Almac announced a unique partnership with FACIT.org for electronic distribution of the latter’s Patient-Reported-Outcomes (PRO) and Quality of Life (QOL) assessments. The partnership agreement empowers Almac to use and validate leading FACT and FACIT assessments through any and all electronic modalities including phone, web and handheld devices. As part of the agreement, Almac will also leverage the translation services that FACIT.org provides in delivering these instruments to patients worldwide.
FACIT questionnaires, including the notable Functional Assessment of Cancer Therapy-General (FACT-G), have been used in hundreds of clinical trials for oncology and other therapy areas and indications. The FACT-G (now in Version 4) is a compilation of general questions divided into four primary Quality of Life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is used widely with any form of cancer, and has also been applied and validated in other chronic illness conditions, such as HIV/AIDS and multiple sclerosis.
With this new partnership Almac advances its goal of providing pharmaceutical and biotech companies with a world-class solution for Electronic-Patient-Reported-Outcomes (ePRO) using its patented IXR technology. Almac’s IXR platform seamlessly integrates various user interfaces in the collection and processing of clinical trial data. By utilizing its technology to deliver the FACT and FACIT assessments, Almac will broaden the potential populations for these patient assessments.
“Almac understands that two of the greatest challenges in clinical trials are recruiting/retaining patients and generating high quality data for regulatory submission. The FACIT.org partnership helps us address both challenges by giving Almac access to some of the most notable scales used to gather PRO data and collecting it in a secure, user-friendly way that assures data integrity and quality for our clients,” said Dr. Joseph Bedford, Director of Marketing, at Almac Clinical Technologies.
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.