Medidata and PPD Partner to Offer New Approach to Risk-Based Monitoring
Medidata and PPD announced they are expanding their partnership around risk-based monitoring.
Medidata, a global provider of cloud-based solutions for clinical research in life sciences, and CRO Pharmaceutical Product Development (PPD), announced they are expanding their partnership around risk-based monitoring. This effort combines processes to increase data sampling and tracking of source document verification (SDV) through Medidata TSDV (targeted source document verification) with site health assessments and risk evaluation through PPD’s adaptive and intelligent monitoring. This new endeavor will afford clinical research associates increased scrutiny of targeted endpoints that pose the greatest areas of risk in studies. Through this new arrangement, the companies will track specific SDV requirements and compliance directly within EDC systems and will have greater opportunity to focus remote monitoring on targeted criticaldata points.
Read the full release here.
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.
HHS Cancels Moderna Grant for Late-Stage Development of mRNA Vaccine Candidate
June 4th 2025Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.
