‘Localizing’ Remote Digital Clinical Trials: Ensuring the ‘Patient Connect’

There has been a significant shift in the industry operating model towards hybrid ‘digital’ or ‘virtual’ clinical trials. A diverse spectrum of approaches is being used to accelerate patient recruitment and retention, by ‘localizing’ the trial – bringing it closer to the patient’s home. Can we reduce both the ‘patient burden’, as well as the ‘healthcare burden’, by ‘decentralizing’ clinical trials?

Despite the pharmaceutical industry being highly regulated and a slow adopter of technology, diverse approaches are being used, such as the use of e-consenting tools, social media, a ‘chip in a pill’, wearables and sensors, IOT and a world of ‘connected devices’, telehealth platforms and “virtual exam rooms” and the analysis of sound-bites to diagnose neurological disorders are being used, just to name a few. AI is being utilized to identify mutations in DNA, diagnose genetic disorders and support the development of a ‘precision medicine’ approach. Electronic health records (EHRs) are being mined to identify patients, especially for conditions such as rare diseases. RWD, such as EHRs, claims data, registries, etc. are being analyzed and ‘synthetic control arms’ are being generated to drive go or no-go development decisions. Even clinical trial monitoring is now being centralized, with a focus on predicting risk and integrating quality at the grass-root level.

The healthcare industry continues to struggle with fundamental challenges, in terms of data interoperability, data privacy and data security. Even more fundamental questions that arise include filtering through the data deluge and identifying the right data to be captured and recognizing those key risk indicators that can compromise both the clinical trial and the patient’s life. While the healthcare world is being fueled by data, technology and analytics, we take pride, as an industry, in the fact that we are driving ‘patient-centric’ clinical trials and firmly believe that the newer approaches are more representative of a patient’s real-life experience.

On the other hand however, is the healthcare industry in-fact losing the patient-connect? Are we truly speaking the patient’s language, understanding the patient’s concerns, their local and cultural sensitivities, and ‘translating’ the patient’s needs?

Speakers

Dr. Nimita Limaye

Dr. Nimita Limaye has over two decades of life sciences leadership experience working across global pharma’s, CROs and consulting companies, and has been an entrepreneur, as well as a strategic advisor and mentor for digital-health start-ups in life sciences. She has served as an industry thought leader and has given talks in multiple global forums on this topic and is passionate about how technology has become a game-changer in clinical trials. Dr. Limaye has recently joined CSOFT Health Sciences, Boston as the SVP, Strategic Partnerships & Medical Writing to help grow the regulatory submissions and medical writing business, in addition to supporting the growth of CSOFT’s core business of localization and translation services. She is a strategic business leader with a strong understanding of the drug development industry, with rich cross-cultural experience working across the US, Europe and Asia.

Message Presenter

Ms. Shunee Yee

Ms. Shunee Yee is the Founder and CEO of CSOFT International, a leading global communications and localization company helping multinational pharmaceutical and medical device manufacturers achieve regulatory compliance with the FDA, EMA, NMPA. Responsible for operations at 16 global offices spanning 3 continents, Ms. Yee’s 25+ years of industry experience and leadership have earned her recognition in numerous publications, including Fortune Magazine, Investor’s Business Daily and Forbes Asia. Her contributions in the education sphere include keystone support for cross-cultural programs at the Johns Hopkins US-China Studies Nanjing Center. In June 2016, she led CSOFT into a partnership with the Shenzhen Municipal Government to launch the Shenzhen 100 research report, helping implement policies supporting global market strategy development. The CSOFT Health Sciences branch illustrates Ms. Yee’s passion for improving patient’s lives globally through her expertise in cross-border communication.

Message Presenter