Datatrial and TRI announce tech tie up
The clinical trials industry is going through the biggest regulatory change in two decades, forcing companies that run trials to adopt a data driven approach and focus more on quality risk management.
Dr Emma Banks, CEO of Datatrial said: “We are delighted to announce Datatrial’s technology partnership with TRI. We are experts in clinical data collection and stewardship; TRI are experts in quality risk management and regulatory application. By joining forces, we have a far more valuable and united approach to data collection, validation and trial management.”
New regulatory guidance introduced in 2017 has or will be adopted by all major regulatory agencies worldwide by 2018.
As a result, new technology and business practices will have to be adopted by all companies that run trials, driving a greater dependency on data and content in a way most companies are unprepared for and creating a need for new technology, services and training.
Datatrial develop software to improve the clinical research process and recently launched software ‘Nucleus’ in the US and Europe - the company’s first new product launch in 9 years following on from its leading clinical trial software nowEDC.
“We carefully selected a technology partner to enhance our software suite by looking for a best of breed risk management solution through TRI’s software platform OPRA, rather than developing it all ourselves for Nucleus.”
Duncan Hall, CEO of TRI added: “I think there is enormous value created through our partnership. TRI has repeatedly developed and sold technology and services solutions that are proven in the market. Neither company is deficient without the other but we are much more powerful delivered together.
“OPRA enables companies to meet the regulatory guidance and prove that they have done so, as well as allowing the adoption of a risk-based or adaptive monitoring strategy. Non-compliance can mean delays in approvals, portions of clinical trials having to be re-run or potentially non-approval. Risk-based monitoring can potentially reduce the cost of monitoring by 25%.
Emma added: “TRI have a similar vision to Datatrial around visualisation and enhanced decision making, so it is a natural progression for us to integrate the data from nowEDC (clinical trial data) with OPRA. We can then deliver both solutions to our customers via our new collaboration platform, Nucleus.
“Seamlessly delivering OPRA and Nucleus together will put Datatrial and TRI in a strong position to provide a streamlined approach to data collection and risk assessment for clinical and bioscience clients.”
TRI, a specialist solution provider, was formed in 2014 with the sole purpose of developing a total solution to enable companies to respond effectively to the regulatory changes affecting the clinical trial and life science industries. OPRA is a cloud-based, purpose-built operational platform which allows study teams to identify, manage and report on study site quality risk.
Datatrial was founded in 1999 to develop software to improve the clinical research process. Soon after, the company successfully expanded its offering with services geared toward helping customers run clinical trials more efficiently and more cost effectively. Earlier this year Datatrial sold its data service division to a US-based company to allow it to focus solely on software development and new products.