Clinipace buys regulatory affairs unit
Regulus will maintain its 10 strong staff at its headquarters in Boulder, Colorado and will operate as Clinipace’s regulatory affairs, strategic development and quality assurance (QA) division.
Specific services will include consultation on filings in both the US and Europe, guidance on packaging and labelling submissions and advice on audits, inspections and remediation plans.
Clinipace CEO Jeff Williams said: “[Regulus] provide a unique resource of experience and skills to meet the requirements of our biopharmaceutical and medical device clients.”
The acquisition, which will also expand Clinipace’s in-house publishing and medical writing business, is the second the biotechnology and medical device focused CRO has made since it was founded six years ago.
The previous purchase, of MidWest clinical trial management consultancy Worldwide Clinical Research, (WWCR), was also made as part of the Clinipace business expansion strategy.
Expansion
The Regulus deal also fits with wider expansion plans Clinipace detailed in an interview with Outsouring-Pharma.com earlier this year after the firm signed up 12 new clients.
Spokesman Dave Levin said that, in 2010, the firm hired additional employees in its data management, clinical operations, software and sales divisions and added that the firm plans to increase its workforce by “30-50 per cent throughout 2011.
Outlook positive
He went on to say that Clinipace is optimistic about 2011, as the conduct of clinical trials for the pharma and biotech segment remains a fast growing market.
“With big pharma divesting research and development (R&D) and partnering with smaller, earlier stage firms, we see more opportunity to serve these firms,”said Levin. “Our service delivery and infrastructure is very well suited to support this strategic shift.”
The dCRO claims to have seen a rebound in new clinical trial starts in 2010 after a minor dip in 2009. Based on such improvements, the firm expects to see growth in new client starts this year among emerging and mid-tier firms.
This year, Clinipace plans to expand its oncology, CNS and immunology drug trials, while continuing to invest in services to medical device firms.
