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 the services and activities related to clinical research and trial management. It serves as a roadmap for achieving and maintaining quality in all aspects of the company operations, from protocol development to data management, to ensure the reliability and integrity of clinical trial outcomes
Audit Plan
The audit plan serves as a vital roadmap for conducting a thorough, objective, and compliant evaluation of the clinical trial, helping to ensure data integrity, patient safety, and regulatory adherence. It provides a structured framework for auditing activities and reporting, facilitating the continuous improvement of clinical trial processes.
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 Actaphase this involves the following key elements:
- Preparation: Before the audit, our auditors review relevant documents, including the study protocol, informed consent forms, and site-specific files, to understand the trial’s context.
- On-Site Visit: We conduct a physical visit to the investigational site to observe operations, verify data, and interview site personnel. This provides a firsthand assessment of site practices.
- Data Verification: We verify the accuracy and completeness of trial data by comparing source documents with case report forms (CRFs) or electronic data capture (EDC) systems.
- Compliance Assessment: We assess the site’s adherence to the study protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This includes evaluating informed consent procedures, documentation, and safety reporting.
- Documentation Review: Our auditors examine records and documents related to the trial, such as subject enrollment logs, regulatory submissions, and communication records with sponsors and ethics committees.
- Interviews: We conduct 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: We document any non-compliance issues, deviations, or deficiencies identified during the audit. Distinguish between critical findings that could impact patient safety or data integrity and non-critical findings.
- Report Preparation: We compile the audit findings and observations into a comprehensive report, which includes a summary of the audit, identified issues, and recommendations for corrective actions.
- Corrective Action Follow-up: We track and verify the implementation of corrective actions by the site in response to audit findings. We ensure that issues are adequately addressed and resolved.
- Audit Closure: At the end, we conclude the audit by providing a final report to the site and relevant stakeholders. We acknowledge the satisfactory resolution of issues or outline any outstanding concerns.
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, ultimately ensuring that they contribute effectively to the success of the clinical trial.
Quality Management System (QMS)
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 can provide a range of services related to QMS – some key services include: 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, and other.
Standard Operating Procedures (SOP) Development
SOP development involves the creation and documentation of 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.
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. Actaphase offers an excellent CAPA development service that includes:
- Thorough Assessment: A comprehensive analysis of issues and non-compliances to identify root causes.
- Effective Corrective Actions: The development of actionable plans to address immediate issues and mitigate their impact.
- Robust Preventive Actions: The creation of preventive measures to prevent recurrence and improve overall quality.
- Regulatory Compliance: Ensuring that 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 that CAPAs are effective in preventing future issues.
- Continuous Improvement: Incorporation of lessons learned into future processes