Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). Contemporariness is not new as it comprises the first “C” in the ALCOA-C guidance, but recent regulatory guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) has created new challenges and uncertainty within the industry with regard to its implementation in a trial master file.
Contemporariness is not just isolated to the trial master file, it presents a problem to multi-country studies spanning numerous regulatory agencies. The key challenges arise from not having clearly defined contemporariness in operational SOPs intended to ensure trial master file completeness; this has resulted in MHRA audit findings.
In an attempt to address the issue of contemporariness, sponsors and contract research organizations (CROs) have relied on resource-heavy and costly time-stamping of all incoming site correspondence to start the measure — but does this address regulatory concerns?
In this free webinar, the featured speakers will explore:
Charity Metz Schuller
Sr. Director Regulatory Affairs
Sr. Director, Clinical Operations
PRA Health Sciences
Chief Strategy Officer
Director, Industry Strategy
Oracle Health Sciences
Join Generis, Lorenz, PhlexGlobal, DocShifter and Qdossier to learn how the Alliance of Experts provides Intelligent Regulatory Information Management (RIM) offered by an alliance of established experts. Hear how we approach this first and foremost from a process perspective to ensure we walk you through the complexities of the business requirements.
Join Generis, LORENZ and PhlexGlobal to learn how the Alliance of Experts provides Intelligent Regulatory Information Management (RIM) offered by established experts in regulatory information management, content management systems, and electronic Trial Master File (eTMF) systems and services.