Steven Sulkin, CEO, SimuLyve International

Marina Ziehn, PhD, Global Med. Affairs Dir. Neuroscience, Novartis

Markus Krüer, PhD, Head Clinical Project Mgt, Merz

Nico Wegener, PhD, Senior Clinical Project Mgr, Merz

Dave Matthews, Clinical Project Dir., Merz

Training worldwide staff on complicated protocols virtually with the added issue of language barriers can seem daunting. Our panel of virtual experts will show you how to perfect virtual skills and enhance virtual meetings.

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.

COVID has rapidly accelerated the need for effective capabilities and  procedures to enable remote participation in clinical trials.  It's also accelerated the need to develop ways to ensure our medicines make it to the patients whom need them.  This presentation will cover methods  and mechanisms available to maintain trial and therapy continuity in the time of COVID, and during any crisis the clinical trial supply chain may face.

For 40 years investigational drug has been manufactured, packaged and labeled according to GMP requirements which are 100% product-focused to ensure quality and safety of the drug.  With COVID-19, the acceleration of DCTs and DtP shipping we must now follow state pharmacy dispensing regulations which are 100% patient-focused and ensures quality and safety for the patient, finally solving many of the past and current clinical supply chain problems.

We’re creating a new model for virtual trials and direct-to-patient medication delivery using techniques we’ve perfected over the last 10+ years in our commercial specialty pharmacy operation. This session will review the hurdles, learnings, and success stories from our journey. Everything the FDA requires, alongside what the state boards of pharmacy require, delivering a better patient experience at a lower cost.

Getting medications to patients is what local, independent pharmacies are experts at.  Newdays pharmacy is positioned to easily serve as a regional central-fill pharmacy hub to dispense Investigational Medicinal Product throughout the UK and into Europe through its current prescription dispensing and direct-to-patient platform.

Sylvain will present recent examples of how lockdowns, travel restrictions, and depot closures impact trial supply management and how robust processes and proven IRT technology can address these and other challenges to ensure you get products get to patients, no matter what, so they can be treated safely and on time.

As the global pandemic took hold, eConsent quickly became one of the most important clinical technologies in the industry. Learn the benefits and challenges of implementations on a global scale in unprecedented timeframes:

• Case studies where remote consent enabled rapid start-up and enrollment without sacrificing compliance
• Collaboration experience and lessons learned in the rapidly evolving pandemic environment where protocols and country/site selection are continually shifting, and 
• Changing regulatory landscape enabling adoption