Boyds provide comprehensive clinical management services to ensure studies are compliant with protocols and overall clinical objectives, delivered on time to clients programme schedule and within the agreed budget targets.
Our experienced team works with clients to plan, implement, track and coordinate clinical research projects from study start-up through to study close out. With detailed knowledge of regulatory requirements, our team ensure compliance with guidelines such as International Conference on Harmonization (ICH) guidelines for Good Clinical Practice (GCP), as well as ethical considerations such as patient confidentiality and informed consent.
Our team have the skills and expertise to play a critical role in the successful implementation of your clinical trial, ensuring that they are conducted in a timely and ethical manner, and that they produce high-quality data that can be used to inform medical decisions and improve patient outcomes.
Clinical project management includes:
- Developing project plans and timelines
- Identifying risks and issues
- Review study protocols and identify any problems, seeking revisions where appropriate Coordinating the communication between different stakeholders
- Identifying study sites and completing site contracts and budgets
- Compiling information and documentation for Research Ethics Committee submission
- Ensuring project milestones are met
- Maintain records of study activity and overseeing the training of study staff
- Monitor study progress and data collection, ensuring compliance with protocols with all regulatory agencies
- Oversee patient subject enrolment activities, assisting with overcoming recruitment challenges
- Prepare for and participate in quality assurance audits
- Assist in the interpretation and reporting of study data
- Budget review and management