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How to Use Study Brokers to Find
       Sites and Studies

Presented at MAGI’s 2009 Clinical Research
            Conferen...
Unusual Circumstance: Economic
Recession Affects Clinical Research
 Usually a recession proof industry


 Significant di...
Challenges for Sponsor & CRO
             Personnel
 Increased pressure to do more with less personnel


 Increased pres...
Challenges for Investigator & Site
            Personnel
 Study delays/cancellations > unused site capacity >
 increased ...
What is needed?
 Sponsors & CROs need faster access to experienced
 investigator with unused capacity

 Investigators & ...
What is a study broker?
 Typically a study broker acts as a middle man
  connecting Sponsors & CROs with Investigator sit...
What does study broker do?
 Monitors drug development for clinical trial
  opportunities
 Solicit assignments from exten...
What are study broker objectives?
 Good match for sponsor/CRO and site

 Successful investigator performance

 Repeat b...
Broker is Different from SMO/TMO
 Broker usually not involved with regulatory
 documentation
   Sponsor or CRO handles t...
Experienced Study Broker Can Be
         Reality Check
 Experienced study broker is valuable resource
    Sponsors & CRO...
How Sponsors & CROs Use
  Brokers to Find Investigators
 Contact Study Broker
 Define investigator & patient population ...
How Sponsors & CROs Use Brokers
  to Find Investigators (Cont.)
 Identify protocol or site problem areas
 Identify speci...
How Sponsors & CROs Use Brokers
  to Find Investigators (Cont.)
 Broker contacts appropriate investigators
 Presents bri...
Sponsor Benefits of Using Study
           Broker
   Sponsors & CROs get rapid access to experienced
   investigators wit...
How Investigators Use Brokers
        to Find Studies
 Register site profile with each study broker
 Update profile if a...
Why Sites Use Brokers
 Improved Study Opportunity Flow & Cash Flow
    More study options > site make better choices
   ...
Why Sites Use Brokers (Cont.)
 Site business development capacity busy
    Feasibilities
    Negotiating contracts & Bu...
Sales Opportunity Funnel




Site Prospecting          Broker Prospecting

Broker will find studies site would not have fo...
Broker Fees
 Site Pay
 Sponsor Pay
Broker Fees (Cont.)
 Site Pay – usual scenario
    Typically 10-20% of Contract Value
        % varies between brokers
...
Broker Fees (Cont.)
 Sponsor Pay
    Rare disease ~ unpredictable patient numbers
       West Nile Virus
       Heredi...
Key Point for Site
 Paying broker for first study from new sponsor/CRO
  > opportunity to perform
 Good performance > ad...
8 Broker Fee Questions
 Ask each broker the following: (ILS answers used)
1. What if site signs up & decides not to do stu...
Broker Fee Questions (Cont.)
5. What is cash flow process?
   Sponsor > site
6. What if site fails to perform?
   Broker...
Site Benefits of Using Study
              Broker
 Investigators & sites get access to new study
  opportunities to maint...
Site Benefits of Using Study
          Broker (Cont.)
 Broker puts your site in circulation
 Repeat business with no fee...
Problem Solving with Sponsors
          & CROs
 Unrealistic time lines
    Broker experience can convey anticipated inve...
Problem Solving with
           Investigators & Sites
 Screening for specific site capabilities: experience,
  equipment,...
Clinical Study Brokers
   Investigator Location Services
    www.invlocate.com
    20,000+ investigator profiles/12,000+ ...
Conclusion
 Sponsors & CROs can use brokers to expedite
 investigator recruitment
   Free service
   Call your broker t...
Conclusion (Cont.)
 Investigators & sites can use brokers to fill unused
 capacity
   Accept projects when you need busi...
Contact Information
Joe A. Bollert, PhD
President
Investigator Locations Services, Inc.
1280 Bison St.
Suite B9-543
Newpor...
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How to Use Study Brokers to Find Sites and Studies

Using study brokers to increase clinical investigator recruiting and increase investigator site productivity.

