potential for data to do just this.