Analysis Proves Positive for RBM
Medidata announced positive results of a data-driven analysis conducted in collaboration with TransCelerate BioPharma
Medidata, a global provider of cloud-based solutions for clinical research in life sciences, announced positive results of a data-driven analysis conducted in collaboration with TransCelerate BioPharma, which assesses the value of source document verification (SDV) in a risk-based approach to clinical trial site monitoring.
Using robust operational data available through the Medidata Clinical Cloud®, the joint analysis explored the relative contribution of SDV—the process by which data within a case report form (CRF or electronic CRF) is compared to the original source of information—to overall clinical data quality. Results of the analysis revealed that only 1.1% of total site-entered eCRF data are corrected as a result of SDV, confirming that SDV has a minimal impact on overall data quality. Additionally, when compared to SDV, the analysis showed that central monitoring activities and source data review (SDR)—a process that involves checking the quality of the source data, reviewing protocol compliance and ensuring critical processes and source documentation are adequate—are of relatively higher overall value, supporting the conclusion that SDV should not be the primary data quality control method used in clinical trials.
The analysis was published by DIA's Therapeutic Innovation and Regulatory Science journal.
Read the full release here.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
