New FDA Safety Reporting Regulations: Compliance Automated with ACI

BALA CYNWYD, Pa., Sept. 7, 2011 /PRNewswire/ -- Applied Clinical Intelligence, LLC (ACI), an industry leader in clinical endpoint adjudication committees and independent data monitoring committees, provides integrated and highly efficient risk reduction solutions for clinical research.  ACI has deployed its automated solutions to hundreds of trials in over 50 countries over the past 10 years.  For more information, please visit www.a-ci.com.

Effective as of March 28, 2011, the FDA published a regulation to enhance the process of monitoring and evaluating patient safety in clinical trials for IND applications.  This regulation specifically deals with the reporting of serious, unexpected adverse events that are suspected of being caused by a study drug.  Under this regulation, investigators are obligated to report all serious, adverse events to the sponsor, whether or not they may be drug-related, within 15 days and all fatal adverse events must be reported within 7 days.

The new regulation demands a more detailed analysis of the entire safety database by the sponsor rather than relying on an investigator to determine the cause of an event solely based on individual case circumstances.  The new approach is meant to provide a more complete and meaningful analysis of safety parameters for a new study drug by having the sponsor evaluate events in the context of the entire study database. The regulation is accompanied by a draft FDA guidance document that describes expert committees as a key element of a systematic approach to safety surveillance and monitoring.  Together, these regulatory changes and recommendations aim to enhance patient protection in IND clinical trials.

ACI's clients are ahead of the regulatory curve, thanks to its fully automated adjudication platform (AIMS™) as well as its online data safety collaboration tool, ClinicalSafety.net™, which allows rapid and thorough review of safety trends within an entire study database. ACI's clinically-focused DMC reports display aggregate safety data enabling sponsors to confirm quickly and easily that they are meeting the requirements of this new FDA regulation.

ACI's iCommittees™ offering is a single, integrated solution which combines over a decade of expertise in the management of clinical endpoint adjudication and data safety monitoring committees with a proprietary, regulatory-compliant technology platform and a global network of scientific experts. iCommittees™ experience spans multiple therapeutic areas and indications, early phase through registry studies, and has a global footprint.  For more information, visit www.icommittees.com.

Contact: [email protected], +1-484-429-7200

SOURCE Applied Clinical Intelligence, LLC