Drug Safety and Pharmacovigilance

SIRO offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and drug safety officer (DSO) activities. Depending on the contractual obligations, the staff at SIRO may take over a part or the complete responsibility for any medical or safety related issues.

• Patient safety is our prime concern
• Experienced physicians on board

The medical affairs team is comprised of physicians and pharmacists with many years of medical and pharmacovigilance experience and detailed knowledge in various therapeutic areas. By this we ensure that key requirements within clinical trials are managed in line with regulatory demands. For pharmacovigilance this includes not only the expedited reporting of suspected unexpected serious adverse reactions (SUSAR) but also the appropriate handling of serious adverse events (SAE) and unexpected adverse event information. On demand SIRO can provide 24X7 back up to investigators during conduct of trials.

Medical advice

The medical advisor will conduct, support and review the development of all documents required within a clinical trial (e.g. protocol, informed consent, CRF) and prepare for approval by the sponsor. The medical advisor will assist the study team with all medical issues before, during and after the conduct of the study.

Safety monitoring

The drug safety officer (DSO) is responsible for the review of all study related documents and the detailed safety review of all incoming CRFs within 24 hours after receipt (or at least on the next working day in the case of weekends). Previously not recognised or not appropriately reported SAEs or unexpected adverse events must be notified to the sponsor within 24 hours and documented on an initial SAE report form. If data are incomplete or inconsistent, the DSO may contact the investigator directly for clarification of those issues and document this in an SAE follow-up report.

Pharmacovigilance

Within the scope of contracted services the pharmacovigilance team at SIRO is competent to monitor safety and efficacy of investigational medicinal products and marketed drugs, to meet reporting obligations in line with worldwide regulatory requirements and thus contributing to the ongoing risk-benefit assessment.

Our services are offered across all phases of clinical development, ensuring safety, and risk management throughout clinical development and post-approval. Our expert advisory services help sponsors identify and manage post-marketing setbacks that can threaten both product revenues and reputation.

Offering this service we are able to support pharmaceutical companies within specific functions; this service may be particularly useful for companies without a dedicated pharmacovigilance department, looking for a tailor-made and cost effective solution for pharmacovigilance tasks.

Tasks handled by our pharmacovigilance team include

• Set up and maintenance of a global safety database
• Receiving, processing and archiving adverse events/reaction information
• Medical assessment of individual cases
• Contribution to risk signal detection
• Risk management strategy
• Ensure compliance with local and international requirements
• Safety reporting to health authorities and other parties
• MedDRA coding and coding convention strategies
• Medical support for SAE reconciliation
• Preparation of written pharmacovigilance procedures (SOPs)
• Preparation of SAE case narratives
• Interim safety reports (on demand)
• Annual safety reports
• Periodic safety update reports (PSUR)