Clinical Research: Phase 1 - Phase 4

Setting a Real-World Strategy in an Evolving Clinical Research Environment

Presented by Stacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization, & Nach Dave, RPh. MSc, Vice President, Development Strategy

Since early this year, many standard clinical trial processes have been significantly disrupted. Patients have been prevented from attending regular physician visits. Clinical research associates who traveled regularly to study sites to review and verify processes and data were unable to do so. Supply-chain upheaval has forced schedule modifications and substitutions for products in short supply. Committees and boards accustomed to meeting in person were relegated to virtual gatherings. And clinical trial logistics had to be re-evaluated for time, cost, and quality expectations.

We need to change the way patients participate in trials and how we collect and monitor data. Adopting processes that are more flexible and agile while maintaining data integrity and quality has emerged as a primary focus for everyone involved in conducting clinical trials.

This webinar focuses on these process steps:

  • Quality data capture. What types of technology can be used to evolve processes that require a renewed focus on remote data capture? Where will the data come from and where will it live?
  • Information review. Once data becomes information, how will it be reviewed? What initiatives are driving collaborative, data-driven decision-making?
  • Data access. Who will handle the data? How it will it be transmitted and processed?