Transforming drug safety through innovation and integrated services.
Bio-Prospera Clinical Research offers a full-spectrum solution for all your Pharmacovigilance needs, from basic medical inquiries to complex adverse event intake, case processing, and aggregate reporting. Our services encompass product safety, medical information, and regulatory compliance, all supported by our global, multi-channel, multilingual contact centers.
Whether you're a large pharmaceutical manufacturer optimizing drug safety across a diverse portfolio or a smaller biotech firm focused on a single emerging compound, Bio-Prospera is the ideal partner for enhancing your safety strategy.
Our end-to-end Pharmacovigilance services include:
- Medical Contact Center
- Individual Case Safety Reports (ICSRs)
- Medical Reviews and SAE Narratives
- Adverse Drug Reaction (ADR) Analysis
- Regulatory Compilation and Submission
Our team is composed of highly qualified professionals, including Pharmacists (M Pharma, MD – Pharmacology, Pharm D), Doctors (MD Pharmacy, MBBS), and Nurses (BSc Nursing), who manage every aspect of our Pharmacovigilance services.
Our Pharmacovigilance Managers and Medical Leads meticulously track all key project metrics to proactively identify and address issues, ensuring timely project delivery. Our experts specialize in case processing, writing individual case safety reports, narrative writing, SAE reports, triage, medical review, signal detection, risk management, and regulatory submissions.
With experienced medical and pharmacovigilance writing staff who possess healthcare degrees and specialized expertise, we ensure that all PV documents are thoughtfully crafted to meet regulatory standards. By meticulously documenting and formatting regulatory reports according to country-specific regulations, we provide pharmaceutical, biotech, and medical device companies with unmatched safety documentation and support. Our robust processes and skilled project management enable us to deliver high-quality results within established timelines.
