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Validity : 01st Aug'25 to 11th Aug'25
Clinical Research Ethics in Decentralized Trials (DCTs)
- Managing consent
- Clinical trial monitoring
- Protocol deviations in virtual settings
Overview of the webinar
- Decentralized Trials (DCTs) are reshaping the clinical research landscape by enabling patient participation beyond traditional research sites. Leveraging digital technologies, remote monitoring, and virtual interactions, DCTs increase accessibility, reduce patient burden, and accelerate study timelines. However, these advantages come with complex ethical considerations that differ significantly from conventional trials.
- This session explores the core ethical challenges unique to DCTs, including ensuring informed consent in a remote setting, safeguarding patient privacy and data security, maintaining equitable access for diverse populations, and addressing potential risks associated with limited in-person oversight. The reliance on digital tools necessitates new approaches to verify participant identity, monitor safety, and manage adverse events responsibly.
- Participants will gain insights into evolving regulatory expectations, ethical frameworks, and best practices for designing and conducting DCTs that prioritize participant rights and welfare
- The discussion will also cover the role of Institutional Review Boards (IRBs) or Ethics Committees in overseeing these trials and strategies to foster transparency and trust with patients
- As decentralized trials become a key component of modern clinical research, understanding their ethical dimensions is critical for sponsors, investigators, regulators, and ethics reviewers. This session empowers healthcare professionals and researchers to navigate these challenges effectively, ensuring that innovation in trial design aligns with the highest standards of research integrity and patient-centred care.
Who should attend?
- Clinical Research Manager
- Principal Investigator (PI)
- Clinical Trial Coordinator
- Ethics Committee / Institutional Review Board (IRB) Member
- Regulatory Affairs Specialist
- Clinical Operations Director
- Patient Safety Officer
- Clinical Data Manager
- Medical Monitor
- Quality Assurance Manager – Clinical Research
- Decentralized Trials Program Manager
- Healthcare Compliance Officer
- Clinical Innovation Lead
- Digital Health Project Manager
- Bioethics Consultant
Why should you attend?
- Decentralized trials (DCTs) are transforming clinical research by enabling remote patient participation, improving accessibility, and accelerating study timelines. However, this shift also raises unique ethical challenges -such as informed consent, data privacy, patient safety, and equitable access—that must be thoughtfully addressed
- Whether you are a clinical researcher, trial sponsor, ethics committee member, or healthcare innovator, you will gain essential knowledge on maintaining patient rights and trust in a decentralized setting
- By attending, you’ll learn best practices for ethical oversight, risk management, and regulatory compliance tailored to the remote and technology-driven nature of DCTs
- This insight will help you balance innovation with integrity, ensuring your trials are not only efficient but also ethically sound and patient-centred
- Stay ahead in the evolving clinical research landscape by understanding how to uphold the highest ethical standards while leveraging the benefits of decentralized trial designs
Faculty - Dr.Sonali Kirde
Dr. Sonali Kirde is a Medical Doctor and Strategic Consultant with rich experience in the pharmaceutical industry, having held critical roles at Merck Sharp Dohme (MSD), GlaxoSmithKline (GSK), and Takeda Biopharmaceuticals. Her expertise includes clinical pharmacology, regulatory strategy, market access, and medical affairs, driving impactful product launches and healthcare innovations.
As CEO & Founder HealthSpect 360, she support healthtech startups on regulatory, GTM, and investment strategy. She is also the Founder of ELEVATE, where she mentors doctors for leadership roles, exploring non-traditional career opportunities specially in Pharmaceutical companies. She also consults healthtech startups on regulatory, GTM, and investment strategy. In addition, she runs a Podcast Channel- The HealthSpect Show where she share powerful insights, tips, and real conversations—from basics to bold innovations in healthcare and startup ecosystems.
Dr. Sonali is a mentor and judge at top incubators including Startup India's MAARG, BHASKAR, IIT Bombay E-Cell, IIT Madras E-Cell, AIC Pinnacle, WISE SNDT, MSSU I-SPARK, VentureBlick (Singapore), GooCampus, Womennovator, WIMA, and Wadhwani Foundation, and serves as Regional Director for a nonprofit supporting girl child education and women’s empowerment.
As a recognized speaker, she have been invited to share her insights at national and international forums, contributing to discussions on healthcare innovation, patient outcomes, and medical advancement.
As a Consultant to health care startups, she plays a vital role in the growth and success.