855.554.5BIO info@biopointinc.com
Drug Safety / Pharmacovigilance

 

In today’s pharmaceutical, biopharmaceutical and medical device product landscape, you can’t afford to miss crucial safety information about your products.

Specialties

Specialization, Flexibility, Results

From preclinical studies to post-marketing settings, BioPoint has the broad-based experience to provide comprehensive clinical and post-marketed drug safety and pharmacovigilance consulting services to help you address product safety concerns in a confident, proactive manner.

A pharmacovigilance and drug safety expert from BioPoint acts as a direct extension of your team to assist with the following projects:

Contact Us
Case Study

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.

Epidemiology Consultation

Oversees the development of study design, data collection, and analysis plans, and prepares final reports summarizing study results.

Risk Management
We assist clients daily with the development of clinical and post-approval strategies. BioPoint also provides pharmacovigilance consulting and planning services, including the development of key clinical and marketed safety specifications and risk minimization plans.
Regulatory Consultation
BioPoint provides effective regulatory assessment and strategy for product development, including regulatory filings and other consultative services (e.g., post-approval commitments, new drug application strategies and regulatory agency advisory committee meetings).