Safety, CEC, and DMC Oversight

Safety Management and Study Oversight Committees

BBA’s Safety Management team is staffed with experienced (+15 years) registered nurses who serve as Medical Reviewers whose expertise allows us to support SAE and endpoint review specific to various therapeutic indications across clinical protocols.  They perform Unexpected Adverse Device Effect (UADE) and Serious Adverse Event (SAE) review and narration as part of event adjudication and reporting on pilot, pivotal, registry and outcome studies of various sizes.  This team supports all activities in concert with Clinical Events Committees (CECs).

The team is also comprised of senior staff (10+ years) experienced and knowledgeable in the oversight of Data Monitoring Committees (DMCs).  The team oversees the analysis for the review of patient safety outcomes occurring within a clinical study and provides this data to the DMC.

BBA’s team has experience working with Study Oversight Committees who provide integral services to support successful outcomes of clinical studies.  These multi-disciplinary committees are comprised of experienced experts within their therapeutic field.  They support the integrity of clinical study data by conducting an unbiased and independent review of endpoints and safety data to ensure objectivity. The BBA Safety Management team supports our roster of members established through our Physician Network using best practices developed with Sponsor partners.

Whether offered as a standalone service or as part of a full-service contract our Safety Management services include:

  • Medical safety review
  • Review of UADEs and SAEs
  • Safety narratives
  • Regulatory dictionary coding, report preparation and submission
  • Interim safety listings and reports
  • Preparation of listings for annual and study reports

Clinical Events Committee

BBA’s CECs are comprised of physician members with relevant therapeutic experience and medical knowledge of the product under investigation.  CECs focus on the adjudication of major endpoints in clinical trials providing a standard, systematic and unbiased assessment to determine whether they meet protocol-specified criteria across multi-center studies to ensure consistency of endpoint reporting.  CEC adjudication provides credibility to analytical data reported within a clinical study.

The CEC is responsible for the review and adjudication of events occurring during conduct of the study.  The CEC adjudicates events as defined within the clinical protocol.  The CEC operates in accordance with its charter and ratifies the charter prior to reviewing events.  The charter defines the scope and CEC’s responsibilities, quorum, guidelines and definitions for events to be adjudicated, supporting documentation and data required for review of events, and frequency of meetings.

BBA Safety Management team coordinates and manages CEC activities, including charter development, on-going CEC communications and meetings. BBA Safety reviews relevant source documents, CRFs, imaging and prepares narrative summaries to be presented to the CEC for review and adjudication.  CEC adjudication results are input into the study database.

BBA offers our customers the necessary expertise for successful implementation of endpoint adjudication activities for trials.  BBA’s Safety Oversight Group can manage the process from beginning to end, or work with customers on a customized list of services.

Our capabilities include:

Member Selection and Qualification

  • Identify CEC members, with access to a global pool of board certified physicians through our Physician Network
  • Manage member contracts and payments
  • Prepare HCP reporting for Sponsors

Charter and Process Development

  • Develop the CEC charter, in collaboration with Sponsors
  • Design and set-up the optimal CEC processes for each trial based on the clinical protocol and charter
  • Collaborate with Sponsors and CEC members to identify appropriate data required for adjudication

Committee Oversight and management

  • Coordinate meetings including agendas, logistics, hosting and minutes
  • Collection and maintenance of data related to clinical events
  • Review and narration of clinical events and conduct adjudication with CEC members
  • CEC adjudicated results are provided as part of interim and final statistical analyses
  • Serve as primary liaison between Sponsor and Committee, as required

Data Monitoring Committees

A Data Monitoring Committee (DMC), or Data Safety Monitoring Board (DSMB), is an independent panel of physician and biostatistician experts who periodically review clinical study data to ensure patient safety, trial integrity, and scientific rigor.  These members have relevant therapeutic experience and medical knowledge of the product under investigation.  DMC oversight provides appropriate data monitoring to oversee trial safety on an on-going basis to reduce risk to patients enrolled into the study.

BBA offers our Sponsors the necessary expertise for the successful implementation of DMCs.  An independent review performed by a DMC, can ensure trial data integrity as it relates to patient safety outcomes.  BBA’s Safety Oversight Group can manage the process from beginning to end, or work with Sponsors on a customized list of services.

Our capabilities include:

Member Selection and Qualification

  • Identify DMC members from a pool of board certified physicians and key opinion leaders through our Physician Network
  • Administer member contracts
  • Prepare HCP reporting for Sponsors

Charter and Process Development

  • Establish a written charter, with well-defined standard operating procedures for committee operations which are in accordance with the FDA Guidance, EMA Guidelines and ICH Guidelines
  • Collaborate with Sponsors to document pre-defined statistical stopping boundaries in the charter
  • Engage the DMC in identifying appropriate data required for safety review

Committee Oversight and Management

  • Coordinate meetings including agendas, logistics, hosting and minutes of appropriate sessions
  • Provide current data reports for periodic safety reviews and interim analyses with expert biostatistician guidance
  • Facilitate communications between DMC and Sponsor
  • Administer member payments
  • Serve as primary liaison between Sponsor and Committee, as required
The Boston Biomedical Associates team was instrumental in their support of AtriCure in executing our ABLATE trial, interacting with the FDA and preparing for the panel meeting. We are impressed with their extensive clinical and regulatory expertise as well as their professionalism and appreciate their support in working with us to achieve a positive panel vote.
— David J. Drachman, Former President and Chief Executive Officer of AtriCure, Inc.

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