1. Expert Guidance and Support for your Request for Proposal (RFP) Process
From early clinical trial planning for your clients through to CRO contracting, we provide hands-on protocol review and clinical design optimization, guidance on your team’s RFP strategy and conduct, budget strategy, client messaging strategy, bid defense strategy and preparation, and team coaching via our clinical consulting services. For CROs (and also biotechnology companies) we guide the process of qualification and selection of the best clinical research organization, vendors, and solutions for an oncology clinical trial. We begin our engagement with your teams (in-person and/or remote) in an A-Z review of your company’s current status and commercial goals, and develop your optimized plan to ensure commercial and clinical success.
2. Study and Site Feasibility Clinical Consulting, Gap Analysis
In close engagement and collaboration (in-person and/or remote) we provide strategic insights and solutions to enhance early protocol and trial planning, study design, strategic feasibility, and clinical trial launch. Our strategic clinical consulting will ensure study planning is considering the correct country-site-patient strategy, follows applicable FDA guidance, has identified and mitigated key risks, and has expert insight into expected timelines and outcomes. We provide a review of key trial parameters to modify planned studies, where recommended.
3. Oncology Trial Optimization
Working in close collaboration (in-person and/or remote) with your team and any other consultants and external collaborators, we address the current competitive landscape that may compete for site resources and patient populations with a clinical study. Other strategic clinical consulting services that will enhance trial performance prior to study launch are protocol review, developing patient recruitment and retention plans, endpoint and data needs analysis, and study lifecycle forecasting.