Pharmacovigilance
With the changing scenario of drug safety and monitoring, stringent and dynamic regulatory requirements, it becomes pivotal for the biopharmaceutical companies to focus not only on the product development but also on the safety monitoring of the products during its phases of clinical trial and post marketing ADR. We at S2M Life Science having a clear understanding of drug safety requirements of global regulators, data management and integration, provide end to end pharmacovigilance support to our clients. Our robust IT infrastructure, technical experts and highly scalable universal capacity enables us to deliver the project in time. We tap into the value of clinical data by harmonizing the process and technology. We seamlessly support our customer in spite of emerging market, higher data volumes and frequently changing regulations. We are powered with 21 CFR (Part 11) and Eudra Vigilance compliant pharmacovigilance data base and Japanese Adverse Drug Event Report (JADER) database for the management of complete adverse events in both pre and post marketing setups. We create and maintain the database on behalf of our client. The database can be assessed by our sponsors and the Qualified person for pharmacovigilance in Europe (QPPV).
Our expertise
- Experience in providing end to end pharmacovigilance support to our clients.
- Clearly understanding of drug safety requirements of domestic and global regulators
- Capability to integrate and manage the data as per the standard regulatory guidelines
- Robust IT infrastructure, technical experts and highly scalable global delivery model.
- Powered with 21 CFR (Part 11) and Eudra Vigilance compliant pharmacovigilance database and Japanese Adverse Drug Event Report (JADER)database for the management of complete adverse events in both pre and post marketing setups.
How we work
Services offered
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Aggregate Reports
- Periodic safety update report (PSUR)
- Developmental Safety Update Report (DSUR)
- Periodic Adverse Drug Experience Report (PADER)
- Annual Safety Report(ASR)
- IND Annual Report(IND)
- Clinical trial Adverse Events (AE) handling and reporting
- Post-marketing Adverse Drug Reaction (ADR) handling and triaging
- Medical reviews, Narrative writing
- Expert statements, investigator notifications
- Aggregate reporting
- Medical writing services
- Call center and helpline
- EU Qualified person for Pharmacovigilance (QPPV)
- Medical information
- Signal Detection & Evaluation
- Development Safety Update Report (DSUR) preparation and submission
- Global Literature Search & Review in support of the DSUR
- EudraVigilance reporting using EVWEB
- Case Narratives
- Serious Adverse Event Case Processing of Initial/ Query follow-ups
- Legacy case transfer
- Integrated summary of efficacy
- Integrated summary of Safety
- Company core data sheet/safety information
- Summary of Product Characteristics
- Package inserts
- Patient information leaflets
- Pharmacovigilance system master file (PSMF)
Our USP
We strive to deliver highest quality services, customized to our clients's specific requirements in time by
- Tapping into the value of clinical data by integrating the process and technology
- Seamlessly supporting our customers for both emerging or frontier markets, as well as for higher data volumes and frequently changing regulations
- Creating and maintaining the database on behalf of our clients; the database can be assessed by our sponsors and the Qualified person for pharmacovigilance in Europe (QPPV)
- Our ability to receive, triage, review and process data from various sources on time, within budget and meet quality standards
- Performing data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines
- Facilitating the electronic submission of report to the regulators through electronic gateway
- Processing the adverse events according to the ICSR guidelines and entering the triage date in to the database with the respective date of action and closure
- Processing safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements
- Paying attention to minute details of individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information, or other service lines as appropriate
- Integratingour work with a robust operations team for back-ups, generation of status reports, generating project metrics, drafting project instructions/guidelines and implementation of new processes, etc