Risked-Based TMF Quality Review: A Success Story
A biopharmaceutical company had acquired a promising compound with data from 14 clinical trials, including a critical phase III study. Only later did they discover that the Trial Master File documents were scattered across hundreds of boxes of paper and several hard drives. The company was facing critical submission deadlines and the risk of losing financial incentives related to the product acquisition – with zero insight into potential TMF quality and completeness issues that could lead to a failed inspection and delayed submission. Read the case study, “From Liability to Asset: A TMF Rescue” to discover how Phlexglobal’s unique blend of TMF expertise and services turned a “black box” into an inspection-ready TMF – ahead of schedule.
A Guide to Patient Engagement & Recruitment Solutions
March 18th 2025Clinical trials have become increasingly complex over the past decades, making participant recruitment more challenging than ever. This guide explores common recruitment obstacles and offers strategies to overcome them using a patient engagement and recruitment solution.
Merits of a Multifaceted Approach to Clinical Trial Recruitment
March 18th 2025According to a 2024 study “Benchmarking Site Activation and Patient Enrollment,” 33% of sites under-enrolled, and 14% failed to enroll a single patient. The best way to course-correct this is to adopt a multifaceted approach to patient recruitment, that goes beyond traditional channels and ways of thinking.
Citeline Patient Engagement & Recruitment Solutions
March 18th 2025Watch Citeline’s 15-minute presentation from Clinical Leader’s Patient Engagement & Recruitment Solutions Expo, where VP Matt Holms explores Direct-to-Data (DTD) patient recruitment. This session takes a deep dive into how complex algorithms, tokenized data, and large data assets can optimize enrollment, highlighting the importance of early strategic recruitment planning and breaking down the unique benefits and real-world applications of DTD.
