Clinical research news in brief
pharmafile | November 30, 2009 | News story | Research and Development | CRO, Clinipace, ICON, Parexel
Pharmafocus’ latest round-up of clinical research news includes a new US registry to aid patient recruitment, alliances for ICON, Parexel and TNO and Clinipace’s acquisition of Worldwide Clinical.
Ireland’s ICON plc has signed an extension to its strategic agreement with Eli Lilly to handle the drugmaker’s clinical data management outside the US. Last November, Lilly tapped ICON for its expertise in clinical data management outside the US and Japan, part of a major drive by the drug major towards greater use of outsourcing across its R&D functions. The latest extension means the Irish CRO will now also manage Lilly’s needs in Japan, in addition to those in Europe, Canada, Latin America, Australia and Asia. In June, Lilly also selected ICON to manage clinical trial site set up and monitoring in Europe.
The US National Institutes of Health has set up a national patient recruitment registry to connect clinical trial volunteers with study sponsors. The database – called ResearchMatch.org – is the first of its type in the US, according to the agency. “Participant recruitment continues to be a significant barrier to the completion of research studies nationwide,” said National Centre for Research Resources (NCRR) Director Barbara Alving. “Recent NIH data indicates that just 4% of the US population has participated in clinical trials,” she added.
Clinipace has acquired fellow US contract research organisation Worldwide Clinical Research in a deal which creates a company with 30 employees and sites in the US, Brazil, Argentina and Peru. The company has changed its name to Clinipace Worldwide and specialises in cancer trials, among other therapeutic areas. Chief exeuctive Jeff Williams said the deal expands Clinipace’s focus on electronic data management services with additional clinical expertise and capacity. Terms of the acquisition were not disclosed.
Parexel has boosted its ability to carry out cardiac safety studies via an alliance with Mortara Instrument, a manufacturer of electrocardiogram (ECG) devices. The CRO will make use of Mortara’s wireless Surveyor Telemetry Central System to carry out continuous, diagnostic ECG monitoring in early-phase studies. The system has been installed in Parexel’s clinical unit in Baltimore, Maryland, USA.
US CRO Seventh Wave is planning to purchase two gastrointestinal modelling systems from Dutch company TNO and will use them to help its clients test the behaviour of their drug candidates as they pass through the GI tract. The TIM systems are used to analyse the release, solubility and absorption of orally-administered pharmaceuticals. Seventh Wave expects to have the two systems ready for use by customers in the first quarter of 2010.
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