In the complex process of clinical trials, audit supporting services are a professional service provided to ensure the authenticity, accuracy, completeness and compliance of trial data. The audit supporting services provided by our company will adhere to the service concept of "professional, efficient, and confidential" and aim to provide customers with comprehensive and professional quality assurance to ensure the high-quality conduct and completion of clinical trials.
**1. Service Overview**
Audit supporting services monitor the entire clinical trial process through a systematic approach to ensure that the trial process complies with laws, regulations and ethical requirements, the data is complete and accurate, and the results are reliable.
**2. Service content**
1. Formulate an audit plan: Based on the characteristics and requirements of clinical trials, formulate a detailed audit plan to clarify the audit objectives, scope, frequency and methods.
2. On-site inspection: Send professional auditors to the trial site to conduct on-site inspection and supervision of the trial process, including trial facilities, equipment, document records, subject management, etc.
3. Data audit: Conduct regular audits of clinical trial data to ensure the authenticity, completeness and accuracy of the data, including original data, case report forms, etc.
4. Problem tracking and rectification: For problems discovered during the audit process, the team will communicate with customers, researchers, etc. in a timely manner to track and rectify the problems to ensure that the problems are solved in a timely manner and avoid adverse effects on the test results.
5. Audit report preparation: Prepare a detailed audit report based on the audit results, objectively evaluate the test process, feedback the audit results and make suggestions for improvement.
**3. Service features**
1. Professionalism: Our auditors all have rich clinical trial experience and professional knowledge, and can accurately judge problems existing in the trial process and propose effective solutions.
2. Comprehensiveness: Our audit services cover the entire process of the trial, from trial design to data collection, analysis, report writing, etc., to ensure trial compliance and data quality.
3. Efficiency: We use advanced auditing tools and methods to improve auditing efficiency. The team will promptly make rectification suggestions for discovered problems and follow up on the rectifications to ensure that problems are solved in a timely manner and that the test progress is not affected.
4. Confidentiality: We strictly abide by confidentiality agreements to ensure that customer information and data are not leaked.
**4. Service value**
1. Improve trial quality: Through audit supporting services, we can ensure that the clinical trial process complies with laws, regulations and ethical requirements, the data is true and accurate, and the results are reliable, ensuring the compliance and data quality of clinical trials, and reducing the risks and costs of clinical trials.
2. Reduce risks: promptly discover and correct problems existing in the trial process, improve the clinical trial management level of customers and researchers, avoid adverse effects on trial results, and reduce customers' legal risks and economic losses.
3. Improve credibility: By providing high-quality audit supporting services, customers’ credibility and image in the field of clinical trials can be enhanced.