Clinical Study Management

Clinical trials are complex and require effective coordination and management at all stages.

Our Clinical Study Managers offer expert project management support throughout your research project. With extensive experience in managing national and international studies of varying size, duration, and complexity, our team provides essential support to researchers during the clinical trial process.

We ensure the smooth operation of your study by overseeing and coordinating every aspect, from planning to execution. Our focus is on achieving project milestones and closely monitoring recruitment rates, completeness of documentation, timelines, and budgets while maintaining compliance with scientific and regulatory standards. By facilitating ongoing communication among stakeholders, we ensure consistent project progress and success.

Why not let our experienced team guide your project to success? Our service is tailored for smaller research teams, offering expert study management where it may be lacking in your group. With extensive external expertise across all aspects of study planning and execution, we enhance your project, especially when your team could benefit from additional outside input.

Our Services

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Document development

We assist in creating all necessary study documents, including the study protocol and participant information documents, ensuring clarity and compliance with regulatory standards.
Trial Master File setup and maintenance We establish and manage the Trial Master File, maintaining organized and up-to-date documentation throughout the study to support regulatory compliance and efficient study conduct.
Submissions to ethics committees and regulatory authorities We handle the entire submission process to obtain approvals from ethics committees and regulatory authorities. Our support continues throughout the study, assisting with regulatory reporting tasks to ensure ongoing compliance.
Site management We facilitate the onboarding of study sites, from initial contact and feasibility assessment to signing the clinical study agreement. We continue to manage and support participating sites throughout the study, ensuring efficient and effective operations.
Timeline and budget management We oversee project timelines and budgets, ensuring that your study stays on track and within budget, enabling successful and timely completion.
Project status reporting We provide regular reports on the status and progress of your study, keeping you informed every step of the way.
Risk management We identify and mitigate potential risks to the success of your study, ensuring smooth operations and adherence to all regulatory requirements.