SGS’s Drug Safety and Pharmacovigilance services provide comprehensive and flexible solutions for the active management of drug safety pharmaco/device vigilance and risk management during the complete lifecycle of a medicinal or medical device product.
Our multi-disciplinary team offers complete safety solutions:
- Therapeutic, technical and operational excellence
- Tailor-made and cost effective safety solutions for small and mid-size companies
- Flexible outsourcing of safety functions
- Safety physicians with broad therapeutic expertise for medical monitoring, review and signal detection (CIOMS IV and VIII)
- A team of QPPVs for registered products in EU
- Up-to-date information country-specific regulatory requirements
- Robust quality system
- Pharmacovigilance training, consultancy and education
Starting in early clinical research, our fast and tailor-made solution help you meet your safety requirements, from set-up to expedited and aggregate reporting.
Individual case safety report management is performed with our in-house safety database (Trace®) or your own preferred safety system. Our flexible team ensures timely case entry and query management of Individual Case Safety Reports (ICSR), Serious Adverse Events (SAE), Adverse Drug Reaction (ADR), pregnancy and other clinical/spontaneous cases of interest, while guaranteeing accurate coding and reconciliation with clinical databases.
SGS’s Safety Physicians (MD’s) provide quality medical review of individual cases and line listings, specialist medical consultancy (risk management planning, signal detection), act as (deputy) local Qualified Person for Pharmacovigilance (QPPV) in behalf of your company, all with 24/7 availability.
Our regulatory submission group ensures compliant expedited and periodic reporting of individual case safety reports (CIOMS I, MedWatch) and periodic reports to Regulatory Authorities, EC and IRBs conform country specific reporting requirements. SGS Eudravigilance specialists register your company, act as responsible person, and ensure E2B compliant electronic reporting to EMA and EU Regulatory Authorities.
Safety related report writing (case narratives, Annual Safety Report (ASR), safety sections in NDA/IND annual reports or IB, DSUR, PSUR, clinical evaluations for devices, safety summaries, etc.) is performed conform latest regulatory and medical writing standards.
We manage your Data Safety Monitoring Board activities (DSMB, DMC, Endpoint Committee or other), including the charter writing/review with specialist input from statisticians and board members, unblinding of data and presentation of data from the safety database.
If you are registering products in Europe (MAH), our post-marketing pharmacovigilance services will advice you and help ensuring continuous monitoring of quality, safety and efficacy of your marketed product.
Find out how SGS can help with your drug safety, pharmacovigilance and device vigilance requirements.