Medical Affairs and Safety

As your clinical trials continue to grow in size and complexity, it is critical to have knowledgeable and experienced physicians and health care professionals on your team. The AAIPharma Medical Affairs and Safety team offers you strategic guidance and leadership in all the essential aspects of managing the clinical development of new products.

Qualified and experienced in the development process, our medical doctors work in close concert with our expert Regulatory Affairs staff and the clinical project team.

AAIPharma's physicians are actively involved with the project team and vitally important to the success of your study. One of the most important functions of any medical affairs group is safety monitoring and serious adverse event (SAE) management. AAIPharma gives special attention and oversight throughout the course of a trial to ensure that patient safety is paramount and risks are minimized.

With the ever-present potential for serious adverse events, our Medical Affairs and Safety group will ensure the events are properly identified and thoroughly investigated, reported, and tracked in accordance with GCP and your specific requirements.

AAIPharma provides medical and scientific writing support at all stages of the development life cycle. Our medical writers work in close collaboration with input from other expert team members to ensure conformity to appropriate regulatory requirements and that the consistency, accuracy, presentation, and quality of the document contents and statistical analyses are of the highest standard.