Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority
Drug development has never before been so difficult, time consuming and expensive. Accuracy in clinical trials, therefore, is a priority. However, suboptimal adherence is prevalent in ambulatory trials, in which outpatients are responsible for taking the drug according to the protocol-specified dosing regimen. Unfortunately, most methods for measuring medication adherence are inaccurate, which can result in costly phase III failures. This whitepaper focuses on a proven exception-automatic adherence measurement through electronic compilation of drug dosing histories. Electronic measurement enables a better understanding of drug safety and efficacy data, improving the likelihood of a successful trial outcome and more informed development decisions, leading to faster speed to commercialization.
Read more on our whitepaper 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.