PV Solutions provide a full range of PharmacoVigilance (PV) services that offers a cost-effective solution to maintain the PV function without the cost of in-house staff and resources. PV Solutions backed by quality approach and flexibility, assures efficacy while delivering services.

PV Solutions uses the quality assured and 21 CFR Part 11 solution for collecting, storing, maintaining, retrieving and managing Adverse Event (AE) Data. Also generates various regulatory reports.
 

In a nutshell, PV Solutions provide following PharmacoVigilance Services:

• Adverse Event (AE) Data Collection:

  • Adverse Event, Serious Adverse Event (SAE) data collection and analysis

  • Literature monitoring

  • Periodic Summary Upate Report (PSUR) writing

• Data Management:

  • Adverse Drug Reaction (ADR) case processing

  • Searching, monitoring and tracking of Adverse Events

  • MedDRA, WhoDD coding Available

  • PharmacoVigilance Database

  • XML (E2B) submissions available

• Regulatory Reporting (Electronic reporting):

  • Council for International Organizations of Medical Sciences (CIOMS)

  • PSUR

  • Individual Case Safety Report (ICSR)/Anonymised Single Patient Report (ASPR)

  • Line Listing

Why Choose us?

• Medical & Regulatory Expertise

• EU Qualified Person Services

• Huge pool of experience with studies aimed at submission to different agencies

  • 24/7 Medical and Safety Cover

  • SAE/ADR: Receipt and Triage, Data-Entry, Narrative Writing, Medical Review including Label Assessment, Causality Statement, Quality Control, Submission to Health Authorities

• Validated drug safety database

• Signal detection and evaluation

• Trained and experienced staff

Contact us at:
Unit 4, Appley court, Appley Wood Corner, Haynes, Bedford MK45 3QQ