Dec. 2006 / Jan. 2007 | Last month, Medidata Solutions announced that Tokyo-based Astellas Pharma (a joint venture between Yamanouchi and Fujisawa) will use Rave 5.5 for all its global clinical studies over the next five years, representing what Medidata’s founder and chief medical officer Edward Ikeguchi calls a “real effort and commitment to adopt EDC.”
Medidata may have only been in the Japanese market for some 12 months, but Rave has the functionality specifically requested by sponsors there, says Ikeguchi, a dual American and Japanese citizen. EDC adoption in Japan is a mere 1 percent, but not because the business mindset is conservative and risk-averse. “The Japanese approach...is incredibly pragmatic,” says Ikeguchi. They simply want a product they can use, and up to now, there hasn’t been one.
Medidata’s Rave has the ability to handle the 20,000-plus unique characters in the kanji language, and is the only EDC product capable of handling Chinese characters as well (see sidebar). It also accommodates the workflow of Japanese studies, which are intrinsically different from those in the West. For example, clinical research coordinator staff may or may not exist, and “that’s the mission-critical user in the U.S.” Communication with the investigative site also gets multiple levels of review, which, as a matter of respect, involves the use of different linguistic styles.
Saving International Time
Moreover, Japan’s Ministry of Health, Labor and Welfare (MHLW) recently came out with its first-ever guidance on electronic records and electronic signatures, and it’s slightly different from the FDA’s 21 CFR Part 11. Rave is compliant with both.
Formatting is adaptable to whichever agency — the FDA or MHLW — the data is being reported to, says Ikeguchi. Data logged into the system in Japanese can be automatically translated into printable PDF files suitable for submission to the FDA, including an audit trail so translations can be reviewed.
All of this adds up to huge time and cost savings for Western companies doing studies in Japan. “The paper process adds months and months to timelines for clinical trials [in Japan],” Ikeguchi says, “especially if there are hundreds of thousands of CRFs [case report forms] that need to be translated.” Data for concomitant medications or adverse events that get typed into the database have to be mapped to a Japanese coding dictionary and translated into English, along with all freehand text in the CRF.
“At the end of the day, the biggest factor is [Rave’s] appeal to doctors and nurses...the end client,” says Ikeguchi. “We’ve worked with them for a couple of years now and the feedback has had a recurring positive theme.”
Rave gives sponsors homogenous data in a single database and language using single dictionary coding. “If a data manager logs information in New York City, it’s the same system the data manager logs into in Tokyo,” says Ikeguchi. The user is automatically shown the appropriate user interface based upon their preferred local language, much as they would when using Google.
Industry-wide, the trend is for sponsor companies to “go commercial” as their internal homegrown EDC solutions become obsolete, says Ikeguchi. In 2007, he predicts “at least a half dozen” other firms — including mid-size biotechnology companies and mega device manufacturers — will choose a single EDC partner. “Even with smaller companies, there’s now the appearance of trying to standardize on an EDC product.”
Sidebar: The Chinese Way
Another new biopharma customer for Rave is AstraZeneca. “It’s an ideal client ... because [the company] has used EDC internally for years and has good acceptance and adoption of the technology,” says Ikeguchi.
Two years ago, AstraZeneca began moving away from reliance on its homegrown product and selected Medidata as one of two “preferred” commercial EDC vendors. It then compared their performance across studies of all sizes. Neither Medidata nor AstraZeneca would name the other preferred EDC vendor.
Initially, AstraZeneca plans to implement Rave on all phase II-IV global studies, which number about 55, according to Medidata spokesperson Susan Lombardo. “[The company’s] ultimate goal is to use Rave on all studies...within the next several years.”
The decision to go with a sole vendor makes sense to clinical study sponsors from the standpoint of contracting, deployment, and implementation efficiencies, says Ikeguchi. There are also “fairly dramatic differences” between Rave and competing products on the market. “We’re one of few vendors, if not the only one, to have a single source code and platform for data management and EDC. We have also been extremely supportive of all AstraZeneca’s efforts in the Asia-Pacific region.” -- D.B.
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