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.


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.

About Soterius

Soterius is a strong team of pharma professionals who design customized, innovative, and cost-efficient processes for clinical safety, pharmacovigilance, and medical affairs. Our deep industry knowledge and up to date insights let us combine agile, people powered intelligence in pioneering customer centric solutions. Our innovative technology solutions include engagement tools and communications platforms to create a unified and compliant medical access facility. With a strong global presence, we provide comprehensive clinical and post marketed safety services, that include aggregate report writing, signal detection and management, global literature surveillance, risk management, case processing and regulatory reporting. We use state-of-the-art technologies to solve complex safety operations problems, be it case processing, intake, site reporting for clinical trials, or literature search and management. We have one of the most accurate solutions for case intake and case processing using AI.
We support companies from the initial development stage of a drug/vaccine to the approval and ultimate marketing of the therapy, supporting ongoing operations and regulatory commitments globally.

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