eClinical creeps across the globe

By Kirsty Barnes

- Last updated on GMT

Related tags: Clinical trials, Clinical trial

It has been another few weeks of activity for the budding eClinical
industry as sponsors across the globe continue to move away from
paper toward electronic reporting in clinical trials.

This week UK firm Datatrak saw the sixth company this year advance beyond the trial stage and choose them as an eClinical provider. Datatrak said that the UK's Medical Research Network (MRN), which offers a "unique" portfolio of clinical trials services, including the ability to provide home based trial drug administration and data capture, has selected the company's eClinical suite as its preferred method of clinical trial data collection. The software provider said it has now been awarded the first of a number of clinical trials that are expected to emerge from MRN's pipeline. According to the firm, the selection of Datatrak eClinical over other technologies was related to the "intuitive user interface and the broad capability offering of the unified eClinical platform, which requires no costly or time-consuming integration steps with other disparate functionalities that might be required in clinical trials."​ Commenting on the decision, Paul Bodfish, head of data management at MRN said: "Fast access to accurate trial data is more important to the wider study team when it is not generated in a hospital environment.""As such, it was essential that we identified an electronic data capture product capable of collecting data in-line with our current technology and processes – Datatrak eClinical provides that platform and gives full flexibility to both our research teams and the sponsor."​ In the US, etrials Worldwide recently announced that it secured $2m (€1.6m) worth of contracts last month, which helped offset contract cancellations of $672,000, and was also named on Deloitte's Technology Fast 500 List. The contracts include agreement extensions with three current customers, including the expansion of a "very large study with a top 10 global pharmaceutical company,"​ who will use etrials' integrated voice response (IVR) systems at 25 sites with approximately 100,000 subjects. The firm said it has also added a new medical device company to its customer-base, who will deploy its electronic data capture (EDC) solution and represents its first eClinical trial implementation to including sites in the US. Meanwhile, over the last few weeks US-based Medidata has been making impressive inroads into the untapped Japanese clinical trials market. Japan's Astellas Pharma has chosen the firm's Rave 5.5 system as its standard global solution for all clinical studies in Phases I-III over the next five years. "Due to Medidata's global reach, comprehensive support services and unique product scalability, Astellas plans to implement clinical trials using Medidata Rave 5.5 across North America, Asia, Europe and other regions,"​ said a company statement. Rave 5.5 particularly appealed to Astellas because it has a Double Data Entry (DDE) feature that will allow it to collect both paper and electronic data in a single database, said Mitsutoshi Mukai, vice president of data science at Astellas. In addition it also contains a functionality that can handle the 20,000-plus unique characters in the kanji language and will "eliminate costly and time-consuming translation procedures.""Unlike other platforms, Rave allows users to work in their native language against a single, global, centrally-managed repository of clinical data without requiring the installation of unique language software versions,"​ said Medidata. It is for primarily this reason that Medidata recently also attracted its 's first customer in the Japanese market, Daiichi Pharmaceutical. Daiichi had been trialling the system on six of its clinical trials, including a Phase II, 500-patient, 60-site study for a cardiovascular drug and has just announced its plans to continue to use Rave 5.5 for additional Phase I, Phase II and Phase III studies in other therapeutic areas. "We've seen EDC deployment in Japan growing in recent months, and with Medidata Solutions' increasing presence and support services within our region, combined with their ability to effectively communicate with clients around the globe, we expect continued success from our partnership with Medidata Solutions,"​ said Daiichi Pharmaceutical spokesperson Mikio Mori. Mori said he anticipates that Daiichi will continue to see significant clinical development cost reductions through the use of Medidata Rave for data entry, data management and programming.

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