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.

This talk presents the enterprise efforts in AstraZeneca to deploy RWD/RWE capabilities for clinical research innovations across broad therapeutic areas, with a focus to communicate our best practice, areas of success and challenges yet to conquer. We will share our strategy, pilot cases, steps of implementation and key learnings.

 From billions of data points gathered through health care of patients, we can generate a wealth of insights into how patients are managed for acute and chronic conditions in the real world. At PRA, we leverage data to understand the patient journey and apply those insights to design clinical trials and bring new treatment options to the patients that need them most. We leverage real world data for protocol evaluation, finding eligible patient populations, outreach to diverse patients, and assessment of trial enrichment strategies.

Real-World Data (RWD) is playing a critical role in accelerating research and development, especially in chronic and autoimmune diseases. This session addresses:

• Data networks and technologies for RWE applications
• RWD utility across R&D
• Novel uses for Artificial Intelligence (AI) in R&D
• Case examples including Rheumatoid Arthritis, Lupus, Multiple Sclerosis, and Heart Failure  

A design framework of synthetic control arm creation using RWD with real examples which support clinical development of a broad Oncology portfolio. This overview will highlight key principles in targeting trials to design adequate synthetic controls and showcase examples of internal synthetic arms used for decision making and external methodologies taken from the planning phase of future trials.

During this presentation, we will share insights regarding differences in informed consent document read times, video watch times and knowledge check scores among different populations, such as diagnosis group, age, and race. There will also be discussion regarding the relationship between engagement during the eConsent process and clinical trial completion as well as insights into the quality and compliance benefits of eConsent. Recommendations will be presented to enhance the eConsent process, such as ways to ensure the eConsent is engaging based on the population being worked with.

Patients are becoming “point of care” in clinical development and healthcare, empowered by integrated and continuous support. If a patient’s status and experience can be tracked continuously for self-monitoring and communication with physicians and other stakeholders, patients could be better informed and motivated. Some severe consequences may be avoided by discerning in advance of significant change in patterns. This presentation will explore innovative approaches (digital bot, wearable, etc.) to assist patients in continuous tracking and integrated support in a cohort of patients living with a chronic condition.

Real-world data (RWD) are those data collected outside conventional randomized clinical trials to evaluate what is happening in the real world environment. While the focus of evidence generation using RWD has traditionally been on clinical endpoints (i.e. safety and effectiveness outcomes), in order to provide a more holistic view of the experience of disease and well-being there is a need for RWD that captures the patient lived experience. Novel sources of data from clinical practice, social media, patient reported outcomes, and wearable devices are part of the RWD ecosystem and contextualizing real-world data within the pharmaceutical industry will be critical to ensure the data is fit for regulatory decision making. It is critical to incorporate and contextualize the patient perspective into real-world evidence strategies for regulatory decision making. This session strategizes how to better contextualize (i.e. linkage across data types, social, behavioral, and spatial contexts of RWD) the patient perspective within RWD utilizing concepts and methodologies from the social/behavioral sciences.

TransCelerate’s solutions help identify ways intelligent automation technologies can support and improve the execution of pharmacovigilance (PV) activities and processes. Using the Individual Case Safety Reporting (ICSR) process as a case study, we will introduce foundational terminology, attitudes toward intelligent automation, applicable technologies, and validation considerations.

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.