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Issue link: https://lifescienceleadermag.epubxp.com/i/63894
Contract Research Organizations process. Do not preselect in, or out, any vendors, but agree up front on the competencies, capabilities, and performance clinical teams can expect, and allow the RFI process to assist in the selec- tion process. The selection process by itself will not nurture the relationship with the vendor selected. Effective and collaborative governance using measures incorporated in the RFI and RFP pro- cess is more likely to result in a successful, productive relationship with quality output. Gowen: If something does not go well when negotiating the con- tract, it will probably get worse once the contract is signed. Be methodical and have internal agreement on the necessary scope of work for each CRO and stick to it throughout the RFP process, bid defense, and final selection. When scope definition changes, com- municate it clearly and consistently to all involved. Include in the contract, limits for deviation from the plan and give a clear process on what will then happen and who will bear responsibility. Ensure that you have clear instructions regarding change orders, a well- known device for dramatically increasing the cost of your trial. Be clear that you will not pay change orders unless the work has been previously approved. WHAT ARE SOME OF THE FRUSTRATIONS YOU HAVE HAD IN GOING THROUGH THE CRO SELECTION PROCESS? Kfoury: Some larger CROs have highlighted their strong experi- ence in a therapeutic area (TA) of focus, but then assigned a team that did not have depth in the field. Ultimately, the CRO project team is critical to a successful trial. A CRO's corporate experience in a given TA doesn't necessarily translate to on-the-ground team member judgment and decision-making ability. Turnover at CROs can be high. It is key to really vet the proposed project team for experience, skills, and most importantly, fit. Tokars: The greatest frustration we often encounter during the CRO selection period centers around inflexibility. Comparing different CROs for a single project can prove difficult, especially when requesting costs for services in specific formats and break- downs. Business development groups, almost stubbornly, try to fit their cost algorithms into our preferred formats and often fail miserably, adding error into the estimates. Inflexibility in what services CROs may not want to share with the team also adds a great deal of complexity to the process, as realistically estimating the costs for the shared task proves difficult. WHAT COULD CROs DO TO MAKE THIS PROCESS EASIER ON YOU? Kfoury: CROs should work to provide more transparency up front on their proposed team's specific experience within the TA and geographies in question, as well as detail how their projections 10 LifeScienceLeader.com for cost and timing in similar engagements have mapped (or not) compared to actuality. These simple steps can quickly build com- fort with sponsors around a CRO's credibility and capabilities in specific TAs of focus. Oei: It is always helpful when the CROs provide a proposal that is as comprehensive as possible. The proposal review process is often highly interactive. The CROs should be prepared to turn around queries on the proposal sponsor in a reasonable amount of time. Vetticaden: CROs need to ensure their RFP submissions include an executive summary highlighting their strategy, key differentia- tors, costs, timelines, key challenges, and mitigation strategies. It is useful to include options for consideration by the sponsor since it provides insights into the CRO's thought process and abilities. It is also helpful to identify up-front counterparts to the spon- sor's relevant team, such as the core study team, so as to rapidly build confidence with the sponsor regarding the CRO's depth and breadth of expertise. "AS A CRO, IF YOU WANT MY BUSINESS YOU NEED TO... "...show an acceptable level of expertise (both theoretical and technical com- petency) about the model/study, have a good system for communication, and be competitively priced." Tess Pulido-Rios; Research Scientist, Dept. of Pharmacology; Theravance "...earn my trust and confidence through sustained, timely delivery of accu- rate results at reasonable cost and contact my team lead directly when you anticipate issues delivering on any of these promises, i.e. speed, cost, and accuracy." Ralph Lambalot, Ph.D.; Divisional VP, Biologics Dev. & Manufacturing Launch; Abbott Bioresearch Center "...take ownership in the project, stop nickel and diming us on every clincial study, fully understand the best methods for analysis before initiating the study and providing final project estimates, and most importantly, clearly communicate the progress of the study as milestone payments are made." Chris Fields; VP Scientific Affairs; Applied Food Sciences Inc. "...give me a realistic bid and contract (not necessarily the cheapest bid) and keep to the cost and timelines promised." Kent Allenby, MD, FACP; VP, Drug Development, Proprietary Products; Dr. Reddy's Laboratories, Inc. The CRO Leadership Awards 2012