How to Automate Clinical, Safety, and Business Processes with Innovative Technology
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Perficient is a leading digital transformation consulting firm specializing in clinical, safety, and business process automation through innovative technology. The document highlights Perficient's services, focusing on business process management (BPM) and its collaboration with Appian to improve life sciences operations while addressing industry challenges. Key use cases include automating document compliance, enhancing transparency in site payment inquiries, and accelerating time-to-market for clinical trials.
How to Automate Clinical, Safety, and Business Processes with Innovative Technology
- 1. HOW TO AUTOMATE CLINICAL, SAFETY, AND BUSINESS PROCESSES WITH INNOVATIVE TECHNOLOGY
- 2. 2 ABOUT PERFICIENT Perficient is the leading digital transformation consulting firm serving Global 2000 and enterprise customers throughout North America. With unparalleled information technology, management consulting, and creative capabilities, Perficient and its Perficient Digital agency deliver vision, execution, and value with outstanding digital experience, business optimization, and industry solutions.
- 3. 3 PERFICIENT PROFILE Founded in 1997 Public, NASDAQ: PRFT 2015 revenue $473.6 million Major market locations: Allentown, Atlanta, Ann Arbor, Boston, Charlotte, Chattanooga, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Lafayette, Milwaukee, Minneapolis, New York City, Northern California, Oxford (UK), Southern California, St. Louis, Toronto Global delivery centers in China and India >2,800 colleagues Dedicated solution practices ~90% repeat business rate Alliance partnerships with major technology vendors Multiple vendor/industry technology and growth awards
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- 5. 5 BPM PRACTICE OVERVIEW Full Lifecycle Services Strategy Implementation Operational • Advisory Services • Business Value, Strategy/Roadmap • Process & Organizational Design • Health Checks (People/Process) • Product Selection & Architecture AgnosticTechnology-Specific • Systems Integration • Custom Development • Management Consulting • Change Management • Health Checks (Technology) • QA & Testing • Education & Training • Production Troubleshooting • SupportNET: Managed Support
- 6. 6 PERFICIENT & APPIAN HOW WE WORK TOGETHER TO HELP CLIENTS Life Sciences Solutions BPM Group: BPM & APPIAN EXPERTISE Appian: LEADING BPM PLATFORM Life Sciences Group: INDUSTRY EXPERTISE
- 7. 77 FEATURED SPEAKERS Param Singh Director, Clinical Operations Perficient Evi Cohen Global Practice Leader, Life Sciences Appian
- 8. 8 AGENDA Business Process Management (BPM) Overview Appian BPM Platform Overview Appian Use Cases in Life Sciences Q&A
- 9. 9 INDUSTRY CHALLENGES Pressure from patients and patient advocates for affordable treatments Pressure from regulatory authorities for high-quality products Pressure from shareholders for maximum profits Pressure from customers for greater transparency, without compromising intellectual property
- 10. 10 BUSINESS PROCESS MANAGMENT INPUT OUTPUT A management approach to continuously improve processes and achieve organizational objects through a set of methodologies and technologies. PEOPLE PROCESS DATA
- 11. 11 APPIAN PLATFORM “Appian supports all process styles…allowing rapid innovation and discovery.”
