The number of drug and device clinical studies is growing by more than 10 percent each year. The complexity of these studies is also increasing rapidly, and in the name of patient safety so are regulatory expectations. You are facing tougher operational burdens — inspection regimes, business growth, physician and patient reporting — making it hard to keep up. Chiltern’s Pharmacovigilance team can relieve that burden.
Our global Pharmacovigilance teams have the knowledge of local regulations, standards of care and cultural customs you need to identify and assess risks during your clinical trial — keeping patient safety a top priority. And, we have locations around the world to accommodate your trials wherever they are.
We understand what is important to you, so we strive to provide flexible, scalable operations that meet your quality and efficiency expectations. Our team collaborates to minimize risks with effective monitoring, assessment and reporting of safety information throughout the duration of your program and the life cycle of your product.
Keep your project momentum when you trust Chiltern’s Pharmacovigilance team to manage your product safety program.
- AE/SAE reconciliation
- Aggregate analysis and support for safety review committees
- Case narratives
- Expedited reporting (IND safety reports, SUSARs, medical device and post-marketing reports)
- Literature review
- Periodic reporting (line listings, DSURs, PSURs/PBRERs and PADERs)
- Receipt and processing of SAE/SADE and AE/ADE reports
- Reporting to regulatory authorities, EudraVigilance, IRBs/IECs and investigators
- Safety database
- Safety management plan
- Signal detection and analysis
- Site, team and reporter training