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Patient-facing digital technologies are playing an increasingly important role in clinical trials, to the point where including virtual components in trials has become mainstream. But terms like remote, site-less, hybrid, and decentralized trials have added ambiguity and confusion to this new virtual ecosystem. Where exactly does the industry stand on terms like "virtual" or "decentralized" trials?
Advancements in technology have enabled virtual visits and remote patient monitoring and have provided new options for data collection. This has forged the path for hybrid and decentralized clinical trials. These new approaches improve patient experience, data quality, and expedite the clinical trial process. Studies are more accessible and convenient for patients. Investigators gain valuable patient insights, and sponsors get answers to their scientific questions faster.
However, moving in this direction requires change. Trying to incorporate new world innovations into a traditional protocol design and operational practices doesn’t fit. It’s not enough to choose a patient-facing technology, the entire data flow needs to be optimized. Consider the effect on data quality, healthcare professional workflow, patient ability to comply, and feasibility of conducting a trial across geographies.
The hesitancy to change is understandable given the potential impact on an organization. A deep understanding of what constitutes a hybrid or decentralized clinical trial is necessary in order to effectively determine if a shift is the right move.
Jeyaseelan Jeyaraj
Senior Director, Health Sciences, Oracle Corporation | President, HIMSS India
Jeyaseelan Jeyaraj (Jey) is a recognized Healthcare Informatics Leader on addressing the challenges facing the global healthcare industry and prospects for improving patient outcomes through better use of healthcare data and information. Jey brings his 20 plus years of broad consulting experience in Healthcare & Pharmaceutical R&D that spans venture-funded biotech, large pharma, CRO and Healthcare Providers. He has published several papers and articles on e-health technologies. Jey is a Senior Director in the Health Sciences Global Business Unit at Oracle Corporation and also serving as President of HIMSS India a leading global healthcare Think Tank. Jey has completed Post Graduate Program in Management from University of California (ULCA) Anderson School of Management.
Syed Firasatullah
Senior Solutions Consultant, Health Sciences, Oracle Corporation.
Syed Firasatullah is Senior Solutions Consultant at Oracle Corporation. Syed has over 12 years of experience in the pharmaceutical industry, specialized in Clinical Research and Pharmacovigilance. He has worked as a Drug Safety Associate, in the pharmacovigilance department at a global CRO. He then worked in clinical operations as a Clinical Research Associate on many global clinical trials. He has also worked at a leading global Pharma as a remote monitor and assisted in the development and implementation of central remote monitoring process for their global clinical operations.
As a Senior Solutions Consultant, his interest is to develop relationships and to engage with customers by uncovering the business challenges faced in the pharmaceutical research industry and providing a meaningful perspective in the use of Oracle Health Sciences suite of products. Syed holds a Master’s Degree in Pharmacy from Rajiv Gandhi University of Health Sciences in India.
