Discover a groundbreaking webinar delving into regulatory innovations in clinical trials, assessing new tech compliance and enhancing data quality while reducing site and patient burdens. 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.

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Join this webinar to gain insights into how regulators encourage clinical trial innovation, methods for assessing compliance implications of new technologies and available technologies to improve data quality and reduce site and patient burdens.

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Speaker

Jonathan Andrus, President & COO, CRIO

An active thought leader, blogger and presenter, Jonathan Andrus 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.

Message Presenter

Who Should Attend?

This webinar will appeal to:

Clinical operations personnel
Data management and data science personnel
Clinical research coordinators and PIs
Regulatory and QA professionals

What You Will Learn

Attendees will gain insights into:

How regulators are encouraging clinical trial innovation
Methods and resources for determining the compliance implications of new technologies
What technologies are available to improve data quality as well as the site and patient burden

Xtalks Partner

CRIO

CRIO is an eClinical solution provider delivering innovative data capture technology for sites, sponsors and CROs. As the industry’s leading eSource provider, CRIO‘s unique architecture enables a single point of data capture that embeds quality and transparency at the point of entry, and creates significant downstream efficiencies. Finally. One system. One source.