Generation of high-quality biomarker data for a clinical trial requires more than selecting a lab and assay and transferring the data. It requires careful selection and qualification of the lab, fit-for-purpose assay validation, and ongoing oversight of analysis and data. Aligning expectations and building a collaborative relationship between the sponsor and the lab is the key to success.

The pandemic had immediate repercussions across the R&D value chain - particularly on clinical trials. While organizations scrambled to mitigate its impact, notably by adding new sites, COVID-19 appeared to have amplified deeper issues woven within design and enrolment. To consolidate R&D models in the face of uncertainty, organizations could turn to collaboration, genomics RWE insights and innovative decentralized approaches. Discover our analysis and solutions to withstand future disruptions.

When facing a global pandemic, we needed to rapidly develop scenarios and generate risk assessments and strategies to serve our subjects and patients under care in our clinical trials.  Understanding the relationship between global trial sites and Covid-19 hotspots allowed us to focus our resources in critical regions and on specific issues that had the potential to affect our ability to provide continuous support to our participants and sites worldwide.  

Biomarker testing generates more data at all phases of drug development, requiring better analytics within and across trials. Without integrated data, important milestones may be missed, decisions may be delayed and insights may go unrecognized. However, integrating data creates challenges for reconciling the data. Having confidence in the data with robust extraction, load and transform (ELT) tools and predictive system analytics to forecast, monitor and mitigate is the key to success.

Modern biomarker-centric programs demand a focused strategy to provide timely visibility into sample collection, processing, and storage status. Dr. Tobi Guennel will share how clinical teams are leveraging technology to quickly and efficiently gain visibility into their clinical samples across sites, labs, and storage facilities. 

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.

We focus on, for example: genomic technologies, informed consent and ethics, global regulations and policy, innovative clinical trial design, genomic sample collection and use, pharmacogenomic biomarkers, patient stratification, pharmacogenomic education, and regulatory use of genomic data to support drug label statements.

The life science industry has potentially missed opportunities to advance scientific research and benefit public health due to the difficulty of interpreting legislation concerning data privacy and contradictory guidance and opinions from competent authorities. To help navigate the uncertainty this has had for reuse of clinical data, TransCelerate has developed a model framework for secondary research based on personal data. This session will introduce the framework and present its main elements.

The Industry Pharmacogenomics Working Group (I-PWG), established in 2000, is a voluntary association of pharmaceutical/biotech companies engaging pre-competitively to address emerging issues related to pharmacogenomics in drug development. In September 2020, the Regulatory Task Force conducted a survey to assess how the 2019 Human Genetics Resource law in China impacted the conduct of trials prior to and after implementation.

An interactive visual analytics platform will be presented that enables exploratory analysis of biomarker data with clinical subject characteristics and outcomes. The on-demand platform is customized based on the therapeutic area, clinical trial, and molecular data sources with summary and drill-down capabilities.

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.