Freyr Pharmacolvigilance Brochure
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Freyr provides pharmacovigilance solutions and services including case management, medical review, safety reporting, literature screening, and signal detection. They offer end-to-end pharmacovigilance processes from data collection through reporting to regulatory authorities. Freyr prides itself on quality, reliability, and regulatory compliance with over 99% adherence to deadlines and improved accuracy rates through lean processes.
Freyr Pharmacolvigilance Brochure
- 2. Freyr Pharmacovigilance Solutions and Services Freyr provides end-to-end solutions for your pharmacovigilance nedds We offer a comprehensive set of functional capbilites in a Global Delivery Model
- 3. Overview Supported by our acquired expertise and domain knowledge, Freyr offers extensive Pharmacovigilance Services that help cement your Pharmacovigilance Processes by enhanc- ing process efficiency and reducing cost pres- sures - 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 Pharmacovigi- lance 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 rates that are delivered by adhering to lean Six Sigma processes - delivering increased case handling per person per day. Freyr Pharmacovigilance Services MEDICAL/SAFETY LITERATURE SERVICES
- 4. Freyr Pharmacovigilance Services Portfolio 1 2 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 Periodic search and review on: Articles Manuscripts Abstracts Excerpts Bibliographic Searches for (ICSR) Medical/ Safety Literature Services
- 5. Freyr Pharmacovigilance Services Portfolio 3 4 Global Aggregate Report Development Signal Detection & Analysis 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 Risk management associated reports Signal Generation and Detection Signal Analysis Determination of causality Evaluation of frequency & strength 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 We provide a Tier based approach in Signal Detection:
- 6. Copyright © 2013 Freyrinc contactus@freyrinc.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 Disclaimer : All content / information present here is correct at the time of publishing and may be company sensitive, proprietary, or otherwise protected from disclosure and is intended only for informational purposes. The document should not be disclosed, disseminated, or redistributed and may not be used for any commercial purposes without authorized consent through prior written permission from Freyr Inc. Unauthorized use of the content / information appearing here may violate copyright, trademark and otherapplicable laws, and could result in criminal or civil penalties.