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Welcome

Welcome. Follow us and stay connected through social media :. @mySCRS and #SiteSolutionsSummit. Site Solutions Summit Networkers Group. Disclaimer. Check with your professional consultants (legal, financial, HR, etc.) to obtain specific information pertaining to your company.

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Welcome

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  1. Welcome

  2. Follow us and stay connectedthroughsocial media: @mySCRS and #SiteSolutionsSummit Site Solutions Summit Networkers Group

  3. Disclaimer • Check with your professional consultants (legal, financial, HR, etc.) to obtain specific information pertaining to your company. • This information is not meant to direct you on how to address any specific issues. • Antitrust–compliance policy adherence. http://myscrs.org/24-revision-v1/policies/antitrust-compliance-policy/

  4. Beach Rules • Picnic lunch on the beach • Sponsor & CRO representative at each table • Table 45 changed to Eli Lilly • Map in your program – pg 8 & 9 • Roundtables • 1:45 – 2:30 • 2:45 – 3:30 • 3:45 – 4:30 • Receptions & Eagle Award Gala • Meet up for breakfast 8 – 9:20am

  5. Goggle was originally named? • Find It • Sum Up • Back Rub • Dig It

  6. Successful people are always looking for opportunities to help others. Unsuccessful people are always asking, “What’s in it for me?” - Brian Tracy

  7. What We All Know • Too Long • Too Expensive • Too Unpredictable

  8. What We All Want Time Predictability Cost Quality

  9. What We All Need Quality Data Reliability Speed Enrollment

  10. Cycle Time for Multisite Clinical Trials in the United States • Retrospective study • 19 organizations submitted data • 5,396 studies were submitted • 10,673 line of data submitted • About ½ of the data unusable • despite some steep intervention CTTI – Diana Abbott, Robert Califf, Briggs Morrison, Jean Bolte, Swati Chakraborty

  11. Conclusion • We are not collecting standardized measures of cycle times … to support evidence-base health care, standard measures should be developed…

  12. Where We All Need To Go - Together • Establish Global Industry Standards • Sites and the Rest of You Too • Determine What’s Important • Compliance & Business Operations • Relationship of the metrics • Then we’ll talk about all the rest… • i.e. accreditation, etc.

  13. Site Terminology & Metrics Business Foundation • Human Resource • Facility & Equipment • Business Development & Marketing • Quality • Finances • Commitment

  14. Site Terminology & Metrics Opportunity • First learn of the study – study decision for your site • Feasibility • Pre-site Visit

  15. Site Terminology & Metrics Pre-Study • Site Selection – Study Activation • Budget & Contract • Regulatory Submission • Recruitment Plan • Training • PI Meeting • Source Document Development • Equipment/Supplies/IP Management

  16. Site Terminology & Metrics Enrollment • Site Activation-Study Enrollment Ends • Screening • Consenting • Randomization • Retention • Data Management • Control of • Supplies/inventory • IP • Regulatory Management

  17. Site Terminology & Metrics Follow-Up • Enrollment Ends – LPLV • Retention • Data management • Control of inventory • Control of IP • Regulatory management

  18. Site Terminology & Metrics Close-Out • LPLV - Study Close Our Visit • Data Management • Control/Return of Inventory/IP • Regulatory close out • Achieved

  19. 5 Standard Site Terms • Opportunity • Pre-Study • Enrolling • Follow-Up • Close-Out

  20. Summit Survey Demographics Academic Sites 8%Hospital Sites 29%Private Practices 39%Sand-alone research centers 25% ______________________________________________________________________________________ Investigators 39%Site Manager/Director/VP 26%Coordinators 19%

  21. Geographic Distribution • North America 54% • Europe 30% • South America 8% • Asia-Pacific 3% • Other 5%

  22. Summit Survey Results 354 sites • 29% SCRS members • 20% Summit attendees, but not SCRS members Statically, SCRS members have sites that have been in business for more years than non-SCRS members (χ²: 7.89; p=0.05)

  23. Data Referenced Beyond The Summit Survey • Provided un-blinded

  24. Business Foundation – Step 1 • Human Resource • Facility & Equipment • Business Development & Marketing • Quality • Finances • Commitment

  25. Interviewing Practice Alwayscheck references • 78% • 60% Site Solutions Summit Survey 2012 n = 142 & Site Solutions Summit 2013 n=146

  26. Now That They’re Hired 2012 2013 Have a formal orientationprogram 62% 51% Do not always follow theorientation program 22% 73% Site Solutions Summit Survey 2012 n = 142 & Site Solutions Summit 2013 n = 146

