Our PV SMEs, comprised of both Physicians and Researchers are end-to-end partners for our clients, proactively advising and collaborating in designing and maintaining PV services and systems which are fit-for-future.
Clinical Safety Services Include the following:
Collection, evaluation, analysis, and reporting of safety information, including serious adverse events, unanticipated adverse device effects, and other significant safety events
Safety narrative writing including physician review
Coding (MedDRA, WHO Drug) of adverse event information
Assessment and evaluation of reportability and submission of reportable events to global regulatory authorities
EudraVigilance reporting and e-reporting in the EU
Provide expertise on safety-specific national regulatory requirements in many countries worldwide
Preparation and submission of annual safety reports, six monthly line listings, and periodic reports to global regulatory authorities
Custom safety surveillance including adverse event and laboratory data review and trend analysis
Adverse Event (AE) and Product Complaint (PC) management
Individual case reporting and global call center function
Safety database services
Global literature and media monitoring process that includes search strategy and review
Safety signal detection and aggregate report management
Region-specific pharmacovigilance management such as:
Maintenance of a certified pharmacovigilance system (i.e. PSMF) for pharmaceutical companies in the EU
European Union-qualified person for pharmacovigilance (QPPV)
Risk management plan development and maintenance
In-country pharmacovigilance services (including local literature surveil-lance and national contact persons)
EudraVigilance profile management
Post marketing Safety Services Include the Following