- 12. 12 Discovery Pre-clinical Clinical Trials Commercial Launch PHASE I PHASE II PHASE III PHASE IV 6-7 Years 0.5-2 Years Indefinite Regulatory Review Scale-up & Mfg. 3-6 Years Clinical Operations (& CROs) Regulatory Operations Pharmacovigilance Chemistry Manufacturing Controls (CMC) >IND >NDA >Approval Clinical CMC Regulatory PV Compliance Commercial IT HR APPIAN PLATFORM CAPABILITIES
- 13. 13 “Appian projects are agile, its time to solution is the fastest among all vendors, and its projects require fewer internal and external resources.” stands for simplicity
- 14. 14 USE CASES
- 15. 15 BUILD YOUR INVESTIGATOR DATABASE USER GROUP Potential Investigators OBJECTIVE Allow any interested physician to create a user profile for consideration as a PI FEATURES/BENEFITS • Physician fills out a detailed user profile • System automatically notifies sponsor/CRO • Sponsor/CRO reviews profile and approves/declines adding to investigator database
- 16. 16 AVOID MAILING/SHIPPING DELAYS TO SITES USER GROUP Site Personnel OBJECTIVE Ensure correct site addresses are used for correct purposes FEATURES/BENEFITS • User corrects address mistakes (e.g., spelling errors, suite numbers) • User designates specific addresses for specific purposes (e.g. payment, shipping)
- 17. 17 MINIMIZE CHASING SITE DOCUMENTS USER GROUP Clinical Document Associates OBJECTIVE Automate the process of collecting updated versions of expiring documents FEATURES/BENEFITS • System automatically notifies the site when a document is expiring within 30 days • System automatically sends a follow-up notification after 15 days if the documents is still outstanding
- 18. 18 IMPROVE SITE DOCUMENT COMPLIANCE USER GROUP Site Personnel OBJECTIVE Improve compliance with site document requirements FEATURES/BENEFITS • Color-coded pie chart provides visual summary of document statuses with overall compliance % • User can drill into each color/status to see document details • User can upload and send documents via the portal
- 19. 19 MINIMIZE SITE PAYMENT INQUIRIES USER GROUP Principal Investigators / Site Payment Coordinators OBJECTIVE Empower sites to answer their own questions about site/investigator payments FEATURES/BENEFITS • Users see a read-only screen that displays a searchable list of site payments • Users can drill into the line items included in a payment • Users can submit a payment inquiry via the portal
- 20. 20 MAXIMIZE TRANSPERANCY INTO KEY METRICS USER GROUP Principal Investigators / Site Coordinators OBJECTIVE Empower sites to view key study metrics, such as query turnaround and hit rates, and see how they compare to target rates FEATURES/BENEFITS • Users see a read-only screen that displays key metrics (average turnaround time, number of queries/subjects/eCRFs) for sites • Users can drill into the line items to further refine the metrics
- 21. 21 SUPPORT OFFLINE TRIP REPORT COMPLETION USER GROUP Site Monitors OBJECTIVE Allow trip reports to be completed without needing a reliable internet connection FEATURES/BENEFITS • Offline version of trip report module available • When the computer or device is connected to the internet, offline version automatically syncs with CTMS
- 22. 22 ACCELERATE TIME-TO-MARKET USER GROUP Clinical operations personnel OBJECTIVE Expedite time-to-submission and time-to-market FEATURES/BENEFITS • 32% reduction in end-to-end cycle time (from 19 days to 13 days) • 60% reduction in start-up cycle time (from 12-15 days to 5-6 days)
- 23. 23 MANAGE THROUGHPUT OF SCIENTIFIC EXPERIMENTS USER GROUP Shared services team that designs, executes, and analyzes results of experiments OBJECTIVE Streamline data gathering process for better reporting and visibility of experiments FEATURES/BENEFITS • Increase in efficiency • Increase in resource utilization • Reduction in waste
- 24. 24 IMPROVE PHARMACOVIGILANCE PROCESS USER GROUP Drug safety, pharmacovigilance, and/or medical affairs personnel OBJECTIVE Track and manage safety signals to facilitate accurate reporting and improved compliance FEATURES/BENEFITS • Automated signal management process • Improved patient safety • Mobile dashboards and reports • Reduced report generation time • Complete audit trail
- 25. 25 INCREASE EMPLOYEE COMPLIANCE USER GROUP Drug safety, pharmacovigilance, and/or medical affairs personnel OBJECTIVE Help employees create, maintain, and share reliable and timely information about compliance risks that relate to the Foreign Corrupt Practices Act (FCPA) and anti- bribery and corruption FEATURES/BENEFITS • Rapid creation, maintenance, and sharing of reliable timely risk data • Standardized business rules to avoid inadvertent compliance risks • Role-based access with complete audit log for compliance
- 26. 26 AUTOMATE CAPEX REQUESTS/APPROVALS USER GROUP Back-office contracts management, finance, and/or procurement personnel OBJECTIVE Automate and accelerate capital expenditure (CapEx) requests and approvals FEATURES/BENEFITS • Reduction in CapEx and contracts management cycle by 60% (from 5-7 days to 2 days)
- 27. 27 MANAGE GLOBAL SUBMISSION TIMELINES USER GROUP Regulatory personnel OBJECTIVE Build process for handling regulatory submissions across 150+ countries, creating visibility and awareness FEATURES/BENEFITS • Shorter time-to-market for new drugs across regions and applications • Increased compliance and submission quality
- 28. 28 APPIAN USERS
- 29. 2929 FOLLOW US ONLINE • Perficient.com/SocialMedia • Facebook.com/Perficient • Twitter.com/Perficient_LS • Blogs.perficient.com/lifesciences Next up: • How to Comply with IDMP Regulatory Requirements – July 14 • Integrating Siebel CTMS with Medidata Rave and Veeva Vault – July 21
- 30. 30 THANK YOU