Dr. Vogel has helped many sponsors solve outsourcing problems and optimize their use of vendors through services in the following areas: Deciding Among Outsourcing Options, Selecting and Contracting With Vendors, Managing the Sponsor-Vendor Relationship, Training Personnel on Working With Vendors, and Accelerating the Vendor Contracting Process.

"Dr. Vogel's interviews of key stakeholders at Procter & Gamble Pharmaceuticals and critical recommendations led to the successful design of our Worldwide Clinical Operations organization."

Benjamin Floyd, Ph.D., Former Vice President
Worldwide Clinical Operations, Procter & Gamble Pharmaceuticals

"We have achieved some of our best results when we have worked with Sponsors that employ the tools that Dr. Vogel has developed to manage Sponsor-Provider relationships. These common sense, pragmatic tools not only improve communication and teamwork, but ensure that the unanticipated obstacles that emerge in most clinical trials are successfully managed by the team."

Steven M. Rauscher, Chief Executive Officer
Affiliated Research Centers, Inc.

Deciding Among Outsourcing Options:

• Developing an outsourcing strategy -- Developing a "strategic" outsourcing plan helps sponsors to avoid the pitfalls of "tactical" outsourcing (last-minute decisions) and "maximum" outsourcing (disregard for specific project needs).
• Deciding when to "insource" -- There are cases in which it is advantageous to use CROs as a source of personnel who work under the sponsor’s direction.
• Using investigator networks and site management organizations -- In addition to CROs there are "new" pharmaceutical services that may accelerate clinical development.

• Prequalifying CROs -- Evaluating CROs and presenting detailed documentation on highly qualified candidates enables sponsors to accelerate study initiation.
• Preparing requests for proposals (RFPs) -- Defining activities and materials for planned studies (study specifications) and providing precise instructions for CRO bidders improves the level of detail in CRO proposals, reduces the dollar variance in bids received, and reduces cost overruns.
• Evaluating CRO bids -- Conducting independent, detailed evaluations of CRO bids helps to detect and resolve potential misunderstandings and ensure maximum value for the sponsor.
• Conducting financial and contract negotiations -- Applying experience gained from a range of previous assignments provides a valuable perspective, which helps sponsors prepare for negotiating with CROs.

• Defining quality standards and using "performance metrics" helps sponsors to ensure that their expectations are achieved.
• Designing and conducting "kick-off" meetings ensures that the sponsor and CRO have realistic expectations, understand their respective roles and responsibilities, and practice efficient communication and problem-solving.
• Planning oversight meetings between sponsors and CROs helps sponsors to manage study timelines and budgets.
• Identifying and resolving issues -- Recognizing "red flags" helps sponsors to keep studies on time and on budget.
• Arbitrating sponsor-CRO disputes -- Providing neutral "third party" assistance to sponsors and CROs who are unable to resolve differences may help them to avoid "legal" action.

• Conducting in-house training on working with CROs -- The workshop, A Practical Approach to Achieving Success With CROs and Other Outsourcing Providers, enables participants to gain hands-on experience and develop the skills for working efficiently with CROs.
• Developing written guidelines on working with CROs -- Guidelines that are based on proven concepts and written with the sponsor’s team provide direction on how to accomplish specific tasks in 16 different areas.

• CRO Directories -- Providing custom directories of CROs having the necessary experience, qualifications and resources to conduct studies in specific therapeutic areas enables sponsors to quickly identify CROs for future studies.
• Centralizing contract administration -- Contract administration departments that are designed to serve as a central resource for selecting and contracting with CROs can achieve significant savings in CRO costs.
• Preferred provider agreements -- Evaluating potential preferred providers and making recommendations for managing sponsor-CRO alliances helps sponsors to ensure value.

Pharmaceutical clients have included:

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John R. Vogel Associates, Inc.
328 Pualoa Nani Place / Kihei, HI 96753
Phone: (808) 875-6063 / Fax: (808) 875-0913
Email: mail@jrvogel.com