eClinical news in brief

By Phil Taylor

- Last updated on GMT

Related tags: Clinical trial provides its periodic round-up of developments in the eClinical space, including a tough decision for Datatrak, news of a new contract for Medidata , a recruitment package from HMS and cardiac data certification for specialty CRO Clinilabs.

Datatrak may sell up

US eClinical specialist Datatrak is considering a sale of its business or a merger with another company as it copes with mounting losses. The company has retained Healthcare Growth Partners as a strategic and financial advisor to help it explore its options.

In particular, HGP will help us investigate and determine the value large healthcare technology or other clinical trials-related companies might see in Datatrak​,” said CEO Jeffrey Green.

Datatrak’s revenues slumped 40 per cent in the first quarter of the year to a little over $2m, while net loss came in at $2.2m, up 16 per cent on the same period of 2007 but ameliorated by a 30 per cent reduction in costs. The company recently closed down an office in Bonn, Germany, and laid off around 50 staff across the organisation.

Taiho chooses Medidata

Taiho Pharmaceutical Co of Japan has said it will implement Medidata Solutions’ Rave product as its electronic data capture (EDC), management and reporting solution of choice. Taiho plans to use Medidata Rave to help it carry out a Phase III trial for cervical cancer therapy in Japan, Taiwan and South Korea.

In Japan, ... clinical activity is expanding rapidly and sponsors continue to make investments in clinical technology​," said Tarek Sherif, CEO of Medidata Solutions.

Taiho said it selected Medidata Rave due to the company’s impressive operational results in global, large-scale clinical trials as well as Medidata’s partnerships with leading CROs worldwide, specifically in Taiwan and South Korea. One of the key factors in the selection was that a number of CROs which partner with Medidata also work with Taiho.

Because these partners are familiar with the Rave EDC system, outsourcing studies to these CROs will enable faster study starts, smooth implementations, easier data transfer and compatibility during trials​,” said the Japanese firm.

Find investigators fast with HMS

Health Market Science has launched Clinical Investigators, a new web-based database designed to make it easier for clinical recruiters to sign up investigators to their trials. The company claims the product reduces the time needed by pharmaceutical companies and CROs to recruit physicians for clinical trials by providing instant online access to one of the industry's most comprehensive, up-to-date national databases of physician reference data, clinical trial experience, and claims volume rankings.

With more than 80 per cent of clinical trials experiencing delays, the industry is looking for insight into how trial site selection can become a more effective, efficient and repeatable process​," according to Zach Henderson, vice president, marketing and product development at HMS.

"Clinical Investigators allows users to immediately begin their planning for site recruitment, or aid them in the implementation of an effective rescue plan to get their trial back on target, as well as reduce additional costs and time delays​,” he added.

The package consists of an intuitive web-based user interface with HMS’ national database of more than 4.5 million investigators and 1 million healthcare organisations.

Clinilabs certified for ECG data

Specialty CRO Clinilabs has been named a Certified Partner by Mortara Instrument, one of the leading companies specialising in the manufacture of electrocardiographic equipment.

The certification recognises that Clinilabs’ ECG data meets standards (HL7) requirements, which is critical for sharing the data between the central laboratory and trial sponsor, as well as between sponsor and regulatory authority. The process involves validation testing of sample annotated ECG files, followed by detailed consultation on potential syntax and format errors.

Clinilabs’ ECG Core Laboratory and integrated cardiac safety unit provide support ECG and thorough QT (TQT) studies, operating to the standard required for upload of datasets into Mortara’s ECG Warehouse. Developed in association with the US Food and Drug Administration, the ECG Warehouse is a tool for uploading annotated ECGs to the agency.

"As a Mortara-certified ECG Core Laboratory, Clinilabs is poised to provide sponsors with the same world-class quality in ECG data management that both large pharmaceutical and biotechnology companies have grown accustomed to receiving from us as a core lab in the CNS arena since 2002​," said Gary Zammit, Clinilabs' president and CEO.

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