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> Clinical / Regulatory

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Clinical / Regulatory

 

VinCro has an extensive network of therapeutically diverse clinical research monitoring professionals throughout North America.  Our monitors are located both centrally and regionally which enables us to minimize travel expenses for our partners. We use appropriate information technologies in order to maintain effective communication between employees. Our network allows us to be flexible and responsive to the needs of our partners. The goal of our monitors is to provide clean accurate data for the study in a timely and efficient manner. Our dedicated staff of Regulatory Associates have experience in the preparation and submission of CTA's and CTAA's.

 

 

Clinical and Regulatory responsibilities at VinCro include:

  • Ensuring site compliance with guidelines and regulations

  • Study qualification visits

  • Study initiation visits

  • Study site monitoring and close-out visits:

  • Source document verification:

  • Management and resolution of site problems

  • Drug accountability reconciliation

  • Regulatory document maintenance

  • Site management activities:

  • Study visit correspondence

  • Routine telephone contacts

  • Maintenance of study tracking tools

  • Maintenance of study materials

  • Manage patient recruitment and retention

  • Data query resolution

  • Regulatory:

  • CTA Preparation

  • CTA-A Preparation

 

 

 

 

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