GRA provides support for Clinical Development and Monitoring activities in line with the ICH Efficacy guidelines.
We also provide Clinical Project Management services to coordinate the clinical development activities and perform clinical monitoring to ensure that trials progress smoothly, ethically and effectively.
Clinical Development: We aid clients with clinical trials and Clinical Research Organisation management, providing expertise for:
- Clinical Trial Design: designing clinical trial protocols with suitable trial structure, stastistical power with appropriate clinical endpoints.
- Regulatory Submissions: preparation and submission of documentation to the specific regulatory body for approval to conduct clinical trials.
- Briefing Booklet: preparation and submission of the clinical elements of the briefing booking for submission to the specific regulatory body.
- Clinical Assays: oversight of the design and validation of clinical assays to GCP standards and management of CRO activities including sample assessment.
- Site Selection and Management: identification and management of clinical trial sites to ensure suitable standards of conduct are met, including data collection and collation.
- Patient Recruitment: implementing strategies to recruit and retain patients, ensuring adequate enrolment to meet the clinical trial design.
- Data Management & Analysis: ensuring accurate and secure collection, storage, and analysis of clinical trial data and statistical evaluation.
Clinical Monitoring: We perform monitoring to oversee the conduct of the clinical trials to ensure compliance with regulatory requirements, protocol adherence and data integrity. GRA support clients with effective monitoring that maintains the quality and credibility of clinical trial results with:
- On-Site and Remote Monitoring: providing flexible monitoring solutions, including on-site visits and remote oversight, to ensure trial compliance and data integrity.
- Regulatory Compliance: ensuring that clinical trials adhere to Good Clinical Practice (GCP) guidelines and other regulatory standards.
- Data Verification: review of source documents and trial data to verify accuracy and completeness.
- Risk Management: identifying and mitigating potential risks to trial integrity and patient safety.
- Issue Resolution: addressing issues that arise during the trial, including protocol deviations.
Leveraging our expertise helps organisations navigate the complexities of clinical development and monitoring, ultimately accelerating and maximising the likelihood of successful clinical trials and regulatory approval.