SIRO offers a comprehensive range of medical and pharmacovigilance services
essential for the conduct of clinicaltrials
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
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 backup to investigators during conduct of trials.
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. We make surereporting obligations are in line withworldwide regulatory
requirements and thus contribute to the ongoing risk-benefit assessment.
Our services are offered across all phases of clinical development. They ensure safetyand risk management throughout clinical
development and post-approval. Our expert advisory services help sponsors identify and manage post-marketing setbacks that
threaten both product revenues and reputation.
By offering this service, we are able to support pharmaceutical companies within specific functions. Our pharmacovigilance
service is particularly useful for companies without a dedicated pharmacovigilance department that are looking for specific,
cost-effective solutions for pharmacovigilance tasks.
Tasks handled by our pharmacovigilance team include:
- Setup and maintenance of global safety databases
- Receiving, processing and archiving adverse events and 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)
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
for all medical issues before, during, and after the conduct of the study.
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
recognized or not appropriately reported Serious Adverse Events or Unexpected Adverse Events must be notified to the sponsor
within 24 hours and documented on an initial SAE report form. If data is incomplete or inconsistent, the DSO may contact the
investigator directly for clarification of those issues and document this in an SAE follow-up report.
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