Today, there are many obstacles in planning clinical trials. Complex study requirements, global patient populations, limited personnel, constrained financial resources and the need for shorter timelines all contribute to making study planning a prolonged and difficult exercise for life sciences sponsors. Further, outsourcing all or part of these studies to a contract research organization (CRO) can add another layer of complexity.
The request for proposal (RFP) and bid evaluation process for outsourcing to CROs is time-consuming and cumbersome. Since each CRO organizes tasks and resources differently, evaluating trial bids can be like comparing giraffes to elephants, leading to study start delays and numerous change orders due to omitted, misunderstood or under-bid tasks.
Clinical organizations need a way to plan and source trials easily, while developing realistic trial budget estimates. They also need a tool to create and modify RFPs based on the trial project plan, understand fair market value for outsourced tasks, easily compare vendor bids, and leverage benchmark pricing for better negotiations and reduced cycle times.
These organizations need an advanced budgeting, scenario planning, and sourcing solution that can deliver on all of these needs. One that not only enables them to gain trial planning process efficiencies, determine the optimal outsourcing model for a given trial, and leverage industry intelligence for better negotiations, but also one that significantly shortens RFP and bid management cycles while saving money.
They require a unique solution that can take a bottoms-up approach to create a budget estimate starting with known assumptions for a given trial such as locations, sites, patients, enrollment, and so on. Most importantly, when any of the inputs or drivers change, they need immediate visibility into the impact of these changes on the trial’s costs, resources, and timelines. Such a solution should significantly reduce the forecasting process and produce accurate budget/resource estimates in minutes. It must also be able to generate RFPs directly from project plans at varying levels of detail. It should enable users to evaluate and compare multiple planning scenarios and vendor bids against each other and/or industry benchmarks to quickly determine the optimal sourcing strategy, as well as identify discrepancies and variances with vendor bids. Altogether, these features can significantly reduce trial planning and RFP management, as well as vendor evaluation and negotiation cycle times.
Are you interested in learning more about this type of solution that can generate fast, easy RFPs and reduce your trial planning and outsourcing time?
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Julie Smiley is Sr. Director of Life Sciences Product Strategy at Oracle. She has nearly 20 years of experience in the pharmaceutical industry and holds an MS in Computer Information Systems from Boston University with a focus in database and knowledge management. For most of her career, Julie led data management and database programming organizations and as a solution strategist for Oracle Health Sciences, she continues to lead in driving efficiencies across clinical R&D.