CRF Health is First to Gain FDA Registration, and 21CFR 820 Recognition, of their TrialMaxR ePRO System as Medical Device
In accordance with the new FDA regulation, set in April this year, CRF Health’s TrialMax® has become the first ePRO system to complete its Medical Device registration, a regulation that concerns medical device data systems (MDDS) that collect information from apparatus such as spirometers and glucometers.
TrialMax® is categorized as a Class 1 MDDS under regulation 21CFR 880.6310 (code OUG). And because it uses alarms to remind subjects when to take their study medication, it’s also classified as a ‘medication reminder’ under regulation 21CFR 890.5050 (code NXQ). This makes TrialMax® exempt from pre-market review but still subject to medical device 21CFR 820 quality standards, a practice to which CRF Health is fully compliant.
Rachael King, CEO explains, “CRF Health improves data collection by removing the barriers between intimate patient experiences and the technology designed to capture them.”
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
