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

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

Challenges for Sponsor & CRO Personnel

Increased pressure to do more with less personnel

Increased pressure to expedite trials

Increased pressure to find productive sites

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sales Opportunity Funnel

Site Prospecting Broker Prospecting

Broker will find studies site would not have found.

Broker Fees

Site Pay

Sponsor Pay

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

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

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

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

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

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

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

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

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

Clinical Study Brokers

Investigator Location Services www.invlocate.com

20,000+ investigator profiles/12,000+ industry contacts

Principal Link

www.principallink.com2,500+ investigator sites/1,600+ industry contacts

Investigator Support Services

www.researchsite.net1,200+ investigator sites/9,000+ industry contacts

Conclusion Sponsors & CROs can use brokers to expedite

investigator recruitment

Free service

Call your broker today

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

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