A. Quality Plan
A Quality Plan is a comprehensive document that outlines the strategies, processes, and standards for maintaining and ensuring the highest level of quality, accuracy, and regulatory compliance in services and activities related to clinical research and trial management. It serves as a roadmap for achieving and maintaining quality in all aspects of company operations, from protocol development to data management, ensuring the reliability and integrity of clinical trial outcomes.
B. Audit Plan
The audit plan is a crucial roadmap for conducting thorough, objective, and compliant evaluations of clinical trials, ensuring data integrity, patient safety, and regulatory adherence. It provides a structured framework for auditing activities and reporting, facilitating continuous improvement of clinical trial processes.
C. Site Audit
An effective site audit is a thorough and systematic examination of a research site’s processes, data, and compliance with regulatory requirements. At GCT, this typically involves:
Preparation
Reviewing relevant documents, including the study protocol, informed consent forms, and site-specific files, to understand the trial’s context.
On-Site Visit
Conducting a physical visit to the investigational site to observe operations, verify data, and interview site personnel for a firsthand assessment of site practices.
Data Verification
Verifying the accuracy and completeness of trial data by comparing source documents with case report forms (CRFs) or electronic data capture (EDC) systems.
Compliance Assessment
Assessing the site’s adherence to the study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines, including evaluating informed consent procedures, documentation, and safety reporting.
Documentation Review
Examining records and documents related to the trial, such as subject enrollment logs, regulatory submissions, and communication records with sponsors and ethics committees.
Interviews
Conducting interviews with site personnel, including investigators, coordinators, and other key staff members, to gather information and assess their understanding of trial procedures.
Findings and Observations
Documenting any non-compliance issues, deviations, or deficiencies identified during the audit, distinguishing between critical findings that could impact patient safety or data integrity and non-critical findings.
Report Preparation
Compiling the audit findings and observations into a comprehensive report, including a summary of the audit, identified issues, and recommendations for corrective actions.
Corrective Action Follow-up
Tracking and verifying the implementation of corrective actions by the site in response to audit findings, ensuring that issues are adequately addressed and resolved.
Audit Closure
Concluding the audit by providing a final report to the site and relevant stakeholders, acknowledging the satisfactory resolution of issues or outlining any outstanding concerns.
D. Vendor Audit
A vendor audit in a clinical trial is a systematic evaluation of third-party service providers, such as laboratories, data management companies, or central laboratories, to ensure they meet the required quality and regulatory standards. The audit aims to assess the vendor’s capabilities, performance, and adherence to contractual obligations, ensuring they contribute effectively to the success of the clinical trial.
E. SOP System
We offer a range of services related to Standard Operating Procedure (SOP) systems designed to help you establish, maintain, and optimize your SOP systems for clinical trials and research activities.
Our services include:
SOP Development
Assistance in developing customized SOPs tailored to your specific research needs, ensuring alignment with industry regulations and best practices.
SOP Review and Revision
Periodic review and updates of existing SOPs to stay current with evolving regulations and guidelines.
SOP Training
Training programs to educate your staff on proper implementation of SOPs, ensuring all team members understand and follow established procedures.
Quality Assurance and Compliance
Audits and assessments to evaluate adherence to SOPs and regulatory requirements, identifying areas of non-compliance and recommending corrective actions.
SOP Implementation
Practical implementation of SOPs across your organization, ensuring procedures are effectively put into practice.
Documentation Management
Establishing systems for efficient documentation management, including electronic document management solutions, version control, and archiving.
Risk Assessment and Management
Performing risk assessments to identify potential gaps or weaknesses in your SOP system and developing strategies for mitigating risks.
Continuous Improvement
Establishing processes for ongoing SOP improvement, including feedback mechanisms and periodic reviews.
Regulatory Compliance Support
Guidance and support to ensure SOPs align with regulatory requirements and are audit-ready.
Audit Preparation
Preparing for regulatory inspections and audits by conducting mock audits, helping gather necessary documentation, and training staff on how to respond to auditors.
Technology Integration
Integrating technology solutions, such as electronic SOP management systems, to streamline SOP-related processes.
Consultation and Expertise
Providing expert consultation and advice with experienced professionals knowledgeable in regulatory requirements and industry best practices.
F. Quality Management System (QMS) Audit
A Quality Management System (QMS) is a structured framework of documented processes, procedures, and practices designed to ensure the highest level of quality, regulatory compliance, and efficiency in all aspects of clinical research and trial management services.
We offer a range of services related to QMS, including:
- QMS Implementation
- SOP Development and Review
- Regulatory Compliance Support
- Quality Auditing
- Training Programs
- Data and Documentation Management
- Risk Assessment and Mitigation
- Quality Control (QC) Services
- Regulatory Inspections Preparation
- Vendor and Site Auditing
- Quality Metrics Reporting
G. Trial Master File (TMF) Audit
A Trial Master File (TMF) audit involves a systematic examination and assessment of the trial master file, which is a comprehensive record of all essential documents related to a clinical trial. This service ensures that the TMF is complete, accurate, and compliant with regulatory requirements and industry standards. The audit helps identify and rectify any discrepancies or deficiencies in the TMF, ensuring data integrity and regulatory adherence throughout the trial’s lifecycle.
H. Standard Operating Procedures (SOP) Development
SOP development involves creating and documenting Standard Operating Procedures (SOPs) that outline specific processes and procedures related to clinical trials and research activities. These SOPs are customized to meet your needs and are designed to ensure consistency, compliance with regulations, and best practices throughout the research process.
I. CAPA Development and Implementation
CAPA (Corrective and Preventive Action) development and implementation refers to the systematic process of identifying, addressing, and preventing issues and non-compliances to improve the quality and compliance of clinical trial operations. GCT offers a comprehensive CAPA development service, including:
Thorough Assessment
Comprehensive analysis of issues and non-compliances to identify root causes.
Effective Corrective Actions
Development of actionable plans to address immediate issues and mitigate their impact.
Robust Preventive Actions
Creation of preventive measures to prevent recurrence and improve overall quality.
Regulatory Compliance
Ensuring CAPA plans align with regulatory requirements and industry best practices.
Documentation
Comprehensive documentation of CAPA plans, implementation, and verification of effectiveness.
Timeliness
Prompt execution of CAPA plans to minimize potential risks and disruptions.
Monitoring and Verification
Ongoing monitoring and verification to ensure CAPAs are effective in preventing future issues.
Continuous Improvement
Incorporation of lessons learned into future processes.