Adverse Event Intake and Processing

PROSAR offers a systematic approach to adverse event intake and processing. Our staff of experienced nurses and pharmacists are available 24/7 to receive adverse event calls and e-mails from consumers, patients and healthcare professionals. This ensures the most complete and accurate case reports. Each call is documented in the PROSAR Safety Database™, a secure case management application. Clients have on-line access to their case data around the clock.

PROSAR can manage all of your AE processing including call intake, creation of MedWatch 3500A reports, preparation of periodic reports and medical literature searches to identify reportable cases. Our services are customizable, allowing you to subscribe to call center services only or to have PROSAR also take care of part or all of case processing and reporting. PROSAR is equipped with state-of-the-art technology and our systems and processes are compliant with 21 CFR Part 11. Our quality assurance program uses a risk-based model to define, implement, manage, evaluate, and improve internal business processes.

Benefits to you:

• Enhanced customer satisfaction as a result of providing access to healthcare professionals 24/7
• Reduced need for staff and infrastructure, allowing you to use resources in other areas
• Ability to be involved in case processing at your desired level
• Peace of mind knowing that FDA adverse events are documented and processed by experienced and dedicated healthcare professionals following FDA standards