Innovation in clinical trials historically has been slow, and people often point to regulations and regulators as the reason. Are regulators truly the bottleneck? In this webinar, Jonathan Andrus makes the argument that regulators are actually a driving force behind innovation. This webinar will provide examples across the clinical trials process where regulators are not only supporting but encouraging innovation, including:
- Study design — requesting patient input on protocols, using novel trial designs that reduce patient burden, advancing risk-based approaches
- Study conduct — risk-based approaches to monitoring and study oversight, use of real-world evidence
- Post-study — faster approvals and adaptive pathways, early access to promising treatments, expanded use of post-market surveillance
Internal quality assurance (QA) and regulatory teams can be a hold-up when they rely on historical practices and personal preference rather than current regulatory guidance in assessing the feasibility and risks of implementing new and innovative solutions to clinical trial challenges. It’s time for sponsors, contract research organizations (CROs) and technology vendors to step up and join the evolution of clinical data management to data science — a strategic discipline enabling the execution of complex protocol designs in a patient-centric, data-driven and risk-based approach to ensuring subject protection as well as the validity of trial results.
This webinar will also include a real-life example of how CRIO used direct communication with regulators to resolve questions about the implementation of single sign-on (SSO) with electronic signatures — an area where previous regulatory guidance was ambiguous and predated the current infrastructure of SSO. Through these interactions, CRIO was able to achieve a path forward that is compliant, innovative and meets the needs of our clients.
Speaker: Jonathan Andrus, President & COO, CRIO
An active thought leader, blogger and presenter, Jonathan serves on the board and executive committee of the Society for Clinical Data Management (SCDM), and has been on the advisory boards of CDISC and DIA. Jonathan is co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative and a co-author on an upcoming eCOA Consortium publication.