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.

Developing biomarkers is key to delivering medicines that improve patient’s lives. Good biomarkers have the potential to confirm that the compound/study drug affects the intended biological pathway and confirm the mechanism of action and help with dose setting. Novel biomarker assays are developed by the sponsor and transferred to a performing qualified lab to have a fully qualified assay for a global clinical trial. Partnering between the sponsor, the CRO managing the trial, and the central lab to successfully meet timeline deliverables is a well-orchestrated production requiring open communication and flexibility.

Labconnect continues to lead the industry in providing innovative strategies and solutions to the ever growing complexities of clinical trial virtual sample management. The complexities of sample collection and logistics in advanced therapy studies naturally brings chain of custody challenges in protecting the integrity of a trials’ high value samples. Topics will include end to end sample management strategies, logistical integration planning, real-time tracking and LIVE monitoring technologies.

Outsourcing your biospecimens is a major decision but maybe the easiest decision in the whole process. Choosing a company to handle, track, and potentially process invaluable specimens as well as aggregate usable data can be a complicated process. This discussion will outline some of the items a company should consider when using an outside entity to manage biospecimens and their associated consents.

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