How to Reinvent and Scale Decentralized Clinical Trials

Life Sciences, Clinical Trials, Patient Recruitment & Retention, Drug Discovery & Development, Medical Device,
  • Wednesday, September 22, 2021

The adoption of decentralized clinical trials (DCTs) has increased over the past 18 months due to the COVID-19 pandemic. The digitization of clinical trials has revealed numerous benefits to both study sponsors and patients, including streamlining of clinical operations, reducing patient and investigator burden, accelerating clinical trial timelines, and increasing patient diversity, compliance and retention. With the advantages of DCTs so apparent, studies are left looking for new ways to capture medical-grade data remotely and securely.

The key to a successful DCT is a superior patient experience, as it directly impacts compliance and retention. In this webinar, AliveCor will deliver real-world examples of DCTs, showing how implementing user-friendly digital health devices improves overall patient experience while simultaneously providing study sites with easily accessible, medical-grade, health data.

Speakers

http://Craig%20H.%20Lipset,%20Clinical%20Innovation%20Partners

Craig H. Lipset, Founder, Clinical Innovation Partners

Craig Lipset is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions and patient engagement. He is co-chair for the Decentralized Trials & Research Alliance, serves on the Board of Directors for the Foundation for Sarcoidosis Research (Vice President) and the MedStar Health Research Institute (Vice Chair), as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science.

Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma. Craig has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials and the AlleyWatch Who’s Who in eHealth.

Message Presenter
http://Dr.%20Todd%20Rudo,%20ERT

Dr. Todd Rudo, Deputy Chief Medical Officer at ERT

Todd Rudo, M.D. is the Deputy Chief Medical Officer at ERT, with board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. He completed his general medical training at Jefferson Medical College in Philadelphia, PA, and specialty training at Lankenau Medical Center in Wynnewood, PA. After transitioning from clinical practice, Dr. Rudo has focused his career on drug safety and pharmacovigilance with experience across multiple therapeutic areas within large and mid-size pharma.

In his current role with ERT, he primarily serves in a consultative capacity, advising sponsors on optimal cardiac safety strategy, protocol design, regulatory considerations, statistical analysis, and expert report generation. Additionally, he provides oversight to ERT’s ECG/Holter core lab, and leadership of the biostatistics and medical writing groups.

Message Presenter
http://Aman%20H.Bhatti,%20MD,%20AliveCor%20BioPharma

Aman H.Bhatti, MD, Vice President of Global Medical Affairs & Head of BioPharma, AliveCor

Dr. Aman Bhatti is currently the Global Head of AliveCor BioPharma, the group at AliveCor specializing in strategic partnerships with CROs and biopharmaceutical companies to enable decentralized clinical trials, create drugs and beyond-the-pill solutions, develop new cardiac algorithms, and to enable convenient cardiac safety monitoring both in-office and in the patient’s home. Dr. Bhatti is a physician, digital health futurist, and pharmaceutical executive focused on developing revolutionary technologies to increase healthcare accessibility, predict disease onset, prevent disease progression, and improve health outcomes worldwide. He is a firm believer in a holistic digital healthcare practice that offers patients products and services that go beyond just treating their disease and symptoms.

Prior to joining AliveCor, Dr. Bhatti had over a decade of experience as a global medical & innovation leader for major household healthcare brands including Mucinex, Theraflu, Flonase, Nicorette, Allegra and Nasacort at leading pharmaceutical companies including Reckitt Benckiser, Novartis, GSK, and Sanofi.

Message Presenter

Who Should Attend?

  • Clinical Operations
  • Clinical Trial Organizer
  • Clinical Research Organization
  • Head of Clinical Research
  • Clinical Development
  • Study/Project Manager
  • Protocol Manager
  • Pharmaceutical Companies
  • Academic Research Organization

What You Will Learn

In this webinar, participants will learn about:

  • How to improve the participant experience in DCTs
  • Challenges faced by researchers to capture quality patient data during decentralized clinical trials
  • The importance of form factor when determining which tools to implement for studies  

Xtalks Partner

AliveCor, Inc

AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS and Normal Heart Rhythm in an ECG. Kardia is the first AI-enabled platform to aid patients and clinicians in the early detection of atrial fibrillation, the most common arrhythmia and one associated with a highly elevated risk of stroke. AliveCor’s enterprise platform allows third party providers to manage their patients’ and customers’ heart conditions simply and profitably using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices, achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. For more information, visit alivecor.com.

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