Project Management Across Corporate

Boundaries

Utilization of the Regional Service Provider (RSP) Model when Conducting

Global Programs

Rick LeachVice PresidentGlobal Clinical Trials, LLC609-731-2225

Assumption:

Regional Service Providers (RSP)s are better suited

than large global CROs for supporting international

trials

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

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

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)

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

Similar Historical Models

Central Laboratory, CRO, Central ECG

Data Management CRO, Operational CRO, Central Laboratory

Drug Packaging, Central Laboratory, Central ECG

Benefits and Challenges

RSPs Vs International CROs

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…).

Benefits of International CROsOne Stop Shopping for ease of contracting and Study ManagementDue 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 servicesTheir Corporate experience is strong and employees are typically very experiencedComfort in using a well established and known CRO with additional available resourcesConsistent and Standardized SOPs

Challenges of International CROsLack 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

Potential of not being considered a “high value client”Local office leadership being provided by lead CRA or Sr. CRA, not necessarily a Project ManagerMired in the historical “Change of Scope” business practicesOne Stop Shop, when all services may not be of equal quality or needed for the specific project

Challenges of International CROs Continued

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 locatedStrong 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

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 accountabilityFlexibility in contracting and in addressing study hurdles as they arise

Benefits of the RSP Model Continued

Challenges of RSP ModelPotential for confusion requiring additional effort in managing multiple contracts and multiple service providersInternational Project Manager potentially having less international or therapeutic experienceFrequent lack of a common SOPs between RSPsFinancial viability of each individual RSP Member

Implementing an RSP Model

Managing Multiple VendorsRSPs provide their clients flexible options for Vendor

Management and Project ManagementVendor 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

Pre-Contract Work

Confirm size and experience of potential RSPReview financial information if availableAsk for referencesSend team to visit/audit the RSP and other Vendors prior to awarding the projectMeet with prospective team and project manager, if at all possibleEnsure Commitment and define activities clearly

Communication Planning

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 reportsPlan for Monthly team/sponsor meetings to discuss in detail specific issues associated with the trialAlways 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 SAEsFrequency and structure of team meetingsCommunication process for protocol related issues

Always plan for additional “Up Front” face to face meetings with the study team

Operational PlanningPlan 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 completionAttend all monthly conference calls and expect follow on report - ask questionsTry to meet with each investigator at their site at least once early on in the trialAllow all site and investigator payments to go through RSPHold a Kick Off team meeting to address SOPs as well as protocol specific items

RSP Model Value

Reduced Rates offer significant Savings (35 – 50%)Mid Sized and smaller Pharma get treated as primary “Big Pharma” clientsFlexibility 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 providingConfidence in knowing that your sites are being treated professionally as is expected within the culture of their society.

Assumption:

Regional Service Providers (RSP)s are better suited

than large global CROs for supporting international

trialsBeauty 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…