Our sister company, PrimeVigilance, is the global leader in pharmacovigilance and specialized medical information services.
PrimeVigilance offers clinical and post-approval safety services across the entire product lifecycle, helping our partners with the effective management of their drug safety information.
We have a truly global clinical pharmacovigilance footprint through a presence in more than 100 countries and operating from offices in the United States, Europe and Japan.
PrimeVigilance services include the set-up and maintenance of global safety databases, as well as the collection, evaluation, analysis, and reporting of safety information to all regulatory authorities, ethics committees, and investigators.
We help in the preparation of safety narratives as well as drug safety update reports and annual safety reports to regulatory authorities. Our dedicated 24/7 phone and fax lines receive information on adverse events from clinical trial sites and post-marketing sources.
Compliant pharmacovigilance procedures across the lifecycle of your clinical trials is essential for the success of those trials and the prompt granting of marketing authorizations.
With extensive pharmacovigilance and safety monitoring services, PrimeVigilance can help you develop a robust clinical safety system for your product, including:
- Serious adverse event (SAE) management
- Integration, analysis, and interpretation of safety information collected from clinical trials, including medical review of individual case safety reports, signal detection and validation, aggregate report review, and risk/benefit analysis
- Expert safety input into the clinical development program
- Medical review by a safety physician, including causality, expectedness, regulatory recommendation, and analysis of similar events
- Safety database solutions, including leased validated systems or non-validated systems for early phase studies and optional remote access to client’s databases if available (e.g., Argus, AERS, etc.)
- SUSARs line listings preparation and submission
- Preparing regular SAE status reports, reconciliation of SAEs in safety and clinical databases
- DSUR writing and submission
- Expedited reporting, including the creation of regulatory forms and letters, submission to regulatory authorities, and participating sites or IRBs/ECs
- Safety management plans created for each study, documenting processes for all safety activities, creation of study-specific SAE forms and guidelines
- Reconciliation between safety databases and clinical databases
- Dedicated support team with in-house Oracle Argus expertise and experience with other safety systems
- SOPs, standard reporting/processing forms
- Tailored documentation: joint SOPs, safety management plans, etc.
- Consistency of safety data (i.e., MedDRA encoding conventions, collection of co-manifestations, etc.)
Why Choose PrimeVigilance for your clinical trial case processing and safety management?
- For over a decade, we have helped both emerging and established companies meet their regulatory obligations and to maximize product value.
- PrimeVigilance is the leading full-service pharmacovigilance service provider, delivering global solutions for clinical safety, post-marketing pharmacovigilance, and medical information to over 200+ clients worldwide.
- We maintain an extensive pharmacovigilance QPPVs network support and a premium portfolio of technologies to achieve state-of-the-art drug safety services.
- We have extensive experience advising on the submission of ICSRs for clinical trial phases I-III.
- 24/7 multilingual call center.
- We can provide clinical trials consulting services for clinical trials and products under development, supported by over 45 in-house medical safety physicians.
To find out more about all our pharmacovigilance and medical information services and expertise, please visit the PrimeVigilance website.