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Clinical Trial Management

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Our trial managers have extensive experience in setting up, budgeting and conducting Phase I through Phase III Clinical Trials

We will be responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables of clinical trials.

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Our Services Include:

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  • Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;

  • Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;

  • We perform site visit report review for assigned projects and tracks site visit report metrics to ensure compliance;

  • Contributes to the development of the Clinical Monitoring Plan;

  • Performs co-monitoring visits with CRAs;

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