Medical Monitoring & Safety Review

As Medical Monitors (Clinicians), we care for all aspects of the research and clinical trials. Our role is to ensure the integrity of the data and the ongoing safety of the subjects enrolled in clinical studies. We provide such leadership by remaining available to sites and sponsors continuously for the course of the trial. We provide leadership oversight for the project overall from recruitment to completion, report and publication.

As Safety Reviewers (Physicians), we review safety data and Adverse Events on an ongoing basis, ensure that Serious Adverse Events are thoroughly documented, properly summarized and reported timely and meaningfully1,2 to the relevant authorities. We use sophisticated tools to monitor the safety profile of the product and detect safety signals. Potential safety concerns are promptly brought to the attention of the sponsor and the DSMB. Information about Serious Adverse Events is stored in our proprietary safety database, thus making its retrieval and reporting extremely easy.

As Medical Monitors and Safety Reviewers we contribute to Data Safety Monitoring Boards and Data Monitoring Committees. If so desired, Anabase can organize and manage such committees.

  1. Safety Reporting Requirements for INDs and BA/BE Studies - 2010
  2. Adverse Event Reporting to IRBs ­ Improving Human Subject Protection - 2009