DigiPlus

List of the contents of this article:

• 1,DigiPlus Clinical trial data management system CDMS What are the leading international products now?
• 2, What is the clinical trial data management system?
• 3, EDC system clinical trial data management system which is better
• 4, All steps involving clinical trial data management only need to be operated according to the standard

3. That is, EDC System (Electronic Data Capture System) is a platform software suitable for clinical trial data collection and transmission. The EDC system can be integrated with other clinical trial-related systems, such as the central random system, project management system, etc., and become the core management platform for clinical trial projects.

What is the clinical trial data management system?

QMS is an integral part of the clinical trial project management system. Responsibilities and authority of relevant personnel;Implement the concept of quality management into the daily work of data management.

Recommend a very good system: CTBlazer clinical trial data management system, which is an innovative generation of clinical trial data management system, strictly following the SOP process and SFDA's GCP regulations.

It refers to a system used to recruit volunteers and randomly assign participants during clinical trials. Random allocation is to avoid deviations in experimental results and improve the scientificity and reliability of experiments.

Which is the best clinical trial data management system of the EDC system

1. The EDC system developed by Xi'an Lynn Company is very good, which can be a clinical trialVerification Research provides EXCEL quick library construction, questioning classification management, support for batch data cleaning, audit trajectory - audit tracking, built-in retrieval of generic names of drugs, visit reminders and other functions, which can help researchers better complete clinical project research.

2. Recommend a very good system: CTBlazer clinical trial data management system, which is an innovative generation of clinical trial data management system, strictly following the SOP process and SFDA's GCP regulations.

3. When I participated in a project before, I came into contact with the Ryan edc system. Their system is quite easy to use. The data format and structure meet the CDISC standards. Users can also customize the construction according to their own actual needs, which is very helpful for planning and controlling the test process. .

All steps involving clinical trial data management should be operated in accordance with the standard

Before conducting clinical trials, the applicant must provide preclinical research data of experimental drugs, including prescriptions. Composition, manufacturing process and quality inspection results.

Article 2 The standard for the management of drug clinical trials is the standard provision for the whole process of clinical trials, including program design, organization, implementation, supervision, inspection, recording, analysis, summary and reporting. Article 3 All drugs that carry out various phases of clinical trials, including human bioavailability or bioequivalance tests, shall be implemented in accordance with this specification.

Article 2 The quality management standard for drug clinical trials is the whole process of drug clinical trials.The quality standards include program design, organization and implementation, supervision, inspection, recording, analysis, summary and reporting.

Article 53 The purpose of data management is to include the test data into the report quickly, completely and without error. All steps involving data management need to be recorded in order to check the data quality and test implementation. Use appropriate procedures to ensure the confidentiality of the database, and there should be maintenance and support procedures for the computer database.

The steps and tasks of data management should be clearly introduced in the clinical trial plan as follows: When the trial plan is formulated, the key links and data should be clearly protected to protect the rights and interests and safety of subjects and ensure the reliability of clinical trial results.