Site selection in any clinical trial is arguably one of the most important, if not THE MOST IMPORTANT, start up activity.  What are the buzzwords sponsors should look for when selecting sites for their studies? We will explore methods that can be employed to discern which sites will be successful and which won't and what questions should be asked and how should they be answered to ensure site success. 

A successful partnership between sponsor and sites is critical to the execution of a clinical study. Navigating the complexity of study designs, assessing the volume and method of data being collected, the increasing number of studies competing in the same space and with the implementation of considerations for COVID, now more than ever we need a mutual understanding of what is required and what can reasonably be done.

This presentation discusses key elements required in developing a high quality clinical investigational plan (or protocol) to collect data on a medical device.  Whether your device is a new concept or already commercialized, any new study needs to weigh the risks to the patient participants against the potential benefits the results from the study may yield.  The protocol is the roadmap defining the steps required to conduct a successful study.

Lessons learnt from the first IVDR certification projects will be discussed and put into perspective with regard to expected time and resource constraints. An update will be given on the latest developments of guidance documents and their implications for manufacturers.

The European Medical Device Regulation 2017/745 (MDR) has been postponed by one year due to the COVID-19 pandemic and is now expected to be operational on May 26, 2021. The majority of medical devices already on the market have obtained the necessary approval by a notified body under the Medical Device Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD). Both directives will be repealed by the MDR. The number of notified bodies designated under the MDR is only a small fraction of the previous number, so there is extremely limited capacity for the necessary maintenance of issued CE marks. There is a severe lack of capacity for re-certification of products prior to the May 25, 2021 deadline, since notified bodies are currently focused on the renewal of certifications that have expired during the COVID-19 pandemic. Certifications for new medical devices will depend on the end of the pandemic and associated travel restrictions for on-site audits. Despite the recent regulation and rulings, numerous significant questions and legal gaps remain.

Over the course of the past year, several Notified Bodies have conducted audits as well as reviews of manufacturers’ Technical Documentation according to the new Regulation (EU) 2017/745. Although we will see more MDR-designated Notified Bodies, stakeholders can learn from experiences  under the MDR, so far. This session provides insights into the lessons learned from the past months from the perspective of Notified Body TUV SUD.

Overview of the Clinical Trial Solutions at Tempus which support precision patient identification and recruitment for oncology clinical trials through the TIME Trial program, a rapid activation Just-in-Time network of research-experienced clinical trial sites

Watch a live demonstration of protocol design utilizing real-world data on the TriNetX platform for a phase III cardiovascular randomized controlled trial, and a subsequent label expansion.

Clinical trial planning is one of the most complex and difficult aspects of the clinical trial process, with multiple factors impacting enrollment. Inaccurate forecasting can lead to misallocation of resources and downstream bottlenecks. How can we use the data we have to do a better job of predicting enrollment?

This case study will share the strategy behind the building of an enrollment modelling tool, detailing each step throughout the process.  Gain lessons from AbbVie’s experience building and implementing the tool, steps taken to improve its predictive power and accuracy, and results to date.

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.

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.