Project Management  Across Corporate      BoundariesUtilization of the Regional Service Provider (RSP)Model when Conductin...
Assumption:Regional Service Providers  (RSP)s are better suited than large global CROs for  supporting international      ...
This Session Will Cover:• Define Regional Service Provider (RSP) Research  Model• Benefits / Challenges of the Regional Se...
Regional Service Provider (RSP)   A Regional Service Provider is defined  as a Clinical Research Organization that        ...
The RSP Model    This model reflects the use of multipleRegional Service Providers (RSPs) in support of International Clin...
The RSP Model    provides the flexibility to workwith multiple CROs      or service  providers on thesame trial that best ...
Similar Historical ModelsCentral Laboratory, CRO, Central ECGData Management CRO, Operational CRO, Central LaboratoryDrug ...
Benefits and ChallengesRSPs Vs International CROs
Definition of Large International CRO    An International (Global) CRO is a      CRO that maintains operations      across...
Benefits of International CROs One Stop Shopping for ease of contracting and Study Management Due to their size they are v...
Challenges of International CROs Lack of Flexibility (Due to the sheer size, structure must be maintained across all offic...
Challenges of International CROs               Continued   Potential of not being considered a “high value   client”   Loc...
Benefits of the RSP ModelSelect the specific venders and services based ontheir value to the trial (Location, Expertise, S...
Benefits of the RSP Model             Continued Most RSPs have a flat management structure and provide limited services, r...
Challenges of RSP Model Potential for confusion requiring additional effort in managing multiple contracts and multiple se...
Implementing an RSP Model
Managing Multiple Vendors RSPs provide their clients flexible options for Vendor        Management and Project ManagementV...
Pre-Contract WorkConfirm size and experience of potential RSPReview financial information if availableAsk for referencesSe...
Communication Planning   Always plan for additional “Up Front” face     to face meetings with the study teamPlan at least ...
Operational PlanningPlan to perform co-monitoring visits periodicallythroughout the trial  If possible co-monitor a few si...
RSP Model ValueReduced Rates offer significant Savings (35 – 50%)Mid Sized and smaller Pharma get treated asprimary “Big P...
Assumption: Regional Service Providers   (RSP)s are better suited  than large global CROs for   supporting international  ...
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Rick Leach Euro Meeting Presentation 2007 Final

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Slides from 2007 Euro DIA Presentation

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Rick Leach Euro Meeting Presentation 2007 Final

  1. 1. Project Management Across Corporate BoundariesUtilization of the Regional Service Provider (RSP)Model when Conducting Global Programs Rick Leach Vice President Global Clinical Trials, LLC 609-731-2225
  2. 2. Assumption:Regional Service Providers (RSP)s are better suited than large global CROs for supporting international trials
  3. 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. 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. 5. The RSP Model This model reflects the use of multipleRegional Service Providers (RSPs) in support of International Clinical Trials or Programs. (Single Country, Multi-Country, Multiple Services)
  6. 6. The RSP Model provides the flexibility to workwith multiple CROs or service providers on thesame trial that best reflects the needs of your specific Study. Most RSPs have been performing clinicalservices for more than 5 years
  7. 7. Similar Historical ModelsCentral Laboratory, CRO, Central ECGData Management CRO, Operational CRO, Central LaboratoryDrug Packaging, Central Laboratory, Central ECG
  8. 8. Benefits and ChallengesRSPs Vs International CROs
  9. 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. 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. 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. 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. 13. Benefits of the RSP ModelSelect the specific venders and services based ontheir value to the trial (Location, Expertise, Service)Select Countries based on Good Feasibilities, notnecessarily where a venders offices may be locatedStrong local knowledge of Sites, Regulatory,Import/export due to many years of localexperience.In the RSP Model all providers are contracted andeach provider works hard to uphold it’s contractualresponsibility
  14. 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. 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
  16. 16. Implementing an RSP Model
  17. 17. Managing Multiple Vendors RSPs provide their clients flexible options for Vendor Management and Project ManagementVendor Management:Option 1: Lead CRO maintains all contracts and is wholly responsiblefor the contractual responsibility of the project (One contact onecontract)Option 2: Sponsor Contracts with Each Vendor (More labor intensive)Project Management:Option 1: Lead CRO provides international Project Manager tooperationally oversee the entire project from local officeOption 2: Sponsor wants to maintain PM control and places their ownPM in charge of the project. Each RSP Project Manager will reportdirectly to the PM
  18. 18. Pre-Contract WorkConfirm size and experience of potential RSPReview financial information if availableAsk for referencesSend team to visit/audit the RSP and other Vendorsprior to awarding the projectMeet with prospective team and project manager, ifat all possibleEnsure Commitment and define activities clearly
  19. 19. Communication Planning Always plan for additional “Up Front” face to face meetings with the study teamPlan at least 1 day prior to the investigator meeting to pull theentire team together and cover SOPs and expectations with theteam.Allow for weekly project team meetings and request reportsPlan for Monthly team/sponsor meetings to discuss in detailspecific issues associated with the trialAlways work off of a communication plan which outlines allparties 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. 20. Operational PlanningPlan to perform co-monitoring visits periodicallythroughout the trial If possible co-monitor a few sites during the initiation visitsPlan to audit 10 – 15 % of the sites during thetrial or following it’s completionAttend all monthly conference calls and expectfollow on report - ask questionsTry to meet with each investigator at their site atleast once early on in the trialAllow all site and investigator payments to gothrough RSPHold a Kick Off team meeting to address SOPs aswell as protocol specific items
  21. 21. RSP Model ValueReduced Rates offer significant Savings (35 – 50%)Mid Sized and smaller Pharma get treated asprimary “Big Pharma” clientsFlexibility to contract with the service providersmost experienced for all aspects of the trial.All team members are trained to the Sponsor SOPsspecific for each service the RSP is providingConfidence in knowing that your sites are beingtreated professionally as is expected within theculture of their society.
  22. 22. 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…

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