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How to Use Study Brokers to Find Sites and Studies

  1. 1. How to Use Study Brokers to Find Sites and Studies Presented at MAGI’s 2009 Clinical Research Conference WEST Oct 4-7, 2009 Joe A. Bollert, PhD President
  2. 2. Unusual Circumstance: Economic Recession Affects Clinical Research  Usually a recession proof industry  Significant disruption in clinical research caused by mergers, closures, layoffs and pipeline culling  Dramatically impacted all parties
  3. 3. Challenges for Sponsor & CRO Personnel  Increased pressure to do more with less personnel  Increased pressure to expedite trials  Increased pressure to find productive sites
  4. 4. Challenges for Investigator & Site Personnel  Study delays/cancellations > unused site capacity > increased site overhead and decreased cash flow  Big problem for sites  Personnel & domain name changes @ sponsors & CROs > loss of contacts for new business- relationships disrupted  Big problem for sites
  5. 5. What is needed?  Sponsors & CROs need faster access to experienced investigator with unused capacity  Investigators & sites need access to new study opportunities to maintain staff and cash flow Study brokers can fill both niches
  6. 6. What is a study broker?  Typically a study broker acts as a middle man connecting Sponsors & CROs with Investigator sites  Simple Business Model  Services are free to sponsors & CROs  Investigators pay broker a fee if a study is placed
  7. 7. What does study broker do?  Monitors drug development for clinical trial opportunities  Solicit assignments from extensive contacts with sponsor & CRO personnel  Offer study opportunities to their database of experienced, nonexclusive investigators  Invest significantly in development & maintenance of site, sponsor and CRO contacts
  8. 8. What are study broker objectives?  Good match for sponsor/CRO and site  Successful investigator performance  Repeat business from both sides  ILS: 8 years, 285+ sponsors & CROs, 600+ projects ~80% repeat business
  9. 9. Broker is Different from SMO/TMO  Broker usually not involved with regulatory documentation  Sponsor or CRO handles this directly  Broker usually not involved with contract negotiation  Site negotiates direct with Sponsor or CRO  Broker usually not a conduit for grant cash flow  Sponsor or CRO pay site directly
  10. 10. Experienced Study Broker Can Be Reality Check  Experienced study broker is valuable resource  Sponsors & CROs  Investigators & sites  Handled many projects for many sponsors & CROs  Multiple therapeutic areas  Multiple practice settings  Insight into investigator needs & opinions  Insight into sponsor & CRO needs & opinions  Broker can be value added partner to all parties
  11. 11. How Sponsors & CROs Use Brokers to Find Investigators  Contact Study Broker  Define investigator & patient population needed  Provide protocol synopsis  Specifications  # of investigators needed  # of patients needed per investigator  # of months for patient recruiting  approximate grant per patient
  12. 12. How Sponsors & CROs Use Brokers to Find Investigators (Cont.)  Identify protocol or site problem areas  Identify special equipment or procedures  Identify any unique issues  IRB requirements: local or central  Prestudy meeting requirements
  13. 13. How Sponsors & CROs Use Brokers to Find Investigators (Cont.)  Broker contacts appropriate investigators  Presents brief description of study specifications  Confidentiality maintained in contacting investigators  Sponsor & drug not identified  Screens CVs and Site Questionnaires of interested investigators  Submits to sponsor  Sponsor takes over and follows up directly with investigator
  14. 14. Sponsor Benefits of Using Study Broker  Sponsors & CROs get rapid access to experienced investigators with unused capacity at no cost  Save time, resources and money  Uninterested investigators screened out  Deal only with interested investigators  Leverage broker contacts with sites
  15. 15. How Investigators Use Brokers to Find Studies  Register site profile with each study broker  Update profile if additional medical specialties join the site  Review study opportunities when presented  Carefully evaluate study & patient population required  Ask broker questions on issues needing clarification  Confirm if interested- time is usually critical  Follow broker specific procedures to get in front of sponsor or CRO
