Almac Releases ePRO Data
Almac announced the results of a survey conducted by researchers at the Tufts Center for the Study of Drug Development.
Almac Group, a global provider of technology and services for the pharmaceutical and biotech industries announced the results of a survey conducted by researchers at the Tufts Center for the Study of Drug Development, which was backed by a grant from Almac. The survey found that sponsor and CRO companies are receptive to, and plan to increase their use of ePRO. The results revealed that the top benefits of ePRO adoption are increased data quality, patient compliance, and efficiency of data collection.
The results of the survey, http://www.almacgroup.com/wp-content/uploads/Tufts-CSDD-Study-of-ePRO-Usage-in-Clinical-Trials.pdf based on 22 responses from 18 companies, also show that the adoption rate of ePRO will continue to rise, as it is still a relatively new addition to clinical research programs. More than two-fifths (61%) of respondents indicated their companies began using ePRO in the last five years, while 11% have been using ePRO for more than 10 years. In examining future trends, more than three-quarters of respondents expected that there would be increasing ePRO usage for post-marketing trials for primary and secondary endpoints.
Read the full release here.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
