Almac partners to offer ePRO

09-Dec-2009 - Last updated on 09-Dec-2009 at 10:49 GMT

Almac has entered into a partnership with FACIT.org to gain PRO and QoL assessments which it believes will help it recruit patients and generate high quality data for regulatory submissions.

Use of electronic patient reported outcomes (ePRO) has been slowly increasing over the past decade and this, coupled to the wide use of quality of life (QoL) assessments in cancer trials, has led to Almac partnering with FACIT.org (functional assessment of chronic illness therapy).

Under the terms of the deal Almac Clinical Technologies will deliver FACIT.org’s PRO and QoL assessments using its IXR platform, which integrates various user interfaces in the collection and processing of clinical trial data.

By using its IXR platform Almac believes it can “significantly broaden” the patient populations reached by the assessments. Patients will be able to access the questionnaires in a variety of ways, including phones, the internet and handheld devices.

Almac will also utilise the translation services provided by FACIT.org, which has offered the more than 40 questionnaires it has developed into over 45 languages.

The questionnaires developed by FACIT.org include functional assessment of cancer therapy-general (FACT-G). This has been used in 100s of clinical trials for oncology and other therapy areas and indications.

FACT-G, now in its fourth version, is compilation of questions divided up into four QoL sections: physical well-being; social/family well-being; emotional well-being; and functional well-being. Although developed for cancer it has been applied to other chronic illnesses, including HIV.

Joseph Bedford, director of marketing at Almac Clinical Technologies, added: “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.”