Medidata Blog

Clinical Trial Technology and Complexity in the Real World – Why You Need a Flexible EDC System

Sep 12, 2023 - 4 min read

"Change is inevitable. Change is constant." – Benjamin Disraeli.

All elements of a clinical trial are tightly controlled, but studies are increasingly complex, protocol amendments are common, and recruitment is unpredictable. In addition, our world is changing constantly and rapidly, directly impacting both trials and subjects. Unpredictability is part of the clinical trials landscape.

Not all systems are created equal. Standard Medidata capabilities—such as being genuinely scalable, from simple, single-site, Phase I studies to complex, therapeutic, multi-country, multi-site, diverse, multi-arm oncology trials—are challenging for many other systems.

Examples of unforeseen changes include the pandemic-driven shift to decentralized clinical trials in 2020, the ongoing global economic crisis, and the meteoric rise in interest in AI for clinical trials in 2023.

Can technology predict the unpredictable? No, it can’t. It may contain a certain amount of configurability based on current and past experience, but a system without custom functions can’t accommodate every unique, unpredicted, complex requirement or change. A one-size-fits-all approach—such as an attempt at delivering a 100% configurable system—introduces unnecessary limitations to your study. Also, with a flexible system, the system adapts. With an inflexible system, you have to adapt.

Addressing Unpredictability and Complexity

Change can be rapid, unexpected, and disruptive; it requires adaptation to something new—often at speed. In the complex, unpredictable, and ever-changing world of clinical trials, Medidata Rave EDC has proven how flexible, adaptable, responsive, and innovative it is by successfully supporting 33,000+ studies.

Rave EDC is highly configurable and tailorable, with access to a large, expanding library of custom functions. Medidata and our customers can build new custom functions if needed for maximum flexibility.

"...the Medidata products are very innovative and support our very complex oncology studies..."

– Vijay Chundru, Senior Director, EDC Programming Team, Global Clinical Data Operations, Jazz Pharmaceuticals

With an ongoing focus on continuous improvement, Medidata reduces the need for custom functions by (a) building in more standard functionality and (b) eliminating the need for edit checks that may never execute because they validate very rare cases.

There are three core reasons why Medidata Rave EDC is a firm favorite for clinical data management, clinical operations, and clinical database programming teams:

1. High Configurability

Most of the build for Rave EDC studies can be done without the need for custom functions. 95% of the elements of a study can be configured. Both Medidata and our customers have libraries of reusable custom functions to speed up new study builds. With Rave EDC, customers can use our Professional Services team or build their own studies, however complex. Other solutions may require a vendor to develop additional functionality to support a specific protocol.

Summary

95% of CRFs in Rave EDC are created with configurable UI
The remaining needs are addressed by:
Recyclable Custom Function Library Template
True Custom Functions ~ 1-2%

2. Flexibility

To enable support for any protocol, including complex adaptive designs and master protocols (Basket, Umbrella, and Platform), Rave EDC provides the flexibility to tailor the study build and to execute any protocol amendment or other mid-study design change.

3. Transformational Study Build Processes

Medidata is committed to simplifying processes without sacrificing quality and effectiveness. Our next-generation study design solution transforms the process by enabling more study-build configuration through the user interface. This new approach includes complex casebook dynamic behavior. Because clinical data capture is no longer just about EDC, we’re centralizing the definition of a study across applications, including creating edit checks and data definitions that are data source agnostic (i.e., the same data definitions and edit checks would apply, whether collected via EDC or eCOA).

Many edit checks we program today (to deal with all possibilities) never execute. In a recent analysis of studies at a large pharma client, anywhere from 45% to 75% of programmed edit checks were found never to have been executed.

Medidata is facilitating a more intelligent, risk-based approach to study build. We ensure data quality by focusing edit check development on the most common scenarios and leveraging AI/ML to detect data anomalies as part of our next-generation data platform supporting the evolution of clinical data management to clinical data science. This will, in turn, reduce the amount of custom programming required to implement studies.

These three core points lead to streamlined study builds, accelerating the study build process for many clinical trials.

Conclusion

To address the complexity and unpredictability of the clinical trial landscape, the only logical technology choice is a system that has the functionality, adaptability, and flexibility to align perfectly with your study. This means you need a system that’s configurable, leverages pre-existing custom functions, and can add new custom functions for unique requirements. If your EDC doesn’t have these, it won’t scale and won’t be able to support the growing number of complex/innovative trials.

This flexible approach is one of the core reasons why Medidata’s Rave EDC has been the system of choice for over 33,000 studies.

Medidata's Professional Services team works with you to understand your study goals, study design, and any unique requirements. Alternatively, our training team empowers you to build your own studies.

We understand complexity and unpredictability need to be addressed, not ignored.