We at CRC Pharma firmly believe that “Medicines heal, but can also harm” and hence we also provide our clients with services to tackle the challenges related to drug safety i.e. Pharmacovigilance (PV).
We offer complete pharmacovigilance services from Phase I to post approval Phase IV studies. Our PV services includes Initial intake of adverse events from spontaneous sources and process them within safety database according to the ICH guidelines. We also provides medical communication services to answer any product related questions and also able to handle product quality issues and reimbursement requests as needed as per the client specifications. We conduct appropriate follow-ups with consumers and HCP’s in order to obtain complete clinical information pertinent to single case for its completeness. We also generate safety queries for clinical trial SAE reporting and follow-up with study investigators for completeness of the case.
Key services are :
- Serious adverse event (SAE) case processing of initial/follow-up reports
- Generation of case narratives, MedDRA coding, WHO-DD coding
- Responsible point for EudraVigilance
- Safety Data Management & Global Safety Database – Oracle Argus, ARISg and agXchange
- Signal detection integrity & evaluation by using EMPIRICA
- Development Safety Update Report (DSUR), periodic safety update review (PSUR) preparation and submission
- Pharmacovigilance Quality Assurance including SOP development
- Reconciliation of Serious Adverse Events for all studies and patient assistance programs
- Benefit and risk evaluation & risk minimization plan (RMP) and strategies
- Study documentation review and update, including protocol and IB