The document discusses how clinical research was impacted by the economic recession through mergers, closures, layoffs and pipeline culling. It describes how study brokers can help sponsors/CROs find investigators efficiently and help investigators find new study opportunities. Study brokers maintain databases of investigators and screen studies to match sponsors' needs, helping to fill unused investigator capacity and maintain cash flow. Brokers provide value to both sponsors and investigators by expediting investigator recruitment without cost to sponsors.

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Sales Opportunity Funnel
Site Prospecting Broker Prospecting
Broker will find studies site would not have found.

19. Broker Fees
 Site Pay
 Sponsor Pay

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Conclusion
 Sponsors & CROs can use brokers to expedite
investigator recruitment
 Free service
 Call your broker today

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. 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