Pharmacovigilance
Offers comprehensive global services in a budget-friendly approach
MEDKINE serves as a reliable global partner in drug safety and pharmacovigilance, delivering safety services to biopharmaceutical companies for drugs, devices, vaccines/biologics, and cosmetic products. We offer a comprehensive range of services for managing adverse events, SUSARs, ICSRs, CIOMS, MedWatch, and other regulatory formats arising from clinical trials and post-marketing surveillance. Our expert global safety team operates following the drug safety procedures established by pharmaceutical companies to ensure compliance with regulatory standards. At MEDKINE, case management processes adhere to proprietary methodologies developed by our skilled QA professionals. We implement systematic procedures that allow us to streamline tasks with detailed workflows, enabling us to deliver high-quality results and effective services at competitive prices. As a provider of drug safety services, MEDKINE is dedicated to fulfilling all your pharmacovigilance needs during both the clinical phase and post-marketing phase.
Individual Case Safety Report (ICSR) Processing
- Management of both serious and non-serious reports from various sources.
- Intake -> Assessment and triage -> Data input -> MedDRA coding -> Writing narratives -> Medical evaluation -> Quality assessment -> Ready for submission -> Submission to FDA with systematic tracking, version control, and follow-ups.
Adverse Events (AE) Case Management
- AEs are handled for incidents that come from various origins.
- AEs are filtered from unsolicited reports during post-marketing surveillance, case reports from clinical trials, and searches in published literature.
- Metrics, dashboard reports, and visual representations of data.
Aggregate Reports- Prepare and Publish
Our specialized team in medical and regulatory writing creates:
- Periodic safety documentation for international regulatory bodies – PADER, PSUR/PBRER
- Providing writing assistance for ASR/DSUR
- Offering medical review support for aggregate reports prepared by other vendors
- Ad hoc and/or Addendum reports
- Summary Bridging Reports (SBRs)
- Drug Safety Reports (DSRs)
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
Signal Detection
Signal Detection is a nuanced field within pharmacovigilance services that demands a significant level of expertise. At MEDKINE, we skillfully tackle this challenge. We methodically and accurately monitor and document all notable medical events that indicate a need for medical intervention. Our PRR Statistical process encompasses:
- Assessment Approach – Regular and proactive AE data exploration
- Screening, recognising, and classifying
- Verification and Validation
- Monitoring and Trending
- Evaluation
- Event Ranking
- Searching and comparing external data
- Evaluation and reporting
- Suggesting actions
Risk Management Plans-Write/Update/Maintain
Our skilled medical professionals possess extensive experience in creating
- REMS – Risk Evaluation and Mitigation Strategies (for the US FDA)
- RMP – Risk Management Plan (for the EU)
Literature Searches
We offer comprehensive literature search services utilizing public and commercial databases such as AdisInsight, Embase, Medline, and PubMed for the identification of adverse events and the creation of aggregate reports.
Additional Pharmacovigilance Outsourcing Services encompass:
- Creation of Standard Operating Procedures (SOPs)
- We assist in formulating SOPs associated with pharmacovigilance processes.
- Procedures for case processing
- Procedures for aggregate reporting
- Updating and maintaining SOPs
Digital Pharmacovigilance
With the introduction of advanced technology designed to eliminate manual data entry mistakes and expedite decision-making, we are in the midst of refining and upgrading our systems to automate safety data entries from all available safety data formats into our databases. We collaborate with top industry PVAI specialists to ensure that safety data is captured accurately and in a natural manner for improved decision-making. As a result, we deliver precise, real-time, high-quality data entries for subsequent assessments and decision processes.
Our team comprises PVAI specialists, programmers, clinical data management professionals, healthcare experts, drug safety specialists, aggregate reporting scientists, and medical affairs staff, all operating from our headquarters in Princeton, New Jersey, as well as utilizing global delivery centers in Europe and India.