Pharmacovigilance Solutions & Services
Freyr provides end-to-end solutions for your pharmacovigilance needs
We offer a comprehensive set of functional capabilities in a Global Delivery Model
Freyr Pharmacovigilance Services Overview Supported by our acquired expertise and domain knowledge, Freyr offers extensive Pharmacovigilance Services that help cement your Pharmacovigilance Processes by enhancing process efficiency and reducing cost pressures - offering value, reliability and ensured regulatory compliance through deployment of dedicated service teams that work towards the unified goal of efficiency enhancement and cost reduction. We offer an array of Pharmacovigilance Services, ranging from collection of data, processing and medical reviews, safety writing, reporting through report writing, along with signal detection and analysis. Freyr works with you via a partnership model, which offers you the advantage of benefiting from our acquired expertise, global reach, quality systems approach, multidisciplinary safety expertise and adhering to reporting timelines of EMEA, FDA, MHRA, and other regulatory authorities.
Assured Quality, Reliability and Compliance Freyr has acquired skills in implementing effective processes and executing robust work-flows, gaining global recognition on the way by providing high-quality Pharmacovigilance Services to Pharmaceutical companies. We provide end-to-end Pharmacovigilance Services across a broad range of Therapeutic Areas spread across all phases of clinical development with a consistent and rigid adherence to delivering high-quality outputs meeting more than 99% compliance with regards to regulatory deadlines, increased reduction in error rate and increased accuracy MEDICAL/SAFETY LITERATURE SERVICES rates that are delivered by adhering to lean Six Sigma processes - delivering increased case handling per person per day.
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Freyr Pharmacovigilance Services Portfolio
Case Management and Medical Review Receive cases from various sources Case Initiation AE Triage Data Entry, MedDRA Coding Adverse Event Labeling Narrative Writing Quality Check
Review source documentation Confirm Seriousness Confirm Expectedness Review & Modify comments Identify SUSAR/SUA’s
Medical/ Safety Literature Services Periodic search and review on: Articles Manuscripts Abstracts Excerpts Bibliographic Searches for (ICSR)
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Freyr Pharmacovigilance Services Portfolio
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Global Aggregate Report Development
Global Periodic Safety Reporting (PSUR, PADER, PBRER) Provide support for ASR/DSUR Review source data Scientific/Medical Assessment of case Medication Error and Drug Abuse/Misuse Reporting Toxicology Report Management Medical writing support for report generation
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Risk management associated reports
Signal Detection & Analysis Signal Generation and Detection Signal Analysis Determination of causality Evaluation of frequency & strength
We provide a Tier based approach in Signal Detection: Tier 1:
Routine proactive signal identification, prioritization, analysis and reporting Tier 2:
On-Demand pro-active signal detection and data mining Tier 3:
Strategic Risk Management Planning
www.freyrpv.com
US : 103 Carnegie Centre, Suite 300, Princeton, NJ - 08540, Phone: +1 908 345 5984 India : 606, Navaketan Complex, S.D. Road, Hyd - 500003, Phone: +91-40-40117020
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