AstraZeneca goes paper free
paperless and will exclusively use Medidata to assist in the
process.
The drug giant will now standardise all its studies on Medidata Rave electronic clinical data capture (EDC), management and reporting solution, replacing its in-house EDC system and any other EDC products currently being used. "When implemented, we look forward to achieving significant improvement in clinical efficiency, with the goal of improving overall time to market," said Anders Ekblom, vice president and head of clinical development at AstraZeneca. "AstraZeneca has high expectations for Medidata and Rave." In 2005, AstraZeneca conducted a review of a number of EDC products with a view to replacing its in-house system, which it has used since the early days of EDC technology. The company assessed such features as ease-of-use, product look and feel and cost as well as which ones had the best fit with its strategic process and the functionality required, said an AstraZeneca statement. "Medidata Rave met the highest percentage of AstraZeneca's requirements and was selected for its strong architectural base, new technology, and user-friendly platform." Meanwhile, over the last few weeks US-based Medidata has been making impressive inroads into the untapped Japanese clinical trials market with its EDC technology. 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.
