The Baim Institute provides the necessary resources to process Serious Adverse Events (SAEs) that occur in a clinical study, enabling our sponsors to properly report instances to the competent authorities. Additionally, our in-house medical monitors provide review of safety trends and SAEs, as well as serve as a resource to sites for protocol and safety-related questions.
Putting Patient Safety First
First and foremost, the primary goal of any clinical trial is the protection and safety of its participants. To that end, the Baim Institute provides safety and medical monitoring for clinical studies. Our in-house medical experts, all of whom are board-certified MDs, provide the necessary review of safety data to identify potential safety trends throughout a trial. In addition, the medical monitor is available to answer general protocol questions and provide guidance to sites to clarify whether particular patients are eligible for the clinical study.
The Baim Institute provides safety processing for serious adverse events (SAEs) that occur throughout a clinical study. The Baim Institute safety officer reviews and processes the event, generating a descriptive narrative and completes the necessary regulatory forms (MedWatch, CIOMS), enabling the SAEs to be submitted to the required regulatory authorities.
Our Safety & Medical Monitoring team provides:
- SAE Processing and Reporting, including generation of MedWatch and CIOMS Forms
- Medical Review of SAEs
- Answering Protocol Questions from Sites
- Review of Safety Trends