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4 Tips for Planning the RFP Process for Clinical Trial Services

Posted by Jamie Hahn on Tue, Aug 14, 2012 @ 02:49 PM
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gearheadBefore you request bids from contract research organizations (CROs) for clinical trial services, it’s important to spend time planning your request for proposal (RFP) process. It’s easy to neglect this planning step, especially since the other deadlines and pressures of the drug development and/or research process often take precedence. However, even the smallest amount of planning prior to the RFP process can reduce the amount of time you spend reviewing proposals and increase your ability to request clarifications from participating CROs.  

Here are some things to consider prior to the RFP process for clinical trial services:

1. Give the CROs at least 5-10 days to provide a bid. Plan ahead so that you can do this. The more time allowed for CROs to respond, the more complete and thoughtful the responses will be.

2. Determine a timeline for the RFP process, including: 

  • Due date for questions about the RFP from CROs.
  • Due date for your responses to the CRO questions.
  • Due date for responses to your RFP.
  • Date for the completion of your review of all CRO responses.
  • Dates for bid defenses for all contending CROs.
  • Date for final decision on selected CRO.

3. Determine selection criteria and provide that information to the CROs. For example, “The CRO will be selected based on responses to this RFP and the following criteria:

  • Quality of the response to RFP, including the quality of comments and suggestions.
  • Experiences/skill level of company representatives assigned to this project.
  • Quality and applicability of proposal presentations at bid defense meeting.
  • Demonstrated understanding of the indication.
  • Well-developed strategies for avoiding or effectively managing common drug development and clinical trial hurdles.
  • Value for the cost of service proposed.
4. Consider how you plan to receive and respond to CRO questions – Individually? As a group? In any format? In a prescribed format? We recommend providing a template and sending all the questions and answers to all participating CROs.
What else have you found useful in the RFP process? What would you add to our list?

 

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Contract Research Organization Getting You Down? 9 Tips for a Smooth Transition

Posted by Brook White on Thu, Jun 28, 2012 @ 09:38 AM
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contract research organizationIf you’ve been disappointed by your current contract research organization (CRO) you may want to transition your clinical trial or development program to another CRO. These tips can help make the transition as smooth as possible.

Creating a transition plan that accounts for the objectives and concerns of all stakeholders—you (the Sponsor), the existing CRO, the new CRO, study sites, and other providers (e.g. drug supply vendor, central labs, central IRBs) can make this difficult task easier. 

In our experience, the following areas are of primary concern when transitioning projects:

1.  Established, clear and realistic goals for the transition process.

2.  The existing CRO’s cooperation in transition process.

3.  Ensuring data and information transfers are accurate and complete.

4.  Assessing potential roadblocks and implementing preventive processes and solutions.

Work with the new CRO to accomplish the following early in the process:

5.  Conduct a comprehensive analysis of existing issues and challenges.

6.  Establish a communication plan for the initial transition.

7.  Establish a transition leader committed to a seamless transfer to act as a central point of contact.

8.  Assess the transitioning CRO’s systems, processes, and quality.

9.  Create a transition plan to be approved by all key stakeholders.


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5 Tips for Creating a Request for Proposal (RFP) for Clinical Trial Services

Posted by Jamie Hahn on Tue, Jun 05, 2012 @ 11:46 AM
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tool for clinical trial servicesIf you’re looking for a contract research organization (CRO) to provide clinical trial services, chances are you’ll need to create a request for proposal (RFP). In the complicated world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs can be incredibly challenging. The good news is, with a little planning and time, you can create RFPs that will reduce inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.

Here are five tips for creating RFPs that will help you compare “apples to apples” and help the CROs better understand your needs, values, and selection criteria for your clinical trial services:

1. Provide background info on your compound and program

2. Provide a protocol or protocol synopsis

3. Provide detailed RFP information to get consistent costs. Be specific. Some examples, might include:

  • Project specifications – What are the important details of your program? (Use our RFP specifications tool)
  • Project timelines – By when do you expect certain milestones to be met?
  • Responsibilities (CRO, sponsor, other vendors) – For which segments of your program do you need a CRO to provide clinical trial services?

4. Provide additional details. The more details you can provide the better.  It’s also OK to ask the CRO to make recommendations. You can tell a lot about a CRO by the recommendations they make and how they make them.  However, if you ask CROs to make recommendations be prepared for potential inconsistencies in the assumptions made and pricing offered between different CROs. The following are some additional details that might be helpful to bidders:

  • Paper or EDC?
  • Data output in CDISC format?
  • Provide site locations
  • Central or local labs?
  • Additional vendors (specialty labs, IRBs, translations, etc)?
  • Interim analyses, DSMBs, etc?
  • Automated subject randomization and clinical trial material re-ordering and shipping?

If you know you want to use certain specific vendors (i.e. you know you want to use Medidata RAVE for EDC), be sure to include that information.

5. Other items to request from CROs:

  • Project team CVs
  • Summary of team therapeutic experience and experience running similar trials
  • Relevant company information

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