Section of Medical Safety
Welcome to ATRI medical safety
The Alzheimer’s Therapeutic Research Institute (ATRI) brings together the innovative, experienced and dedicated talent required to design and oversee every aspect of rigorous clinical trials.
Our Medical Safety team is responsible for clinical monitoring of sites to ensure proper study conduct as well as medical monitoring to ensure medical oversight of participant safety. The unit also interacts closely with Study Sponsors and the Data and Safety Monitoring Board (DSMB).
Our Activities
The Medical Safety Unit at ATRI is dedicated to ensuring participant safety, protocol adherence, and maintaining the highest level of data integrity. With clinical site monitoring and medical monitoring as key functions, we provide crucial oversight throughout the entire clinical trial process. From protocol development to study closeout and data lock, our team collaborates with sites, vendors, and research partners to ensure the safety and well-being of participants. We work closely with site Principal Investigators, who hold ultimate responsibility, to safeguard participants and ensure strict adherence to the study protocol.
Medical Monitoring
- SAE reviews
- AE MedDRA coding
- Eligibility questions
- Medical management questions
- Abnormal lab/ECG/MRI reviews
- Protocol deviation reviews
Clinical Monitoring
- In-person and remote site visits
- Site communication and documentation
- Study timelines and deliverables
- Source Document Verification
- Drug Accountability Review
- Query resolution