Best Practices for 21 CFR Part 11 and GxP Validation for Electronic Records

When drug developers choose the right outsourcing strategies in clinical research, they can gain significant benefits in terms of quality, efficiency, and operational success. In its third annual Functional Service Provider (FSP) Trends Report, Thermo Fisher Scientific’s clinical research business—PPD—gathered insights from 150 global biotech and pharma leaders to determine how FSP models help sponsors address common industry obstacles.

Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access

We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data — and there are more data modalities — to draw from for biomedical research than ever before. However, the quantity, variance and speed of data generation outpaces researchers’ ability to effectively utilize it to reveal medical breakthroughs for those in need. The ability to analyze health data is critical in developing a precision health approach. By leveraging diverse data sources, researchers can determine the most effective actions for individuals and communities. However, current barriers to data access and collaboration hinder progress. To accelerate the pace of discovery, a solution is needed to close the gap between research and health care. This paper describes how Verily Workbench provides solutions for healthcare professionals and researchers to easily access and collaborate on data within an integrated analysis and governance framework. Workbench provides a community of researchers with the platform, data, and tools to solve the most pressing scientific challenge

Learn how Quest can help connect highly qualified patients to a clinical trial with precision identification and direct to patient outreach