Efficient Management of Adverse Event Adjudication

Data Monitoring Committees help ensure the integrity and quality of data in clinical studies by providing non-biased safety oversight and adjudication of adverse events. In recent years, FDA has increasingly scrutinized data monitoring processes and the potential impact of sponsor influence.

RCRI is uniquely positioned to remove any perceived bias by providing independent management of the sponsor’s Data Monitoring Committee. Our consultants fully understand the operational and safety management processes required to execute the full scope of activities.

The RCRI Difference:

  • Over the past five years, we have successfully managed over 45 Clinical Events Committees (CEC) and Data Safety Management Board (DSMB) meetings across a wide variety of device types and therapeutic spaces.
  • Our project managers and clinical research associates have extensive operational experience managing the entire “safety event” lifecycle within regulated clinical studies. This knowledge translates to efficient and effective management.
  • We understand the importance of members maintaining a clear understanding of both their responsibilities and protocol definitions.
  • Our therapeutic knowledge helps us efficiently identify required source documentation. Plus, our staff of clinical experts and epidemiologists writes clear, concise, and accurate adverse event narratives.
  • Strong project management acumen to keep members and meeting preparation activities on task and on time. We have developed a number of standardized processes and procedures; however, we are flexible and able to utilize either RCRI or sponsor standard operating procedures as appropriate.
  • We are comfortable deploying a variety of meeting/adjudication strategies to meet the unique needs of each project. For instance, we have managed meetings via teleconference, webinar, face-to-face, and through use of remote adjudication procedures.

Services include:

  • Identify and recruit physician and other expert members.
  • Execute member contracts and manage payments.
  • Develop charters and conduct training of members.
  • Organize and schedule standard and urgent review meetings.
  • Collect, prepare, organize, and distribute meeting materials in a variety of formats.
  • Provide administrative support leading up to, during and after meetings.
  • Document meeting minutes and adjudication responses.
  • Conduct additional follow-up and notification activities as needed.

Contact us today for an appointment and consultation.

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Regulatory and Clinical Research Institute

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