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Services

CRA Liaison for your remote monitoring activities

Narrative writing

Clinitude has a team of experienced narrative writers. Clinitude can help you with your adjudication needs. Event related documents are processed digitally. Our team tracks this documentation and ensures that all is linked with the relevant event that requires adjudication. Potential trial endpoints are captured in a trial database.

Site Management, Site Monitoring and Remote Monitoring

Our CRAs and CRA liaisons ensure proper planning, conduct, patient safety and data quality while maintaining a good communication with sites and sponsors. Our CRAs and CRA Liaisons work closely with your team on protocol training, building strong relationships and ensuring site compliance. We adhere to a high standard of quality, ICH-GCP guidelines and local regulations. Our CRA team and CRA Liaison team is skilled in risk based monitoring.

Regulatory Submissions

Clinitude provides a professional, personalized approach to our regulatory services, submissions and clinical trial document review. Clinitude’s standard operation procedures assure adherence to ICH-GCP and local regulatory standards. We are experienced in managing, reviewing and compiling regulatory dossiers.

Project Management

Our Project Managers work together with you from the beginning to make sure that every aspect of a project is planned for and executed precisely. Project Managers review project progression, risk assessment – mitigation and completion. Our goal is to complete your project on time and within budget while maintaining the high quality of our services.

Project Managers are responsible for team and time management, budget management. They will report the project status at regular timepoints. Clinitude focuses on risk management and mitigation and our project managers are involved in this process from the start.

Clinitude’s Project Managers provide leadership and direction to the project team.

Feasibility and Site/Investigator Selection

Selecting the correct investigational site for your project is a very conscious process. Clinitude has built a network of KOLs in several fields. Project Manager and CRA work closely together to ensure a proper feasibility and selection process. They make sure that a country/site can be selected as soon as possible to ensure a proper start of your study. They will make that the investigational site meet the requirements for your clinical trial. This includes high quality, available potential patients, necessary facilities and expertise and motivated investigators with a dedicated team.

Clinitude can assist in developing the feasibility questionnaire.

Clinical Research Transformation Services

Clinitude can help you transform your strategy for budget management and cost reduction, business needs and resource planning. The Clinical Research Transformation specialist utilizes the knowledge and skills of the clinical research industry to determine clinical functions and to ensure that your systems are consistent with professional standards.