  16. 16. Why Sites Use Brokers  Improved Study Opportunity Flow & Cash Flow  More study options > site make better choices  Accept studies best suited to site  Better performance  Increased revenue  Decline studies not suited  Perform poorly if taken  Loose money if poorly performed
  17. 17. Why Sites Use Brokers (Cont.)  Site business development capacity busy  Feasibilities  Negotiating contracts & Budgets  Sites often have little time for prospecting  Disruption in industry contacts > prospecting even more important
  18. 18. Sales Opportunity Funnel Site Prospecting Broker Prospecting Broker will find studies site would not have found.
  19. 19. Broker Fees  Site Pay  Sponsor Pay
  20. 20. Broker Fees (Cont.)  Site Pay – usual scenario  Typically 10-20% of Contract Value  % varies between brokers  Terms may vary between brokers  No cost to site if opportunities are not found
  21. 21. Broker Fees (Cont.)  Sponsor Pay  Rare disease ~ unpredictable patient numbers  West Nile Virus  Hereditary Immune Deficiency  NIH Stroke Prevention Study  Unusual requirement/challenges  Patients coming from sponsor arranged referral site
  22. 22. Key Point for Site  Paying broker for first study from new sponsor/CRO > opportunity to perform  Good performance > additional new study opportunities with no broker fee  Amortize initial broker fee over future business  Look at every brokered study as opportunity to develop a long term client
  23. 23. 8 Broker Fee Questions Ask each broker the following: (ILS answers used) 1. What if site signs up & decides not to do study?  Broker fee owed only if site commits to sponsor 2. What if 2 brokers submit a site?  Sponsor can specify who gets credit 3. Who negotiates final budget?  Site 4. What if site negotiates a higher grant?  Broker fee does not change
  24. 24. Broker Fee Questions (Cont.) 5. What is cash flow process?  Sponsor > site 6. What if site fails to perform?  Broker fee still owed 7. What if sponsor brings additional studies directly to site?  No fee owed to broker 8. Does broker charge site and sponsor on same project?  No
  25. 25. Site Benefits of Using Study Broker  Investigators & sites get access to new study opportunities to maintain staff and cash flow  No cost to be in broker database  No cost to review study opportunities  Cost effective - pay only if study is placed
  26. 26. Site Benefits of Using Study Broker (Cont.)  Broker puts your site in circulation  Repeat business with no fee owed to broker  New business from other project teams  Leverage broker contacts with sponsors & CROs
  27. 27. Problem Solving with Sponsors & CROs  Unrealistic time lines  Broker experience can convey anticipated investigator response  Unrealistic budget  Broker experience can convey anticipated investigator response  Sponsor or CRO slow to respond after site submission  Broker action can prevent investigator loss of interest
  28. 28. Problem Solving with Investigators & Sites  Screening for specific site capabilities: experience, equipment, special procedures & services  Broker screens before submission to sponsor 0r CRO  Site slow to respond jeopardizing study opportunity  Broker action stimulates response  Site files incomplete Site Questionnaire  Broker action secures missing information before submission  Broker Fee based on potential value ensures site will give priority & maximize performance
  29. 29. Clinical Study Brokers  Investigator Location Services www.invlocate.com 20,000+ investigator profiles/12,000+ industry contacts  Principal Link www.principallink.com 2,500+ investigator sites/1,600+ industry contacts  Investigator Support Services www.researchsite.net 1,200+ investigator sites/9,000+ industry contacts
  30. 30. Conclusion  Sponsors & CROs can use brokers to expedite investigator recruitment  Free service  Call your broker today
  31. 31. Conclusion (Cont.)  Investigators & sites can use brokers to fill unused capacity  Accept projects when you need business:  90% of something is better than 100% of nothing  Decline projects when you are at capacity  Evaluate & register with appropriate brokers
  32. 32. Contact Information Joe A. Bollert, PhD President Investigator Locations Services, Inc. 1280 Bison St. Suite B9-543 Newport Beach CA 92660 949-417-0437 x179 jbollert@invlocate.com

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