In today’s biopharmaceutical product landscape, you can’t afford to miss crucial safety information about your products. We can help.
Ethicare Pharmacovigilance is uniquely focused on providing comprehensive and customized pharmacovigilance (PV) services and offering specialized services to augment or support any drug safety department, tailored to fit your needs.
Experienced and qualified project managers are your primary contact point; they are responsible for project initiation, continued management of your PV needs and will anticipate potential future needs.
- Pharmacovigilance in clinical trials and post marketing surveillance
- Specialized solutions for established PV departments
- Risk management consultancy
- IT infrastructure and safety database
Clinical Trials and Post Marketing
The monitoring of clinical trial safety and the continuing post marketing safety are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and expert knowledge is needed to fulfill the stringent obligations. Ethicare’s Pharmacovigilance team is comprised of healthcare professionals with vast experience in both direct patient care and industry-specific pharmacovigilance services, which enables us to provide you with the highest quality safety surveillance services.
Clinical Trial Safety
- Serious adverse event (SAE) management including collection, documentation, active query process and follow-up
- SAE processing within required timeframes in a database available at our collaborative partner and other non-commercial
- Qualified medical review of all SAEs for data completeness and medical senses
- Appropriate Medical Dictionary for Regulatory Activities (MedDRA) coding
- Regulatory reporting to authorities, investigators and ethics committees
- Electronic safety reporting according to ICH E2B
- Preparation and submission of annual safety reports (ASRs)
- Data reconciliation of pharmacovigilance and clinical trials databases
- Writing of patient safety narratives for study reports
- Compliance monitoring
Post Marketing Safety
- Processing and reporting of adverse drug reactions (ADRs)
- Electronic safety reporting according to ICH E2
- Compliance monitoring
- Preparation of periodic safety update reports (PSURs)
- Evaluation of signals with respect to the need to update the Company Core Safety Information (CCSI)
- Periodic signal detection activities for medicinal products with a marketing authorization
- Literature review in collaboration with a dedicated literature service provider