In the midst of the COVID-19 pandemic, more than ever before, BioPharma companies are looking to bring agility, velocity and acceleration to their clinical development programs in order to bring new products to market to address unmet medical needs. This is, of course, essential for COVID-19 vaccine trials but it has also become the catalyst to rethink the clinical development process for a new age.

Digitization of the clinical development process is the single most impactful strategy for transforming and accelerating clinical trials. The TransCelerate Digital Data Flow Initiative highlights the value of beginning digitization at the protocol. A digital protocol platform, driven by standards, explicitly ties the protocol to downstream standards for data collection, SDTM, etc. In fully digital form the protocol objectives and endpoints can drive the Schedule of Activities with a high degree of fidelity, sufficient to automate the study database build and shave 50% or more of the final protocol to FPFV cycle time.

A digital platform helps companies accelerate clinical development by adopting the Lean Protocol™, an end-to-end approach to front load and parallelize clinical trial processes based on a collaborative environment for developing digital study protocols. Standards driven digital protocol development is essential to Lean Protocol™, shortening the clinical trial life cycle by both controlling the critical path and by streamlining and automating downstream processes from protocol authoring to submission.

A digital platform and Lean Protocol™ process shifts focus to critical data in a gated workflow to drive functional plans and processes in a quality by design approach. This provides a solid platform for other innovative solutions such Saama’s ML solution for automating EDC queries to bring even more efficiency to the study close out stages.

---

Technical support:
Click on the help button on the bottom right, select contact support and email the BlueSky team with any technical issues. Otherwise e-mail directly to support@blueskyelearn.com or call +1-888-705-6002 for immediate help.

General support:
The SCDM Learning team is here to help. Contact us at learning@scdm.org or call +32 232 024 87.