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.

The pandemic disrupted many areas of life, including clinical trials. Many trials stopped or were disrupted, patient participation dropped, and FDA regulations continue to evolve. But this disruption also allowed for adoption of new standards and methods for clinical development, such as virtualization. Throughout the pandemic, moving towards virtualization allowed for clinical trials to progress with fewer interruptions, ongoing participation and robust data. As virtualization becomes critical, this discussion will focus on how clinical trials can adapt to changing needs in order to progress.

In the pandemic we rushed to implement point solutions.  Now we are able to be more strategic, but with so many options and technologies, deciding when and how to apply DCT solutions can be challenging. This presentation will provide insights to help you and decipher what changes may be needed at an organizational level to ensure success.

Covid-19 has played an extreme catalyst role in implementing existing digital and remote clinical trial solutions, and has been the engine behind rapid evolution of a few new capabilities. Some of these newly deployed capabilities are quick fixes for the emergency that COVID brought to our day to day trial operations, while many will benefit from the catalyst effect and will probably be the new standard even after COVID. 

William Shakespeare wrote "All the World's a Stage" - and it is upon that stage that all of global pharma is wanting to perform their version of a decentralized trial.  This session will pull back the curtain and share the backstage reality of a real-life troupe of players working on their planning, execution, and risk management of a decentralized trial.

This session will review the use of in-home trial services that bring the study to the patient. A case study/example of how this is executed with a real-life study will be shared, along with the importance of this service being the standard for many studies.

COVID-19 interrupted clinical trials globally and presented our industry with the challenge of continuing clinical research while ensuring patient safety and data integrity.  Cerevel Therapeutics analyzed ongoing trials to identify risks and implemented innovative solutions to meet those challenges, collaborating with a wide range of service providers to create a hybrid approach which supports patient needs, data requirements and site operations.   

The Decentralized Trials & Research Alliance enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.

This past year has led to buzzword overload! In this session, we will cut through the buzzwords and learn about the realities of eSource/direct data capture (DDC) and how the use of this approach, although not new, can be applied to your clinical trial challenges that have become more prominent in our COVID world. 

Armed with laptops, VPN's, tokens, and a million different end points to log in to, clinical trials have gone digital forcing us to become more creative in how we manage technology; a necessary evil in decentralizing our trials.  As we adapt to the new norm, let's talk about some strategies to eliminate the noise of technology.

Today’s decentralized and virtual trials require a shift to direct-to-patient (DTP) distribution to keep trials moving forward. Join us to explore opportunities to optimize a supply chain strategy that accommodates both direct-to-site and direct-to-patient services utilizing a global Good Manufacturing Practices (GMP) depot network along with DTP and direct-from-patient (DFP) services

The Janssen Global Development Feasibility team has built a sustainable global model to support every trial with data science and technology at an industrial scale. This presentation will focus on briefly showcasing several tools and algorithms that were built internally to bring unfathomable value and data-driven solutions to trial teams that aids them in making solid decisions on how to operationalize each trial for ultimate success and decreased patient and site burden.