Medelis provides a focus on safety to advance global health.
Safety, Support and Regulation Expertise
The rapid growth of the number of clinical studies worldwide, along with their increasing complexity, creates a greater burden on you to keep abreast of changing regulations.
To keep patients safe, rely on our safety expertise, support and monitoring services. Medelis’ pharmacovigilance services team can identify, assess and mitigate your patient safety risks throughout the lifecycle of your product. We work closely with pharmaceutical companies and other CROs to provide support, and expert advice during each phase of drug safety development and analysis process.
Our global pharmacovigilance team understands the local regulations and can assist with the creation of Data Monitoring Committees (DMCs), in-study cohort Safety Review Committees (SRCs) and Independent Data Safety Monitoring Boards (IDSMBs).
Technology + Discipline + Expertise to Keep You Compliant
Leveraging the latest technology and extensive medical evaluation and review, our pharmacovigilance services team understands what data to capture, how to interpret it, and what reports, literature and plans to provide to keep you compliant.
- Medelis’ pharmacovigilance services include:
- 300-person medical call center to handle AEs
- SOP development
- Safety plan development
- Receipt and processing of SAE/SADE and AE/ADE reports
- AE/SAE reconciliation
- Literature review, including periodic line reporting (DSURs, PSURs/PBRERs and PADERs)
- Safety database
- Safety management plan
- Signal detection and analysis
- DMC, SRC, and IDSMB creation and maintenance
- Aggregate analysis and support for safety review committees
- Case narratives
- Expedited reporting (IND safety reports, SUSARs, medical device and post-marketing reports)
- Drug safety reporting to regulatory authorities, EudraVigilance, IRBs/IECs and investigators
- Site, team and reporter training
Our Pharmacovigilance Services Process
- Define the expected adverse events (EAEs) based on preclinical development that should be anticipated in first-in-human (FIH) clinical studies and beyond.
- Design data capture methods for EAEs that can be used to determine
- Scope of adverse event;
- Frequency of adverse event;
- Severity of adverse event; and
- Relatedness of adverse event to study product versus underlying disease.
- Record adverse events in detail, capturing such information as
- Dose, frequency and route of administration;
- Concomitant medications; and
- Underlying conditions and predisposing characteristics of patient populations.
- Establish the Critical Safety Signals for Phase I – IV development and prepare for post-marketing pharmacovigilance as the drug is used in the general population.
- Inform the development of
- Investigators’ brochures for each study;
- IRB packages;
- Product labeling;
- Consumer information; and
- Annual reports.
- Differentiate adverse events in terms of
- Severe adverse events
- Expected versus unexpected
- Reporting requirements
- New-onset chronic illnesses
- Drug interactions
- Severe adverse events
Medelis CRO Services
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