OCT project management offers professional expertise in the crucial skills of planning, relationship building, and communicating.
We recruit experienced CRAs both in-house and field-based. OCT study monitors are specifically trained in the complexities of the multidisciplinary trial environment. Their services include:
- Monitoring study progress
- Source document reviewing and verification
- Confirming patient eligibility
- Tracking patient compliance
- Maintaining various databases
- Managing study supply inventories
- Reporting adverse events
- Monitoring regulatory compliance
- Maintaining regulatory documentation
Site visits provide the opportunity to discuss recruitment strategies and potential problems and to compile direct feedback on performance.
Quality Control comes about through the strict adherence to the ICH GCP requirements, SOPs used in the study and all applicable local authority regulations.
As a rule, we perform Quality Assurance Audits to achieve maximum quality of the study data. Usually, up to 10% of monitoring activities are controlled by means of co-monitoring.
Our project coordinators ensure the following:
- Assistance in selecting research centers, contacting potential research centers and performing their joint appraisal, pre-study site assessment;
- Preparing sponsors visit to the research center;
- Assistance in coordinating activities of the researchers;
- Compiling and forwarding to the sponsor the required documents from the research site and vice versa;
- Ongoing contacts with the entire team of investigators and administration of the research centers.
