Sankyo Pharma GmbH Simplifying Clinical Trial Communication with IntraLinks
Pharma leader to manage socument flow for ROADMAP trial in more than 22 European countries
London, September 27, 2004
IntraLinks, the leading pharmaceutical industry provider of secure document exchange technology, announced today that Sankyo Pharma GmbH will use its secure online workspaces to manage document flow for its ROADMAP (Randomised Olmesartan And Diabetes MicroAlbuminuria Prevention) clinical trial. This study will involve 22 countries and about 220 centres throughout Western and Eastern Europe, and will recruit more than 4,400 patients. ROADMAP is the first ever large-scale multinational trial to study whether the compound Olmesartan, the latest Angiotensin II Receptor Blocker (ARB), can prevent the onset of microalbuminuria -- an early sign of kidney disease -- in patients with type 2 diabetes.
"By using IntraLinks, we can securely exchange and track confidential documents among the study team members and all constituents involved in the trial, regardless of location," said Dr. Petra Laeis, Director and Head of Clinical Development for Sankyo Pharma. "Using IntraLinks allows us to replace our traditionally paper-based document distribution processes, such as expensive courier services. With this technology we will create a new level of efficiency, allowing us to reduce cycle time and cost while providing better tracking control of documents routed to review committees and trial sites. We are excited about the partnership with IntraLinks."
IntraLinks will enable Sankyo Pharma to substitute traditional paper-based processes such as courier, mail and e-mail with a more secure and efficient online document distribution and collection process. Sankyo will use the technology to share clinical documents with IMFORM, its Contract Research Organization partner. IntraLinks' unique "fax-in" capability will allow trial managers to electronically capture enrollment forms in one central location - an IntraLinks digital workspace. Documents sent via a traditional fax machine directly enter the workspace in digital form. Rather than sending multiple faxes to multiple fax machines worldwide, the IntraLinks technology stores all the documents in one secure online location where instantly all parties will receive and can review them. For Sankyo the IntraLinks "fax-in" service will facilitate the communication and transfer of clinical documents to the trial's DSMB (Data Safety Management Board), and its steering and endpoint committees.
"IntraLinks is looking forward to a successful partnership with Sankyo," said Dave Espenshade, Director of Sales - Life Sciences Europe. "Given the size and scope of the ROADMAP trial, we believe our technology offers Sankyo a perfect solution to enable secure online document exchange and to streamline processes associated with study start-up and conduct across the expanding European clinical trial market, including the EU accession states."
About Sankyo Pharma GmbH
Today, Sankyo Co., Ltd. with its head office in Tokyo is one of the leading pharmaceutical companies in Japan with worldwide activities.
Sankyo's growing importance is based on its large-scale research and development activities, which have led to an extraordinary range of innovative products meeting the highest international standards. After the compound pravastatin, the compound Olmesartan, the latest Angiotensin II Receptor Blocker (ARB), is currently being introduced in all European Markets. Olmesartan is the active compound of the ROADMAP study.
Sankyo Pharma GmbH was included in the Sankyo Group. It is the European headquarters and the European marketing and distribution centre for Sankyo Tokyo. Sankyo Pharma GmbH has subsidiaries in 11 European countries
About IntraLinks
IntraLinks (www.intralinks.com), the leading provider of digital workspaces, connects business communities and accelerates the intelligent flow of information and documents among participants. Through IntraLinks' secure, neutral, online environments, companies are better able to compete globally by accelerating essential business processes, simplifying communication and fostering rapid workflow. IntraLinks is easily accessible anywhere, anytime using a web browser.
Since April 1997, more than 150,000 participants representing over 13,000 companies worldwide have used IntraLinks digital workspaces to communicate and collaborate on more than 20,000 projects and transactions. IntraLinks has been rapidly adopted by the financial services and pharmaceutical markets. Over 250 global companies are IntraLinks clients, including AstraZeneca Pharmaceuticals LP, Bank of America, Bank One, Bear Stearns, Deutsche Bank, Dresdner Kleinwort Wasserstein, Ernst & Young, FDIC, JPMorgan Chase, TD Securities, Thomas Weisel Partners and WestLB. Founded in June 1996, IntraLinks is headquartered in New York with offices in Boston and London.