“If it’s not documented, it didn’t happen.” This is a well known saying to Quality teams in biotechnology. What it means is that every step in the development, clinical, and manufacturing processes needs to be documented or else regulators can’t accept that it happened. In the eyes of the FDA, without documentation, the research, the clinical trials, or the manufacturing process needs to be repeated. This results in added expense, costly delays, and an erosion in trust from regulators, investors, and consumers. In this piece, Egnyte chronicles the nine elements that successful Quality & Compliance teams adopt to keep pace with the speed of discovery. Learn the best practices for an effective quality documentation process.
FSP Outsourcing in Clinical Research: Trends and Opportunities
June 9th 2025When 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.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging 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