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Services and Capabilities
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
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Clinical trial protocol support, assessment, and review
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Needs and internal capabilities review of your organization
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Resource gap analysis
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Review of expected timelines for project delivery
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Prepare customized vendor scorecard to assess candidates and vendors
Request for Information (RFI) Management
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Prepare listing of CRO Candidates
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Prepare RFI Requests
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Distribute to CRO Candidates
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Collate responses and present recommendations
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Client selects final CRO candidates
Proposal Management
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Prepare Request for Proposal (RFP)
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Invite selected CRO candidates to submit proposals
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Non-disclosure agreement management
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Manage CRO correspondence throughout the proposal cycle
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Respond to questions and prepare addenda as required
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Collate responses and score using customized scorecard
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Prepare and present recommendations
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Client selects CRO candidates to present bid
Bid Defense Management
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Invite selected CROs to present bids
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Manage logistics of bid defense meetings
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Attend and moderate bid defense meetings
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Advocate for your organization throughout the bid process
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Liaise with CRO and internal stakeholders throughout bid process
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Analysis of proposed CRO budget and lead negotiation of line items
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Manage follow up communications with CRO candidates for additional information
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Conduct interviews with CRO proposed project team members
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Conduct CRO reference checks
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Finalize candidate scoring and narratives
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Present recommendations and full reports on top candidates
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Communicate client decision to all candidates
CRO Management:
Study Launch
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Act as liaison between your organization and the CRO
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Work with your legal team during Start Up Agreement (SUA) and Work Order (WO) negotiations
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Attend / moderate project kick off meeting
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Review of project plans, schedule and other project management items prepared by the CRO
Study Operations
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Attend / moderate all project meetings with the CRO
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Ensure your advocate throughout the project lifecycle
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Ongoing review / management of project metrics
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Review / Management of project documents
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Ensure CRO sticks to proposed timelines and milestones
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Manage CRO performance and liaise with CRO senior management if project falls behind
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Integrate with CRO teams as your advocate to ensure the project is delivered as promised
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Quality and Risk management
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Work with CRO to maximize patient recruitment efforts
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Issue study performance reports for your stakeholders
Financial Elements
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Review of CRO billings against agreed budgets / milestones
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Manage Change Order negotiations with CRO, maximizing your return on investment
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Review of Investigator Grant payments
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Review of all pass through costs including third party vendors
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Track CRO performance against SUA / WO
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Issue financial performance reports for your stakeholders