Virtify launches on-line data disclosure solution

The software automates all workflow and data gathering in clinical trials, capturing the information in the format required by the appropriate regulator in an approach that, Virtify believes, reduces the time it takes to put submissions together.

A company spokesman told Outsourcing-pharma that increasing disclosure and transparency requirements from regulators worldwide had driven the development of the online version of Virtx clinical trial results and registry (CTRR) solution.

“Regulatory bodies and international health organizations necessitate that all companies performing clinical trials provide increased transparency and disclosure of clinical trial procedures, results and, soon, adverse events.​

Despite this, he continued, “many life sciences companies are scrambling to fully understand and comply with these requirements,” adding that “They are not sure how to ensure compliance from country to country and state to state.”​

Non-compliance can have a significant financial impact on drugmakers in terms of launch delays and lost market opportunity, particularly the types of small and midsized companies for which Virtx CTRR was developed.

The system is updated in real-time when new rules are announced. The spokesman explained that: “Virtify tracks these evolving regulations and restrictions closely and is an active member in many of the standards bodies worldwide.​

Data disclosure market ​

Traditionally, pharmaceutical firms have taken one of two approaches to the problem of trial disclosure and management. The first option is to license individual solutions for each reporting process required during the trial.

Although using dedicated software for each process can be effective, the lack of cross software integration can throw up a variety of non-trial related problems such as, for example, data formatting issues that could delay submission.

The second common approach taken to data disclosure is to use a non-specific content management system which, while undoubtedly effective in some applications, may lack the specific functionality required to manage some aspects of the trial process.

In contrast, Virtify believes the hybrid approach offered by Virtx CTRR is something different.

“The Virtx platform is purpose built for life sciences companies and regulated content submissions. Virtify has then built specific functionality and solutions for each of the different regulatory processes life sciences companies have to manage​.”