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.
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.
About Soterius
Disclaimer
Copyright 2025 by Soterius, Inc. All rights reserved. Soterius logo are trademarks or registered trademarks of Soterius in all jurisdictions. Other marks may be trademarks or registered trademarks of their respective owners. The information you see, hear or read on the pages within this presentation, as well as the presentation’s form and substance, are subject to copyright protection. In no event, may you use, distribute, copy, reproduce, modify, distort, or transmit the information or any of its elements, such as text, images or concepts, without the prior written permission of Soterius. No license or right pertaining to any of these trademarks shall be granted without the written permission of Soterius (and any of its global offices and/or affiliates). Soterius reserves the right to legally enforce any infringement of its intellectual property, copyright and trademark rights.
Any content presented herewith should only be considered for general informational purposes and should not be considered as specific to the requirements of any particular organisation or for any specific purpose. Soterius, including its authors, presenters, and any affiliated individuals, does not make any representations or warranties about the completeness, reliability, appropriateness, relevance, or accuracy of the content presented here.
Please consult your physician/Health Care Provider for any matters related to health. No one should act on this information without specific professional advise.