Remote eTMF Access to Double in 2015
Veeva Systems announced updated results of a large TMF survey
Veeva Systems announced updated results of a large TMF survey released at DIA, revealing an increase in the number of clinical trial sponsors that plan to provide auditors with remote access to their electronic trial master file (eTMF). More than 32% of TMF owners surveyed in the Veeva 2014 Paperless TMF Survey: An Industry Benchmark report they will grant auditors remote access to their eTMF by early 2015, versus the 16% who provide them access today – a jump of 100%. An additional 12% of survey respondents indicate they will give remote access to their eTMF ‘as soon as they have the technology to support it.’ These survey findings come just months after the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidelines on TMF accessibility.
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.
