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Vendor Selection and Management

As the outsourced clinical research trend continues to grow, so does the need to develop an effective vendor selection and management strategy. For many companies that includes working with a clinical research organization (CRO) as a cost-effective and efficient way to gain vendor relations expertise and experience without increasing overhead.

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At MEDIcept, our vendor selection team conducts a detailed vetting process to carefully qualify vendors prior to selection, according to quality standards. During the course of the clinical trials, our team uses effective tools and techniques to efficiently manage vendors while addressing risk management and ensuring successful third party vendor partnerships. Our proven process for selecting and managing vendors helps our clients keep their clinical trials on track and on budget.

Unmatched vendor resources.

We can support your clinical study team with vendor selection and contracting, defining and implementing quality metrics with your vendor partners, and auditing clinical service providers in line with the current regulatory requirements and inspection trends.

MEDIcept has developed long-term, strategic partnerships with a wide range of trusted vendors such as laboratories, Imaging, Central Readers, and Clinical Trial Systems Providers to support your clinical trials.

We can provide complete clinical infrastructures for:

  • EDC
  • eTMF
  • CTMS
  • eDiary/ePRO
  • IxRS
  • eConsent
  • Telehealth
  • Safety monitoring and management

Experience and expertise.

Our vendor management team is highly skilled and experienced at controlling cost, reducing potential vendor-related risks, and ensuring both optimal vendor service and value. They understand each vendor’s internal processes to streamline and effectively manage interactions between them and your clinical trial team. Regular project management meetings and timely responses to issues, inquiries, and other communications help ensure a successful trial outcome.

From managing relations with multiple vendors to gauging quality of work and evaluating performance using organizational standards, our goal is to help establish and grow strong vendor/sponsor partnerships that will lead to successful projects and long-term relationships.

I need help NOW!

Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.

Need FDA or EU MDR/IVDR audit assistance?

Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.

Are you a start-up?

We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.