1. Project Management
Across Corporate
Boundaries
Utilization of the Regional
Service Provider (RSP)
Model when Conducting
Global Programs
Rick Leach
Vice President
Global Clinical Trials, LLC
609-731-2225
3. This Session Will Cover:
• Define Regional Service Provider (RSP) Research
Model
• Benefits / Challenges of the Regional Service
Provider Model Vs International Global CRO Model
• How to Implement a Regional CRO Model
• Management Structures of Regional Models
4. Regional Service Provider (RSP)
A Regional Service Provider is defined
as a Clinical Research Organization that
markets it’s services to the
international research community for
services in a specific country or
geographical area
5. The RSP Model
This model reflects the use of multiple
Regional Service Providers (RSPs) in support
of International Clinical Trials or Programs.
(Single Country, Multi-Country, Multiple Services)
6. The RSP Model
provides the
flexibility to work
with multiple CROs
or service
providers on the
same trial that best
reflects the needs
of your specific
Study.
Most RSPs have been
performing clinical
services for more than
5 years
7. Similar Historical Models
Central Laboratory, CRO, Central ECG
Data Management CRO, Operational CRO,
Central Laboratory
Drug Packaging, Central Laboratory, Central
ECG
9. Definition of Large International CRO
An International (Global) CRO is a
CRO that maintains operations
across dozens of countries and
regions, offering multiple services in
support of your trial (Clinical
Operations, Central Lab, ECG, Etc…).
10. Benefits of International CROs
One Stop Shopping for ease of contracting and
Study Management
Due to their size they are virtually everywhere (or
can be)
Because of their depth of services, as the project
changes they are in the best position to offer
alternatives within their package of services
Their Corporate experience is strong and
employees are typically very experienced
Comfort in using a well established and known
CRO with additional available resources
Consistent and Standardized SOPs
11. Challenges of International CROs
Lack of Flexibility (Due to the sheer size, structure
must be maintained across all offices and
departments)
Higher Rates are necessary to cover the significant
overhead involved in maintaining a global presence
and an abundance of services (Blended Rates)
Potential lack of manpower for larger studies
requiring dozens of sites to be managed by a smaller
or new office
Company Politics – Office to Office Politics
12. Challenges of International CROs Continued
Potential of not being considered a “high value
client”
Local office leadership being provided by lead
CRA or Sr. CRA, not necessarily a Project
Manager
Mired in the historical “Change of Scope”
business practices
One Stop Shop, when all services may not be of
equal quality or needed for the specific project
13. Benefits of the RSP Model
Select the specific venders and services based on
their value to the trial (Location, Expertise, Service)
Select Countries based on Good Feasibilities, not
necessarily where a venders offices may be located
Strong local knowledge of Sites, Regulatory,
Import/export due to many years of local
experience.
In the RSP Model all providers are contracted and
each provider works hard to uphold it’s contractual
responsibility
14. Benefits of the RSP Model Continued
Most RSPs have a flat management structure and
provide limited services, reducing overhead.
(Lower Rates)
Each Regional Provider has additional Project
Management built into it’s costing providing
strong local leadership and accountability
Flexibility in contracting and in addressing study
hurdles as they arise
15. Challenges of RSP Model
Potential for confusion requiring additional effort in
managing multiple contracts and multiple service
providers
International Project Manager potentially having
less international or therapeutic experience
Frequent lack of a common SOPs between RSPs
Financial viability of each individual RSP Member
17. Managing Multiple Vendors
RSPs provide their clients flexible options for Vendor
Management and Project Management
Vendor Management:
Option 1: Lead CRO maintains all contracts and is wholly responsible
for the contractual responsibility of the project (One contact one
contract)
Option 2: Sponsor Contracts with Each Vendor (More labor intensive)
Project Management:
Option 1: Lead CRO provides international Project Manager to
operationally oversee the entire project from local office
Option 2: Sponsor wants to maintain PM control and places their own
PM in charge of the project. Each RSP Project Manager will report
directly to the PM
18. Pre-Contract Work
Confirm size and experience of potential RSP
Review financial information if available
Ask for references
Send team to visit/audit the RSP and other Vendors
prior to awarding the project
Meet with prospective team and project manager, if
at all possible
Ensure Commitment and define activities clearly
19. Communication Planning
Always plan for additional “Up Front” face
to face meetings with the study team
Plan at least 1 day prior to the investigator meeting to pull the
entire team together and cover SOPs and expectations with the
team.
Allow for weekly project team meetings and request reports
Plan for Monthly team/sponsor meetings to discuss in detail
specific issues associated with the trial
Always work off of a communication plan which outlines all
parties and whom to contact under specific circumstances
Be clear regarding how and who will handle SAEs
Frequency and structure of team meetings
Communication process for protocol related issues
20. Operational Planning
Plan to perform co-monitoring visits periodically
throughout the trial
If possible co-monitor a few sites during the initiation visits
Plan to audit 10 – 15 % of the sites during the
trial or following it’s completion
Attend all monthly conference calls and expect
follow on report - ask questions
Try to meet with each investigator at their site at
least once early on in the trial
Allow all site and investigator payments to go
through RSP
Hold a Kick Off team meeting to address SOPs as
well as protocol specific items
21. RSP Model Value
Reduced Rates offer significant Savings (35 – 50%)
Mid Sized and smaller Pharma get treated as
primary “Big Pharma” clients
Flexibility to contract with the service providers
most experienced for all aspects of the trial.
All team members are trained to the Sponsor SOPs
specific for each service the RSP is providing
Confidence in knowing that your sites are being
treated professionally as is expected within the
culture of their society.
22. Assumption:
Regional Service Providers
(RSP)s are better suited
than large global CROs for
supporting international
trials
Beauty is in the eyes of the beholder; just don’t be
afraid to ask someone else to dance!
They may treat you better and cost you less…
