Project Management

Our clinical project managers ensure that the deliverables are met on time and within the allocated budget.

Our Expertise

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Vendor Selection and Management

We support the sponsors with proposals and selection of vendors such as Institutional review boards, core imaging labs, central labs, and trial supply management companies. We also train the vendors prior to study initiation and once the study is activated, we manage the vendors to make sure that the project milestones and tasks are completed in a timely manner.

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Protocol Review

We review the protocol and provide an assessment on the required resources pertaining to timelines and budgets for each protocol required activity such as patient recruitment, regulatory, randomization, safety etc.

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ICF Development

We help sponsors and sites in crafting comprehensive, easy to read ICFs that comply with all the regulatory requirements. We also develop study specific and site specific ICF checklists.

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Budget

We do a careful review of the study assessment schedule and other sections of the protocol to create overall and site-specific budgets. Our expert teams use the standard of care and local costs to determine the budget for a particular location or site.

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Study Plans and documentation (Monitoring Plan, Project plan, communication plan etc.)

Our team has adaptable plan templates that are developed based on industry best practices. We use these templates to create study specific plans and templates. These plans also help the sponsors to follow high standards of practice in the conduct of clinical trials.

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ePRO/eCOA - Questionnaire Permissions and Licensing

We can support your trials with permissions and licensing of the Clinical Outcome Assessments. Our team has extensive experience in the licensing process for commonly used questionnaires across the therapeutic areas.