Harnessing Clinical Research Management Systems and EHRs for clinical research Clinical Research Forum IT Roundtable John S. McIlwain, CEO Velos, Inc. November 17, 2016
Topics Velos Background Clinical Research IT Strategy Operations and Tactics Opportunities
Velos Background Parent business launched in 1991 Novel idea of leveraging low cost, welleducated software developers in India Software product focus Have developed a few dozen products in a variety of industries Holding company is 121 st Street Partners The holding company has equity stakes in a half dozen companies Velos and Aithent, our off shore company, employ about 350 people
Velos Founders John S Mcllwain Chairman, President, & Co Founder Amar P. S. Chahal, MD EVP &Co Founder N. Venu Gopal Co Founder 25+ years experience in the software industry with expertise in management, sales, marketing and finance. Chairman and President from September 1996 to June 2000 and from July 2001 to present. President of Aithent, Inc. from 1991 to 1996. Prior to Velos and Aithent, held a variety of executive management, consulting, finance and sales positions for companies such as Sun Microsystems and Price Waterhouse. John also served as Adjunct Professor of Management and Operations Science at Columbia University GSB. MBA from the Columbia University and a BA in English and Economics from Middlebury College. 30+ years experience in surgery, healthcare informatics and clinical research strategies. Held several key roles since 1996, including Executive Vice President of both Operations and R&D, and CTO. Past accomplishments include, Director of Health Services for Software Services International, Inc., Consultant to Merck & Company, Resident and then practicing orthopedic/vascular surgeon in NHS, London, England. MBA from Columbia University, Fellowship exams in Surgery from Royal College of Surgeons, Edinburgh, Scotland, and an MD from Armed Forces Medical College, Pune, India. 25+ years experience in the software industry with specialization in object technology, pattern recognition and artificial intelligence. Co founded and currently serves as CEO of Aithent, Inc., and is a member of Board of Directors of CareNet International in Japan. Worked with Fuji Xerox and Stanford Research International, and also as an Adjunct Professor at Columbia University GSB. MBA from Columbia University, and a Bachelor s and Master s in Engineering from Tokyo Institute of Technology, Tokyo, Japan.
121 st Street Companies Aithent Velos Pagoda Health Data Insights Offshore software product development; financial service industry, software products Clinical research and specialty medicine Knowledge management Healthcare claims (founding investors and advisors) BayaTree Rhoads Online Comaiba Stafa CT Offshore healthcare IT services Insurance industry compliance and education Operational Excellence Cell therapy operations
Velos History Founded in 1996, focused on medical records Pivoted to clinical research in 2004 Launched Velos eresearch in 2006 A few metrics: About 70 customers Velos customers receive roughly half of NIH funding among the 100 largest such funding recipients About a third of the CTSA use one or more Velos products 10,000 studies with active status across the Velos customer base 550,000 patients 400,000 samples 35,000 users 2,000 sites Employ about 100 people 45 in the U.S., 55 off shore Focused on clinical research and cell therapy
StafaCT unit StafaCT is an integrated, configurable, and comprehensive cellular therapy software solution.
