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Contract Research Organization Procurement and Management

CRO Procurement and Management

Advantage Clinical offers support for small and emerging biopharma and biotechnology companies to help them find the partner of choice to bring their new ideas to life.

Bringing a new therapeutic to life can be a long, arduous and difficult process. Good news is, we’ve been down this road before and we want to help you navigate your way to market. It’s not something any of us can do on our own. We need help to find the right team of experts to help us and luckily our industry has this figured out. Introducing Contract Research Organizations….

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Contract Research Organizations (CROs) are the workhorses of the clinical research industry providing a range of services, expertise and resources to help you bring your ideas to life. As of 2024 there are over 4500 CROs around the world offering drug and device development services and that number is growing faster than we can track. With the recent explosion in CROs, choosing the right partner can be like looking for a diamond in the rough. Each and every CRO can bring a unique set of skills, experience, expertise and capabilities to the table. We are here to help you find the one the one that is right for you. Not too hot, not too cold…just right!

Think of us as the matchmaker of the clinical research world. We will take the time to deeply understand your needs, wants, objectives and capabilities and work with you to find your long term partner in drug / device development.

Once the match is made Advantage Clinical is here to stay, and help to support a long term and mutually beneficial relationship between your firm and the CRO. Our goal is to support and foster long term sponsor and CRO relationships to help bring lifesaving therapies to market; to the patients who need them most. That’s why we are all here after all, isn’t it?

For more information on our CRO selection and management services please watch the video and view the links below. We are excited to learn more about your exciting projects and see if we might be able to help you along the way to saving lives.

Advantage Clinical is focused on bridging the gap between you and the world of clinical trial delivery. We offer a suite of services to help you choose the right Contract Research Organization partner and act as your advocate during the life of your clinical development journey.

Below is a snapshot the services we offer to our partners and we won’t stop there. We will do what it takes to ensure your receive the best service from your clinical delivery partners.

Whether you are currently contracted with a CRO or are looking to start the process of finding the right one, we are here to help.

CRO Selection:

At advantage clinical, we represent your organization throughout this process. We keep your goals front of mind and advocate for your interests through the clinical development journey.

Needs Assessment

Clinical trial protocol support, assessment, and review
Needs and internal capabilities review of your organization
Resource gap analysis
Review of expected timelines for project delivery
Prepare customized vendor scorecard to assess candidates and vendors

Request for Information (RFI) Management

Prepare listing of CRO Candidates
Prepare RFI Requests
Distribute to CRO Candidates
Collate responses and present recommendations
Client selects final CRO candidates

Proposal Management

Prepare Request for Proposal (RFP)
Invite selected CRO candidates to submit proposals
Non-disclosure agreement management
Manage CRO correspondence throughout the proposal cycle
Respond to questions and prepare addenda as required
Collate responses and score using customized scorecard
Prepare and present recommendations
Client selects CRO candidates to present bid

Bid Defense Management

Invite selected CROs to present bids
Manage logistics of bid defense meetings
Attend and moderate bid defense meetings
Advocate for your organization throughout the bid process
Liaise with CRO and internal stakeholders throughout bid process
Analysis of proposed CRO budget and lead negotiation of line items
Manage follow up communications with CRO candidates for additional information
Conduct interviews with CRO proposed project team members
Conduct CRO reference checks
Finalize candidate scoring and narratives
Present recommendations and full reports on top candidates
Communicate client decision to all candidates

CRO Management:

Study Launch

Act as liaison between your organization and the CRO
Work with your legal team during Start Up Agreement (SUA) and Work Order (WO) negotiations
Attend / moderate project kick off meeting
Review of project plans, schedule and other project management items prepared by the CRO

Study Operations

Attend / moderate all project meetings with the CRO
Ensure your advocate throughout the project lifecycle
Ongoing review / management of project metrics
Review / Management of project documents
Ensure CRO sticks to proposed timelines and milestones
Manage CRO performance and liaise with CRO senior management if project falls behind
Integrate with CRO teams as your advocate to ensure the project is delivered as promised
Quality and Risk management
Work with CRO to maximize patient recruitment efforts
Issue study performance reports for your stakeholders