Clinical Safety and Monitoring

The CCI Clinical Safety and Monitoring group is comprised of two units under the leadership of the Medical Director Elizabeth Hexner, MD.

The Clinical Monitoring arm is responsible for monitoring CCI investigator initiated trials to ensure compliance with all regulatory and health authority guidelines and policies.The group monitors for protocol adherence and ensures the clinical site maintains accurate data transcription and reporting in databases. Monitoring reports are shared with the site and findings are resolved. Acute regulatory concerns are promptly shared with the sponsor team members and CAPA’s are initiated as required. The Clinical Monitoring team members are:

  • Diane Frazee, RN, BSN,  Associate Dir Clinical Monitoring
  • Ajibola Lateef, Clinical Research Monitor
  • Renita Livingstone, Senior Clinical Research Monitor
  • Kiriaki Serenidis, Clinical Research Monitor
  • Mary Truran, Senior Clinical Research Monitor

CCI Clinical Safety arm is responsible for the management, facilitation, identification, evaluation and reporting of adverse events observed in clinical trials in a manner consistent with applicable regulations, guidelines, policies and written procedures on behalf of IND Sponsors.  Their utmost concern is patient safety and timely reporting of all serious adverse reactions to IND Sponsors. The unit works closely with the physicians, clinical staff, clinical operations, scientific operations and regulatory team to collect, detect, monitor, assess, and report safety information throughout the course of the clinical trial. The group also compiles, reports and analyzes all associated safety data for inclusion in annual reports. The team members are:

  • Elizabeth Hexner, MD, Medical Director
  • Holly McConville, RN, Assistant Dir PV and Safety