OpenClinica ink Athena deal to distribute clinical trial software in China

By Natalie Morrison

- Last updated on GMT

Related tags Clinicaltrials.gov Food and drug administration Clinical trial China

Open source clinical trial software company OpenClinica has launched a marketing agreement with Athena Healthcare Consultancy to work within the Chinese market.

As per the deal, Shanghai-based Athena will gain exclusive distribution rights to OpenClinica’s Enterprise edition of its software, used for data control in clinical trials.

Similar to those offered by Google Android, Firefox, or Facebook, the Massachusetts-based firm’s software license allows people to freely review, modify, and distribute an application's underlying source code.

Company co-founder and director of business development Ben Baumann told Outsourcing-Pharma that he believes it is the unique nature of the software that will bring China’s clinical trials up to the same standard as those in the US.

He said: “Our commercial open source business model is unique. The open source technology is made fully available for companies to use and modify, and as a company we provide sale support for that technology.

“I think the Chinese market is a bit different. There is a lot of activity in the life sciences in China, but the standards of clinical trials there are not necessarily on par with the US FDA’s standards in terms of data security, and the programming used to track trials.

“We hope to help put in place a lot of the necessary structure for China to be a Kosher place to conduct clinical trials.”

Moving on up

The new deal marks the first time Open Clinica – who operate within 70 countries – has established solid routes in China.

When asked why the firm has not formed stronger ties before now, Cal Collins, CEO open clinica, told Outosurcing-Pharma: “We had been more broadly growing in China through other companies, and we have had activity in China for a while now.

“But we realised that having a partner on the ground there was really beneficial for fast growth.

“We are now pursuing a particular strategic focus on China.”

He added: “The new partnership with Athena will provide us with the ground training, study assistance, local support services and localization strategy needed to succeed within the market.

“It provides us with an opportunity to grow in the China market and to help solutions to have trials in that region. It’s not available in that market at the moment.”

And when asked which companies the new alliance has attracted, Collins added: “There are conversations ongoing with a number of firms, and we will be working with a number of companies this year.

“We can’t name any at this point, but we want to work with as many CROs as makes sense.”

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