You may be interested in
COVID-19 Vaccination Programs & Implications
Of The Human Microbiome
Our Offerings
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ICSR Case Processing
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Aggregate Reporting
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Literature Surveillance
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Risk Management System
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Signal Management & Analysis
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Medical Information Call Centre
- Case book-in & Triage
- Data Entry
- Narrative Writing
- Quality Review
- Medical Review
- Case Submission
- Periodic Safety Update Reports (PSUR)
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Periodic Adverse Drug Experience Report (PADER)
- Canada Annual Summary Report (CASR)
- Development Safety Update Report (DSUR)
- ACO reports – Addendum to clinical overview
- Global literature monitoring
- Monitoring of the EMA’s Medical Literature Monitoring (MLM) and assessment of safety information
- Literature monitoring to supports the aggregate reports and signal management process
- Risk management system development
- Identification of safety concerns
- Development and Implementation of risk minimization measures
- Assessment of risk minimization measures
- Preparation of RMP update(s) based on change in safety profile of product
- Literature review
- Signal detection
- Signal validation
- Signal confirmation
- Signal analysis and prioritization
- Signal assessment
- Recommendation for action
- Medical Inquiry
- Product quality complaints
- Adverse event reporting
- Query management
- Case follow up
Our Holistic Approch
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PV System setup & Integration
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Expedited & Periodic Safety Reporting
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Safety Surveillance & Risk management activities
- Setting up and hosting of safety database and management
- Legacy Data Migration
- Safety data exchange agreements (Co-licensing, Third party Manufacturer/Distributor, Piggy back ..etc)
- Support with third parties and channel Partners
- Pharmacovigilance consulting involving standard operating procedure (SOP) development, quality systems and strategic consulting
- End to end ICSR case processing including electronic transmission as applicable
- Dedicated clinical trials team with experience processing cases from early dose determination studies to advance phase 3 clinical trials
- Integrated PV and Medical information (MI) response centres
- Medical review case assessment
- Global literature monitoring
- Aggregate report preparation and compilation (PSURs, PBRERs, PADERs, CASRs, DSURs etc)
- End-to-end signal management activities
- Routine risk monitoring activities
- Preparation and review of risk management plan, implementation and strategy including additional risk minimization measures, risk communication and effectiveness assessment
- MAH oversight and support including training, SME review and gap analysis of Risk Management Measures
Advantages
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Experience in managing end-to-end pharmacovigilance services and understanding the challenges faced by small and medium-sized pharmaceutical companies
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Experienced team of subject matter experts (SMEs) and Physicians with extensive therapeutic area expertise and strong medical knowledge
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Wide-ranging experience with multiple regulatory regions
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Robust planning and processes in place to ensure smooth project transitions
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Strong expertise in handling ever-changing regulatory requirements
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Audit ready quality processes, Anytime Inspection Readiness
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Highly adaptable with proven collaboration across the functional areas
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Risk mitigation strategies with strong business continuity plan
ADVITY RESEARCH PRIVATE LIMITED
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