Expert Guidance and Support for your Request for Proposal (RFP) Process
From clinical planning launch through to CRO contracting we provide hands-on protocol review, RFP planning and launch, support, strategies, and management vis our clinical consulting services. We guide your qualification and selection of the best clinical research organization (CRO), vendors, and solutions available for your upcoming clinical trial. We begin our engagement with your teams (in-person and/or remote) in an A-Z review of your company’s scientific and commercial goals, and develop your optimized plan to ensure clinical, patient benefit, and commercial success. The following RFP process is managed 100% alongside your company and team and remains under the level of your control and oversight that has been agreed upon.
We will:
1. Review your company’s clinical planning to date, corporate goals and milestones, team capabilities and needs and wants.
2. Provide ‘Early Engagement’ and confidentiality support during outreach to CROs and CRO meetings.
3. Develop shortlist of targeted CRO vendors and highlight the Pros and Cons of each choice.
4. Develop standardized RFP specifications, functional needs, timelines and expectations.
5. Launch RFP, manage its performance, analyze deliverables, help clarify and negotiate proposals and budgets received.
6. Manage bid defense meeting (BDM) planning, coordination, conduct, evaluations.
7. Rank CRO outcomes and guide your company’s CRO selection.
8. Perform other miscellaneous tasks, as required.
Study and Site Feasibility, Gap Analysis
In close engagement and collaboration with you (in-person and/or remote) we provide strategic insights and solutions to enhance your protocol planning, strategic feasibility, and clinical trial launch. Our strategic clinical consulting will ensure your 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 your planned study, where recommended.
We provide:
1. Full protocol review, analysis, report of findings on objectives, endpoints, assessments planned.
2. Enrollment rate performance and enrollment rate analysis.
3. Expected site profile analysis. Site number guidance.
4. Country ranking analysis. Country selection guidance.
5. Competitive clinical landscape analysis for potential site-level and patient-level resource constraints.
6. FDA Project Optimus guidance, dose optimization considerations (as applicable).
7. Analysis of study’s expected patient and site burden.
8. Other analyses and tasks, as requested.
Oncology Trial Optimization
Working in close collaboration with your teams (in-person and/or remote) and any other consultants and external collaborators, we address the current competitive landscape that may compete for site resources and patient populations with your 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.
We provide:
1. Protocol consistency and optimization analysis.
2. FDA Project FrontRunner guidance (as applicable).
3. Analysis of ‘study attractiveness’ to sites and patients – scientifically, clinically.
4. Identification and outreach to potential sites and KOLs.
5. “Reverse” study feasibility.
6. Patient recruitment and retention strategies.
6. Risks identification and their mitigation strategies.
7. Regulatory landscape analysis.
8. Other guidance and tasks, as requested.