In today’s pharmaceutical, biopharmaceutical and medical device product landscape, you can’t afford to miss crucial safety information about your products.
Clinical & Marketed Individual Case Safety Reports
Prepares regulatory-ready serious and non-serious safety reports for clinical and marketed products, ensuring full compliance with client-approved operating procedures from initial event capture to submission-ready regulatory forms.
Aggregate Safety Reports
Development of all clinical and marketed periodic reports for planned regulatory response, including country-specific reports.
Scientific Literature Surveillance
Provide outsourced options to support existing client safety organizations.
Safety Signal Detection
BioPoint can conduct all or part of your clinical and marketed signal detection and analysis.
Oversees the development of study design, data collection, and analysis plans, and prepares final reports summarizing study results.