) SYNTEX CORPORATION 81 YTH SOFTWARE SUCCESS STORY Executive Summary Customer S)'nlex Corporation Indu5tlY . Phormoceultcol5 Business Problem: Shorten drug approval process and reduce lime to markel. Solution . Using OMNIS 7. developers have built on easily portable, multi- platform user interface to on application that streamlines document management and expedites the critical drug-opprovol process 01 Syntex Corporalloll CSC Consulting, a Waltham, Ma ssClc hu setts-ba sed unit of Computer Sciences Corpo ration , has so lved its share of large-scale sys tems integration problems. This experience came in handy when the company was hired to develop a reengine er in g solution for Syntcx Corporation, a $2 billion dollar pharmaceutical company based in Palo Alto, California. The recngi- neering effort- initiated by CSC Index, another unit of Computer Sciences Corporation-was needed to support a redesign of the wa y Syntex plans, man ages, and produces new drug applications (NDA). The goal was to reduce time to market in an environ- ment where each day can mean a difference of more than a million dollars in revenue. A Staggering Amount of Coordination Over the 7 -10 years typically required to test and docum ent a new drug, documentation can run to hundreds of thousands of pages, every word of which must meet excruciating standards of authenticity, consi stency, and completeness. Collabora ti on, coordina- tion, and communication are criticaL The effort and cost can be staggering- and may determine whether a given drug makes or los es money. In the summer of 1992, managers at Syntex felt this pressure m ore than ever. They called on CSC to devise a solutio n. Choosing the Tools As project manager Steve Scribner points ou t, the solution depended on a sophisticated development tool to me et demanding objectives of sca le and functionality in the limit ed time availab le. Also critical was multi- platform supp ort, since the use r base was distributed about 50-50 between the Windows PC and Macintosh desk top systems. For these reasons Scribner and ot her members of the development team selected Blyth milNIS 7 to help them IlIJ BL YTHSOFTWARE
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SYNTEX CORPORATION 81YTH SOFTWARE SUCCESS STORY
Executive Summary Customer S)'nlex Corporation
Indu5tlY. Phormoceultcol5
Business Problem: Shorten drug approval process and reduce lime to markel.
Solution . Using OMNIS 7. developers have built on easily portable, multiplatform user interface to on application that streamlines document management and expedites the critical drug-opprovol process 01 Syntex Corporalloll
CSC Consulting, a Waltham, MassClc husetts-based unit of Computer Sciences Corporation , has solved its share of large-scale systems integration problems. This experience came in handy when the company was hired to develop a reengineering solution for Syntcx Corporation, a $2 billion dollar pharmaceutical company based in Palo Alto, California. The recngineering effort- initiated by CSC Index, another unit of Computer Sciences Corporation-was needed to support a redesign of the way Syntex plans, manages, and produces new drug applications (NDA). The goal was to reduce time to market in an environment where each day can mean a difference of more than a million dollars in revenue.
A Staggering Amount of Coordination
Over the 7 -10 years typically required to test and document a new drug, documentation can run to hundreds of
thousands of pages, every word of which must meet excruciating standards of authenticity, consistency, and completeness. Collaboration, coordination, and communication are criticaL
The effort and cost can be staggeringand may determine whether a given drug makes or loses money. In the summer of 1992, managers at Syntex felt this pressure more than ever. They called on CSC to devise a solution.
Choosing the Tools
As project manager Steve Scribner points out, the solution depended on a sophisticated development tool to meet demanding objectives of sca le and functionality in the limited time available. Also critical was multiplatform support, since the user base was distributed about 50-50 between the Windows PC and Macintosh desk top systems.
For these reasons Scribner and other members of the development team selected Blyth milNIS 7 to help them
~IlIJBLYTHSOFTWARE
I
SYNrrX CORPoRArloN
develop the application's user interface. This interface would be the front end to a client/server system based on the Documentum product and accessing a central repos itory res iJing on Sun 1000 and 2000 servers. For the user interface development platform, the team selected PC Windows.
Dramatic Savings in Time Nine month~ after launch ing development, team members released the first production version of the application, known as Worldwide Registration Management,(WRM). T oJoy WRM is lIsed by more than 400 researchers, statistici;ms, regulatory staff members, documentation specialists, and other professionals at the dlree Syntcx sites. Communications are hased on a TCP/IP LAN at each site connected hy a WAN with Sun NFS as the file-system protocol.
With WRM the savings in time have been dramatic. For example, using the old, paper-hased process, 4-6 months were typ ically required to collate, publish, and print the documents constituting a major submission. With WRM, the task takes ie" than two weeks. To generate a new-drug submission to secondary markets SrntTx might spend 3-4 months on each one . Today, Syntex can prepare the primary and all second ary submissions simultaneously.
As for documen t retrieval, users for the first time ever have on line access to almost any of the thousands of documents they need. "This kind of access ibility means everyone involved can do their job more confidently, more effic ien tl y, and more cost effectively," Scribner says.
Thanks to the multi-pla tform capabilities ofOMNIS 7, development also proceeded efficiently and cost effectively. "Essentially, we developed the user interfaces for both platforms in the time it would ordinarily take to deve lop a uscr interface for one platform," Scribner reports. Equally important are the maintenance benefits of ~wallel platform de velopment and the advantages of the OMNIS 7 Change Management System. "Upgrades are transparent across the two platforms and can be automatically downloaded to both as soon as they're ready for one," he explains.
Future Licensing Opportunities Upgrades for Syntex aren't the only enhancements that can be made to WRM. Through an exclusive license to
esc, Syntex has chosen to make the solution available to others companies with simil ar document management needs. In fact, during WRM's first yea r of deployment at Syntex, close to a dozen other pharmaceuticals showed interest in the application. "We consider WRM an exce llent foundation for other cu~tom so lutions," Scri bner says.
For more information contact:
CSC Consulting Pharmaceutical Industry Pract ice 1007 Bayhill Drive Suite 155 San Bruno, CA 94406 Phone 415.737.0700 Fax 415.737.7629
"We developed the user interfaces
for Windows and Macin/ash in
the lime if would ordinarily taKe 10
develop a user interface for one
plo~orm alone. "
Sieve Scribner,
Pro;eclleoder,
CSC Consulting
Corporate Headquarters: Blyth Soll\vore 989 Eosl Hllbdale Blvd , Suile #400 Fosler City, Colilomlo 94404 USA Ma,n Number .415.57 10222
in Fox .. .415 571. 11 32
International Sales:
Europe & Africa B~th Sollwale Umlled Unitec House 2 Alberl Place. Finchley london N3 lOB Enghnd Phone . . .. 081 .346.999 Fox .. ..081.346.171 6
Asia Pacific & Latin America Blylh Sollware 989 Eml Hillsdale Blvd , Suite #400 Fosler City, (oHromio 94404 USA PhOl1f' . ........ 415286 3580 Fox ... . .. ... .. .415.312.71 24
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