Designing and Implementing Best Practices for Pharmaceutical, Biotechnology & CROs

    Case Studies


CASE STUDY #1: Preferred Provider Selection
~ Assignment: Company needed assistance with the selection of preferred providers
~RHB developed a Request for Information, compiled a list of potential providers, assisted in developing their criteria for selection, analyzed RFI responses, recommended a short list that met the criteria, developed mock RFP, analyzed results, negotiated preferential pricing
~ Outcome: A short list of preferred global, niche, and functional providers

CASE STUDY #2: Phase IV Provider Selection
~ Assignment: Company was preparing to launch their first Phase IV trial
~ RHB worked with the Company to identify potential providers, assisted in defining the project scope, prepared the RFP, analyzed the proposals, facilitated the proposal defenses, recommended the provider; negotiated the budget, MSA and Work Order
~ Outcome: RHB saved the Company 25% from original bid, shortened the timeline for selection and continues to monitor this project

CASE STUDY #3: Administration of an Independent Medical Grant Program
~ Assignment: Company needed assistance in managing their Post-Marketing Independent Medical Grant Program
~ RHB assisted the Company with the administrative management of their program including: receiving, tracking and processing of grant applications, working with the Committee to finalize awards, resolving issues with Investigators, negotiation of letter agreements, and processing of payments
~Outcome: Program is functioning so well the contract was renewed for 5 years

CASE STUDY #4: Master Services Agreements
~ Assignment: Company needed eight international MSAs executed in 2.5 months
~ RHB contacted all the selected providers, prepared and sent out the MSAs, negotiated contract terms, finalized pricing, processed for execution
~ Outcome: All agreements were finalized before the deadline

CASE STUDY #5: Expert Help
~ Assignment: Senior Contract Manager took a 6-month maternity leave, Company needed an experienced temporary replacement
~RHB stepped in and independently managed all existing contracts, outsourced new projects, negotiated contracts and budgets, worked with project teams
~Outcome: Work load was managed, no projects were delayed, all systems were maintained

CASE STUDY #6: Strategic Business Plan
~ Assignment: Company needed assistance to launch a new business unit
~ RHB worked with the principals to develop a strategic business plan, develop marketing concepts and collateral, define revenue targets, launch the business unit and measure success
~ Outcome: Business plan adopted and unit is meeting goals

CASE STUDY #7: Medical Writing
~ Assignment: Company needed help in preparing and finalizing a protocol in one month
~ RHB researched the project, developed the outline, worked with the medical/scientific staff to complete the protocol according to their SOPs
~ Outcome: Protocol was accepted and completed within the timeframe

CASE STUDY #8: Re-engineering the Outsourcing Process
~ Assignment: Company had outgrown their current outsourcing strategy, department needed to be re-engineered to meet future needs
~ RHB worked with the Director to review the process, strategy, tools, and templates to institute best practice across all outsourced activities
~ Outcome: Recommendations were accepted, RHB is assisting in the implementation

CASE STUDY #9: Investigator Contract Negotiations
~ Assignment: Company had difficulty maintaining consistent process across multiple CRO partners for the negotiation of Investigator Grants and Contracts. Internal resources were limited
~ RHB worked with Investigator Contracts Group to develop a Team of external consultants well versed in their processes and available to meet critical time points
~ Outcome: RHB became the preferred provider for budget and legal negotiations with Investigators on all outsourced projects. Contract negotiations generally completed within 10 weeks of site contact

CASE STUDY #10: Due Diligence Audits
~ Assignment: Potential Buyer needed assistance evaluating the compatibility and potential growth of a company they were considering acquiring
~ RHB performed a business due diligence audit including a full quality assurance audit and prepared a full analysis of the company's current and future business potential
~ Outcome: Company was successfully acquired

CASE STUDY #11: Training
~ Assignment: Company had limited experience in outsourcing projects and needed an orientation to outsourcing models and current "Best Practice"
~ RHB worked with the management team to prepare a two day course on outsourcing practice and contract management
~ Outcome: Course was well received by the Operations team and RHB provided additional assistance to set up a customized outsourcing model

CASE STUDY #12: Project Management of Investigator Contracting Process
~ Assignment: Company has experienced delayed start-up, inconsistent contract terms, and negotiation issues with CROs managing the contracting process particularly with global trials.
~ RHB worked with Outsourcing and Legal to develop a consistent and well-monitored process for the management of the CRO negotiations including final audit of the agreement prior to final execution.
~ Outcome: Sponsor, CRO and Investigators are pleased with the process. Time to contract is consistently beating industry average based on site type. Quality of the final contract has significantly increased with greater Sponsor protection and consistent budget negotiations.

RH Bouchard & Associates can assist you in meeting your goals for the future. Whether you need strategic support or just hands-on help, we have the skills and experience to meet your needs. Contact us at: 401-624-7288 or at
RH Bouchard & Associates, Inc.
25 Reliance Drive
Bristol, RI 02809
Phone: 401-624-7288
Fax: 401-624-7289
Mobile: 508-292-7904

Copyright 2007