  27. Certification of Site Staff Site Solutions Summit Sponsor/CRO Survey 2011 n = 35, 2012 n=151 & Site Solutions Summit Site Survey 2011 n = 141 & Site Solutions Summit 2013 n = 129

  28. Sites That Have a QA, Auditing Process • 74% QA ongoing studies 37% Always 29% Often 23% Sometimes 11% Rarely 1% Never Site Solutions Summit Survey 2012 n = 115

  29. Best Describes Your QA System • 37% Staff review each others work • 24% One designated person • 14% Work closely with the CRAs • 6% Want to, but can’t fine the money • 4% Hire an outside firm Site Solutions Summit Survey 2012 n = 115

  30. Percent of Sites You Work With That You Think Are Audit Ready? • <25% 32% • 26-50% 32% • 51-75% 29% • 75%+ 7% Sponsor/CRO Site Solutions Summit Survey 2012, n=149

  31. Opportunity – Step 2 • First learn of the study – study decision for your site • Feasibility • Pre-site Visit

  32. EMR Realties • 51% Have an EMR system • 78% Use it during the feasibility process to identify potential subjects • 96% SCRS Members use it during feasibility • 44% Flag identified potential records • 27% don’t have that capabilities • 22% do not flag charts • 8% are unsure if they do • 67% SCRS members flag charts Site Solutions Summit 2013 n=181

  33. Feasibility Investment Site Solutions Summit 2013 n =181

  34. Conversion Rate 2013 80% of studies pursued were awarded 2012 70% of studies pursued were awarded Site Solutions Summit Survey 2012 n=119, 2013 n = 181

  35. Study Load Statistically, a greater number of SCRS member sites were likely to be involved in higher study loads (>11) than non-SCRS members (χ²: 11.98, p<0.05) Site Solutions Summit 2013 n = 181

  36. Pre-Study – Step 2 • Site Selection – Study Activation • Budget & Contract • Regulatory Submission • Recruitment Plan • Training • PI Meeting • Source Document Development • Equipment/Supplies/IP Management

  37. Cycle Times (days) *Unclear if the IRB contact is submission or approval, those that reported the name of the IRB mostly listed central IRBs 2013 SCRS Survey

  38. Summary: IRB, Site Activation, Visits • Statistically, SCRS members were more likely to be quicker from IRB contact to site activation than non-SCRS members (r=0.65, p<0.05) • Statistically, there was no difference in the cycle times between SCRS and non-SCRS members for other aspects of site action and patient visits. (r=0.12, p>0.05)

  39. Let’s Talk About It

  40. Multi Tasking Budget, Contract & Reg Docs Simultaneously • Yes 61% • Sometime 31% • No 8% Site Solutions Summit 2013 n =108

  41. On average how many working days does it take a site to return a budget & contract? – Sponsors & CROs Only • 0-5 days • 6-10 days • 11-15 days • 16-21 days • 21+ days

  42. Budget & Contract Cycle Time Site Solutions Summit 2013 n = 108

  43. Implication of Cross Indemnification • No extra time required 47% • More than 2 weeks 32% • More than a month 9% • Deal breaker, won’t sign 12% • SCRS Members 19% • Non member 8% Site Solutions Summit 2013 n=108

  44. Accepts First Study Budget Offer Site Solutions Summit 2013 n=106

  45. What Do You Think?Best Negotiation Tips • Provide additional justificationof costs • Provide additional justificationofstaff costs • Escalate to a more senior staff person • Have the PI involved & escalate the issue • Provide past performance metrics • Walk away (or indicate strongly you will)

  46. How Are Your Negotiation Skills? Site Solutions Summit n=141

  47. Successful Negotiation Actions • 51% Provide additional justification of costs • 17% Provide additional justification of staff costs • 13% Have the PI involved & escalate the issue • 11% Provide past performance metrics Site Solutions Summit 2013 n = 181

  48. Non-Refundable Payment,Why? • Lack of monthly paymentandthis is a way to frontloadcash requirement • To recuperate start up costs • Seldom request it because we can never get it

  49. Now The TruthNon-Refundable Payment 64% To recuperate start up costs 18% Lack of monthly payment and this is way to front load cash requirement 8% Seldom request, we can never get it SCRS Members 5% Non members 11% Site Solutions Summit n=108

  50. First Payment • 57% non-refundable/administrative fee • 24% have “refundable” advances CFS Financial n = 11,472 studies

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