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 MDR and IVDR oblige companies to continuously collect data about their devices, both prior to the device being placed on the market and afterwards during its entire lifetime. Such data must be used to perform the clinical evaluation of the device and to conduct post-market surveillance. This presentation discusses how manufacturers can use data collected from various sources, including clinical research, to fulfill their legal obligations.

One of the biggest challenges that manufacturers face under the new MDR is the need for additional clinical data.  This presentation will assess the requirements for legacy devices under the MDR, explore available sources of clinical evidence and the role of clinical investigators and registries in gathering evidence.  Also gain insight into the financial burden of gathering clinical evidence for legacy devices, as well as potential opportunities.

This presentation will outline the purpose of pre- and post-market studies and why multiple types are necessary. I will provide a comparison of requirements by study type and share how real-world data and experience (RWD/RWE) could be used in both pre- and post-market studies. This presentation will highlight a case study in embedding post-market studies in national registries.

This topic will focus on how one company developed and implemented a Remote Monitoring Quality Assessment tool and process post COVID-19. The discussion will focus on the process development aspect, why the process was necessary and the determinants/components used for developing the tool.  The discussion will include factors to consider when determining if there is a difference in data quality between remote monitoring and on-site monitoring. 

Surgical clinical trials have unique complex designs, involving new devices and novel non-surgical interventions, as well as stringent eligibility criteria and coordination with routine clinical and operative care. There are many factors such as work-flow, patient consent, strict eligibility criteria, complex investigational devices and intervention, as well as diverse administrative processes and increased regulatory oversight that can limit the success of these trials. Discussion of how these factors have led to success and failures in surgical trials can help to learn what are the key issues  Gain the physician investigator and clinical site perspective on challenges in surgical trials, and how to incorporate site input into the protocol development process, optimize study protocol, build and implement a data-driven site selection approach on a global scale. This will include self-reflection about what factors in past and current trials led to success and failure of the trial at different stages.

Research sites have been faced with adopting new processes and tools across many different sponsors in order to support more virtual ways of working. This session will highlight how to understand the site perspective when implementing remote monitoring solutions. Important site considerations will be shared including the desire to standardize across studies, ways to decrease administrative burden, understanding resource limitations, ways to support more seamless communication between sites and sponsors, and methods for sites to enable a better virtual experience for their research participants.

COVID-19 has created a new sense of urgency for digital transformation with a heightened focus on digital health tools to address patient needs. Digital health is now being applied across the full spectrum of healthcare from wellness & prevention, to diagnosis, treatment, and management of health and disease, and it is being delivered across the healthcare setting from the hospital to home. This presentation will review how digital health technologies can now provide more potential than ever to apply a patient centric approach to healthcare delivery and to the modernization of clinical trials.