Best Practices for an Effective Quality Documentation Process
“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.
Optimizing Phase III Oncology Trial Recruitment with Data-Driven Insights
February 3rd 2025A pharmaceutical company aimed to launch a Phase III clinical trial for a new oncology drug, focusing on efficient and effective patient recruitment across diverse regions. They evaluated patient populations by analyzing demographics, social determinants of health, and geography. Investigator profiling included practice details, affiliations, referral networks, and clinical trial experience. The final step involved selecting and extracting target lists for implementation.
Data-Driven Insights can Optimize Clinical Trial Site Selection
February 3rd 2025Clinical trials are crucial for drug development but often face delays due to poor site selection, which can lead to protocol violations, poor data quality, and increased costs. Ninety percent of clinical trials fail to meet their timelines, and issues like inadequate staffing and patient recruitment are significant challenges. Traditional site selection methods are inefficient, and the COVID-19 pandemic has further complicated the process. Data-driven insights can optimize site selection by evaluating current data on patient populations, investigators, and site capabilities.
