There is a need to move from the current analytical risk based management approaches which includes using descriptive Key Performance and Risk Indicators for many aspects of clinical operation including site risk score to drive site monitoring plans to a more dynamic and predictive approach. This approach requires a data driven assessment of site risks with adaptive and dynamic monitoring plans to ensure focused management of risk including Investigator Site Monitoring and drive efficiencies through a focus on the right activities at the right time, with better workload & capacity planning, increase quality focus through proactive risk mitigation. Also with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, e-source, use of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now.  This presentation explores a novel approach on the use of technology and the future of risk based management of clinical trials.

We apply a common framework to assess the quality of recruitment decisions and identify common issues leading to deviations from plan. Although the recruitment problem can be framed clearly and clinical teams come up with innovative alternatives, recruitment predictions may suffer from lack of relevant insights or plans may not be aligned with operational objectives. Even if we apply a sound rationale to come up with the best plan, we would need commitment from various groups to execute on it. Investigation of the decision quality elements has potential to maximize our learnings from the past.

A clinical data analytics platform can reduce development time and costs by leveraging AI-enabled building blocks to influence business outcomes. In this presentation, IQVIA will share examples of analytics that are generating intelligent insights to improve workflow collaboration; and show how to deploy algorithms in a number of scenarios to better predict and monitor site health.

This talk will give an understanding of different FSP models and how they can evolve within organizations.  It will give this view from the perspective of the supplier and also of the client and make some key recommendation to think about when considering a FSP.

Life sciences organizations looking to transform the patient experience, modernize processes for clinical trial sites, and create other internal and external improvements often run into slow development timelines or solutions that are not sufficiently tailored to their patient population and disease area. Join Kara Dennis, Head of Healthcare at Unqork as she talks about deploying high-fidelity, complex applications in weeks -- all without writing a single line of code.

Ask an R&D IT Colleague, there are never ending projects for Pharmaceutical R&D IT teams to accomplish in any given financial year. So,how do you make sure to address the most important business needs while also addressing the urgent needs? While doing those both, how do you enable innovation and deliver the best outcomes possible for business within a fixed amount of budget ?  Solution lies within how start-ups operate, innovate and build platforms to scale – the much needed shift in paradigm within Pharma R&D IT to bring aspects of Product Management which help deliver & sustain innovation at scale.

This presentation provides an overview of the trends and uses of Data & AI within Clinical by discussing:

• Experiences of and expectations for companies applying AI at scale
• Enablers for achieving business value from BI, analytics and AI solutions
• Hands-on experience across use cases incl. Study and Site feasibility

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.

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.

Traditional Clinical Trial Management Systems (CTMS) are often time consuming and costly implementations and not an ideal fit for many sponsors that outsource their clinical monitoring. As organizations grow and expand their pipeline, creating real-time visibility to trial and site performance versus relying on feeds from partner CTMS systems becomes a higher priority. This talk explores the “right-size” Clinical Trial Management System for growing organizations. What operational data should be owned and managed internally and provides the greatest value and insights.

By integrating centralized data review systems together, AbbVie's clinical data review platform provides a one-stop-shop for all clinical data activities, encompassing study start-up, conduct, and close-out, and resulting in increased efficiency and compliance. This intuitive, robust, and scalable platform enables automation where possible to drive speed, agility, and quality. Utilizing this new platform eliminates the need for manual trackers, closes the gap between plan and execution and further drives team collaboration.

The global pandemic catapulted us ahead of schedule to bring together tested novel solutions that aren’t yet at scale. We are at a critical juncture for disruption with the opportunity to change the clinical trials execution model once and for all. #NoGoingBack

Today, I will discuss how the CONFORM platform can drive clinical data strategy and transform the way we execute Clinical Trials.

An interactive analytics platform will be showcased that provides cross-functional stakeholders direct access to clinical data allowing for easy study monitoring, on-demand insights, and agile decision making. These solutions are deployed for early development Oncology clinical trials to promote rapid and repeatable consumption of the data and enable go/no-go decisions.

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.