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StafaCT Solution Workflow 9
Clinical Research IT Strategy The Drivers Need for cost and time efficiency Precision Medicine opportunities, challenges Data standards and lack thereof Playing to core competencies Data utility and the learning organization Sponsor challenges and opportunities are largely the same
New product launches substantially increased R&D investment starting around 2011 2013 Comaiba 2014 Volunteer 2015 Stafa IDS ecompliance 2006 eresearch
The Protocol Lifecycle Can be complex, siloed and inefficient
CTMS versus CRMS: The ideal is a unified, integrated CRMS approach
High level view of an integrated CRMS in large site settings Institutional Review Board (IRB) System Hospital Billing System Protocols/ Patients/Subjects/ Drugs/Samples CRMS Research Billing Office Electronic Health Record (EHR) Data Warehouse(s) Laboratory Information (LIMS) Partial List IRB Click InfoEd Pro IRB imedris Proprietary EHR/ ADT Epic Cerner GE Meditech Siemens Allscript Warehouse Proprietary LIMS IDX Proprietary Warehouse Billing Peoplesoft Lawson Other HR Security
CRMS Operations and Tactics To mandate or not Centralized versus decentralized approaches and operations Out of the box versus tailored implementations Incremental and targeted approaches to implementation and SOPs Targeted and continuum approaches to data Grabbing the lower lying fruit Staffing and organizational change
Lower lying Opportunities Opportunity Centralize and mandate protocol administration, study calendars, coverage analysis, and budgeting. Relative difficulty Medium Impact High Consolidate and standardize sponsor contracting, budgeting, Medium High and IRB reviews where feasible. Leverage existing data sets. Low Medium to High Extend regional, national, international alliances. Medium High Focus on high pay off areas such as integration, calendar creation, charge capture and data harvesting. Low to Medium Medium to High Leverage vendor out of the box systems and implementation guidance, then improve incrementally. Low Medium to High
Other noteworthy opportunities Data provisioning Data standards Connecting the clinical research supply chain Research networks Sponsors Consolidating disparate systems and processes
National Cancer Center South Korea
Type Rand. Phase NCC Closed Trials # of participated organization Sample Size Enrolled 1. Cervical Cancer Y N/A 8 7000 6484 2007 2. Head & Neck Cancer Y II 5 92 92 2007 3. Lung Cancer N II 1 42 25 2007 4. Gastric Cancer Y II 3 130 130 2007 5. Breast Cancer Y III 6 1510 26 2008 6. Colorectal Cancer Y III 11 344 344 2008 7. Head & Neck Cancer Y II 11 96 9 2008 8. Gastric Cancer Y II 4 144 72 2008 9. Cervical Cancer N N/A 1 134 128 2008 10. Hospice N N/A 30 4000 3899 2008 11. Vocal Cancer Y II 19 282 166 2009 12. Lung Cancer N I/II 2 48 49 2009 13. Lung Cancer Y III 4 105 105 2009 14. Brain Tumor N II 19 32 14 2009 15. Dementia Y N/A 1 150 42 2009 16. Gastric Cancer Y III 13 622 623 2009 17. Cardiovascular disease Y III 10 2062 150 2009 Year
NCC Closed Trials Type Rand. Phase # of participated organization Sample Size Enrolled 18. Lung Cancer Y II 14 98 98 2009 19. Breast Cancer N I/II 1 58 15 2009 20. Breast Cancer N I 1 18 13 2009 21. Colorectal Cancer N II 1 62 16 2009 22. Liver Cancer N II 1 50 50 2009 23. Gastric Cancer Y N/A 1 148 129 2009 24. Pediatric ALL (VHR) N N/A 6 39 36 2009 25. Pediatric ALL (Relapse) N N/A 6 36 39 2009 26. Breast and Prostate Cancer Y III 6 126 67 2009 27. Lung Cancer Y III 4 242 4 2009 28. Breast Cancer N I/II 1 46 46 2009 29. Liver Cancer N II 20 93 36 2009 30. Rectal Cancer Y III 8 1160 5 2009 31. Colorectal Cancer N N/A 4 1000 883 2009 32. Hospice N N/A 34 5000 6096 2009 33. Gastric Cancer Y II 16 194 195 2010 34. Pediatric & Adolescent N N/A 11 145 152 2010 Year
Type Rand. Phase NCC Closed Trials # of participated organization Sample Size Enrolled 35. ovarian, fallopian tube, and primary peritoneal cancer Y II 9 314 9 2010 36. Breast Cancer Y II 12 69 61 2010 37. Liver Cancer N II 1 40 3 2010 38. Cancer Pain Management N N/A 1 25 25 2010 39. Lung Cancer Y II 17 120 10 2010 40. Hospice N N/A 35 7000 7083 2010 41. Gastric Cancer N N/A 12 640 621 2010 42. Lung Cancer Y II 1 84 4 2011 43. Gastric Cancer N N/A 4 700 101 2011 44. Breast Cancer Y III 15 1233 8 2011 45. Hospice N N/A 34 5000 7495 2011 46. Rectal Cancer Y II 1 82 2 2012 47. Colon Cancer Y II 1 194 197 2012 48. Hospice N N/A 34 8000 8109 2012 49. Pediatric N N/A N/A N/A N/A 2013 Year
In Summary Exciting times in Clinical Research IT EHR systems and related data have created considerable opportunity Sponsors are more aligned than ever The information technology is largely there Recognition of the need for investment, systems and systemic approaches is there Awareness of the need for data standards is nearly universal The importance of collaboration seems nearly universal Considerable opportunity lies ahead much done, much to do
Thank You! jmcilwain@velos.com