Pharmacovigilance for Decentralized Clinical Trials

Decentralised clinical trials make clinical trials easier for patients by reducing the need to travel to clinical sites. They are also known as “Direct-to-participant trials” or “virtual” studies.

DCTs are highly technology driven that often require the use of the following:

Depending upon the clinical trial design and practicality, DCTs may be:

Challenges posed by multiple data systems and processing teams

Challenges in consolidation of data at the time of document preparation.

Reconciliation of data can potentially take longer.

Submission delays.

Inspections & Audits become more complex.

Vendor management is complex and more expensive.

Partner Notifications/Exchange of Information, additional tracked activities.

Requirements of the Centralized Safety System

Technical Agreement

Safety Management Plans

Central SOPs with Work Instructions

Site Communication Protocol

Safety Database + Processes

Compliance and Governance

Validated Safety Database System

EDC <> Safety Data Exchange

Secure Notifications to Sites

Follow Ups and Site Queries Tracking Tools

Literature Management Tools

Signal and Trending Tools, Volume Dependent

AI Based Tools to process large volumes of data

Data Migration Tools to support product transfers, etc.

References

  1. European Medicines Agency: Guideline on good pharmacovigilance practices (GVP) Module VI – Collection,
    management and submission of reports of suspected adverse reactions to medicinal products (Rev 2);
    Dated 28 July 2017.
  2. European Medicines Agency: Detailed guide regarding the monitoring of medical literature and the entry of
    relevant information into the EudraVigilance database by the European Medicines Agency; Dated 12 May 2015
  3. European Medicines Agency: Monitoring of medical literature and the entry of relevant information into the
    EudraVigilance database by the European Medicines Agency; Description of the Journal/Reference databases
    used; Dated 21 December 2016

Author

Dr. Parul Singla - Sr. Director, PV Operations

Parul is an M.D. in Pharmacology with over 15 years of experience in pharmacovigilance and clinical research. He has managed
the expectations of multiple clients on quality and compliance for complex analytical work in medical safety such as signal
management, risk management, aggregate report preparation, and on the immediate impact case management functions.
He has participated in over 10 regulatory inspections with successful outcomes. Parul has experience across pre and postmarketing
pharmacovigilance including signal management, aggregate report, ICSR case processing, SAE/ SUSAR processing and
reporting, analysis of similar events, safety management plans, SAE reconciliation plan, etc. In his previous role, he headed the
pharmacovigilance department of a global pharmaceutical company where he successfully accomplished global harmonization
of the pharmacovigilance function to create a Centre of Excellence.

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