Request for Information (RFI): “Get to know your provider”
The purpose of the RFI is to gain the maximum information about potential partners (contract research organizations – CROs) and determine if they have the capabilities to be included in a more formal request for proposal (RFP) process. Receiving information from the partners might not be enough. The sponsor should ideally invite partners for a formal presentation.
During the RFI process, sponsors should identify which CROs should receive the RFP and what information should be gleaned from each.
Which CROs should receive the RFI? CROs different sizes – different strengths
CRO partners are basically classified as large, mid-size and small, all of whom possess different strengths. A survey conducted by The Avoca Group in 2011 revealed a close correlation in the size of a sponsor company and the size of the CRO. In fact small and mid-sized sponsors tended to dedicate their outsourcing mainly to small (beyond Top 15) and mid-sized CROs (or specialty CROs).
What information should be gleaned?
When requesting information or when inviting the partner for a presentation, sponsors should include a brief background on the organization and pipeline, in order to guide prospective partners through the process. Essentially, the following information should be requested:
- CRO corporate overview
- Drug/Medical device experience
- Therapeutic experience
- Trial type experience
- Staff training, continuing education and turnover
- Regulatory expertise
- Current and former client references
Define your Outsource Strategy: Do your homework
From the start, define what kind of vendor you’re looking for– a preferred provider or project specific vendor? Full service or functional service provider? Sponsors should define the services they need to complement their internal resources. Determine what core competencies you need to manage the outsourcing process, as well as the relationship with the CRO. Ideally you should set your oversight management plan (i.e. how much do you want to be involved during the clinical trial? Site visits, investigator relationship, meetings, data review etc.).Define your outsourcing budget and implement a CRO evaluation team
Potential partners pre-Selection: What type of CRO would fit the project/the company?
Based on the RFI responses received, create a shortlist of CROs to move to the next phase. The creation of this list should be guided by one key question: What type of CRO would fit the project/the company? Assess the below parameters:
- Expertise: Does the CRO have the expertise to undertake the duties the sponsor requires?
- Compatibility: Can the CRO fulfill its duties in a manner that is compatible with the sponsor (i.e., is there a good fit)?
- Capacity: Does the CRO have the ability to commit the manpower and resources needed in the Sponsor’s timeframe?
RFP Content and Related Documents
The RFP initiates business discussion and defines the sponsor-defined tasks on which you bid. The more details included in the RFP, the more accurate the bid. The sponsor should provide key information, such as background information on the compound, a protocol summary, specific project timelines, a schedule of assessment, and which clinical services they need.
An inadequate document leads to inconsistencies among bidders, a poor project, bad budget management and a problematic relationship between the sponsor and the selected vendor. (Debora Dongo-Soria, 2015 clinicaltrialarena.com)
Avoid sending an isolated protocol synopsis or emails with minimal information to the CROs. You have to write/compile your full RFP document. This document must contain at least:
- Purpose of the Request for Proposal (RFP) and project/sponsor Background
- The scope of the project
- Study Objectives
The sponsors should provide some guidance about the RFP process and their expectations, especially for project management and meetings. The other element, such as key bidding assumptions, clinical trial services and responsibilities, and pricing should be detailed in the Bid Grid.
Bid Grid: The Key to the Proposal
Usually compiled in an excel workbook with three sheets – Study Assumptions; Tasks and Responsibility Matrix, and the Budget
Study Assumptions: Details — The More the Better
This section should provide the maximum information and should describe the study requirements. The content should include but not be limited to:
- Study design and phase
- Number of subjects (screening, randomize and completers)
- Study timelines (enrolment, treatment durations, end of Study timelines)
- Countries and Sites
- Project Management and Monitoring strategy
- Start-up and Regulatory
- Contract/Legal Services
- Medical Writing
Sponsor should allow prospective CRO partners to provide comments on the study assumptions.
Tasks and Responsibility Matrix: Who does what?
The sponsor should provide the list of study activities and clearly specify the responsibilities among the parties involved (i.e. Sponsor, Clinical CRO and any third party vendor).
The Budget: Precision and Clarity
The budget is often the source of conflict between the sponsor and the selected vendor. Therefore get it right from the beginning. The budget sheet must contain all the study activities, with maximum details including a section for pass-through cost.
For the costing purpose, for each task the sponsor should describe the unit. The prospective CRO partner should provide an accurate cost by including the number of unit requested per task, the cost of each unit, and the time needed to achieve one unit. This should lead to a clear cost per task.
The total project cost should clearly specify the CRO direct cost, the pass-through cost, any discount, and the total cost.
Your RFP should contain:
- RFP document
- Bid Grid (i.e. Study Assumptions; Tasks and Responsibility Matrix; Budget)
- Study Synopsis including the Schedule of assessment
The RFP is a very important process that initiates business with a partner. Therefore, as described by Brad Anderson, there are five mistakes to avoid when preparing the RFP:
- Lack of proper preparation
- Omitting vital information
- Not verifying CRO qualifications
- Over reliance on bid grids
- Failure to properly evaluate pricing
However, to achieve the best RFP, sponsors must clearly describe their needs in the RFP that will allow the CROs to develop a realistic project proposal and accurate budget
Associate Director – Clinical Studies
VECTURA UK LIMITED
1) The Avoca Group: 2011 Avoca Clinical Outsourcing and Relationship Management Survey: Sponsor Needs and Challenges in Clinical Development Outsourcing Executive Summary, 2011
2) Debora Dongo-Soria, Planning your RFP; Clinical Trials Arena, 2015
3) Brad Anderson, Top 5 Mistakes of RFP Writing; Applied Clinical Trials, 2009