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Managing Regulatory Documents & Processes w/ SharePoint 2010 & NextDocs April 12th, 2011 Erik Smith – VP of NA Sales and Alliances Kathie Clark – Director of Product Management 1
NextDocs Corporate Overview Global Provider • Established US, EU and Asia footprint Proven Solution • SharePoint-based document and quality management. Solutions for Regulatory, Clinical, Quality, and Corporate business areas Market Leader • More than 85 FDA regulated customers; including major pharmaceutical companies, biotech firms, medical device companies, CROs, and laboratories Compliance Certification • ISO 9001 certified, as well as complete Global Headquarters US Regional Offices European Offices adherence to 21 CFR Part 11 guidelines King of Prussia, PA New York, NY Paris, France Munich, Germany Raleigh, NC London, England Microsoft Gold Certified Partner San Diego, CA Irvine, CA Asia Offices • Managed Partner, SharePoint Advisory Seattle, WA Japan Council, MOSS 2007 and SharePoint 2010 Columbus, OH Launch Partner, 2010 Life Sciences British Columbia, Canada Innovation Award Recipient, 2010 Life Sciences Partner of the Year
Recent NextDocs Recognition NextDocs named #52 on prestigious INC. 500 List – placing #1 for the Philadelphia Metropolitan area and #5 in the Software Industry category. Awarded the Microsoft 2010 Life Sciences Partner of the Year at the recent Microsoft Worldwide Partner Conference in D.C NextDocs named #1 on the Philadelphia 100 as the most successful, fastest growing, privately owned business across all verticals and all business segments in the region. Named a 2010 Microsoft Innovation Award Winner for work with Stanford University Hospital & Clinics on deployment of NextDocs SOP Module
Life Science Industry Challenges • Increased Drug Development Time and Cost: • 10 – 15 years = average time to bring a new drug to market • $1B+ = average cost to bring a new drug to market • Increase regulatory scrutiny & adherence to requirements • Does the drug provide increased or enhanced efficacy…? • Does the drug provide better safety…? • Plus, Internal Process Improvements: • 90% = amount of corporate memory existing on paper • 15% =average time spent reading factual content • 50% = average time spent searching for content • 19 = average number of times document gets copied • 25% = annual document growth rate
Life Science Industry Challenges • Need for Collaboration and Control of Compliant Content: • The lack of a centralized, globally accessible platform to manage and store essential study documentation • Inconsistent document management processes across the organization and between organizations • Inconsistent or incomplete work assignments • Inefficient notification of key events requiring follow-on action • Incomplete, missing, expired or redundant documentation • Other technical, administrative or security related obstacles Lack of an effective document management system can lead to loss of expert knowledge, inconsistent procedures and processes, re-work, flawed decision making, and missed deadlines, all of which ultimately translate to increased costs.
Kathie ClarkRegulatory Dome ManagementDemonstrationDemonstration 10
Summary INDUSTRY ISSUES DRUG DEVELOPMENT TIME & COSTS CONTINUE TO INCREASE OPERATIONAL EFFICIENCIES MUST INCREASE MANY CLIENTS ARE STILL WRESTLING WITH MANUAL OR HYBRID PROCESSES BUILT FOR SUBMISSIONS AUTOMATED PRODUCTION OF SUBMISSION READY DOCUMENTS eCTD ARCHIVING INTEGRATION W/ ALL PUBLISHING TOOLS EASE OF IMPLEMENTATION CONFIGURED NOT CUSTOMIZED ALIGNMENT W/ DIA REFERENCE MODEL ADHERENCE TO REGULATORY REQUIREMENTS