- Development of study-specific Safety Management Plans
- Handling and assessment of safety case reports (AEs, SAEs, AESIs, special situations, SUSARs, PQCs and pregnancies) incl. related query management
- Timely transmission of safety reports to sponsors and regulatory authorities (EudraVigilance reporting for SUSARs and BfArM reporting for SADEs)
- Tracking of acknowledgements
- Regular reconciliations between safety databases and clinical data
- Medical coding of adverse events, medical history or medications using standardized dictionaries (e.g. MedDRA, WHODrug Global)
- Generation and provision of safety line listings
Patient Safety
Our workflows are designed to detect, document, and escalate safety events quickly and responsibly.
Case Management
All safety cases follow harmonized SOPs and are processed in validated environments—ensuring audit readiness and compliance.
Integrated System
Tight collaboration with clinical and data teams allows seamless exchange of safety-relevant information.
Compliance
We ensure that timelines, formats, and transmission rules meet international and national regulatory requirements.
From Safety Plan to Final Report—Structure You Can Trust
- Each study starts with a safety management plan tailored to the project’s scope and risk profile. Alcedis PV specialists define responsibilities, timelines, communication channels, and reporting pathways—providing the foundation for reliable, study-specific safety reporting.
- Throughout the study, we manage incoming case reports, document each step, and ensure all required parties are informed promptly.
High standards for high responsibility.
Pharmacovigilance demands precision, compliance, and responsiveness. Here’s how we make it work:
- Efficient Case Handling: From intake to transmission, every safety case is documented, tracked, and archived in accordance with applicable guidelines—minimizing risk and duplication.
- Reconciliation Made Easy: We align safety data with clinical records on an ongoing basis, reducing discrepancies and supporting clean data at lock.
- Accurate Medical Coding: Using standard dictionaries like MedDRA, WHODrug Global, NCI CTCAE and ICD, our experts ensure consistent and compliant coding—critical for meaningful safety analysis and reporting.
Latest Whitepaper
Our summarization of EUCROF's propositions on leveraging remote source data verification and reviews (rSDV/rSDR) in clinical trials. Gain insights and recommendations for seamless integration, ensuring data consistency and participant privacy while reducing site burden.
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