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Clinical trials are a crucial stage in the research and development of drugs/medical devices and an important means of improving the development level of medical science and technology.
Published Time:
2020-08-21
Clinical trials are a crucial phase in the drug/medical device development process and a vital means of advancing medical science and technology. Achieving standardized management of clinical research, simplifying research processes, enabling researchers to better implement standard operating procedures, improving research quality and level, ensuring accurate, reliable, and scientifically credible trial results, thereby effectively shortening the new drug development cycle and accelerating drug registration, has become key for new drug development organizations to gain a foothold in the market and outcompete rivals.
In traditional clinical research, drug/medical device development organizations manage trial-related data and documents via paper files through monitors located in various research centers, mailing them to the data statistics department for data aggregation, statistics, and analysis. Traditional clinical trial management methods have many shortcomings, including a lack of timeliness in project management, a lack of standardization in the research process, difficulties in data and document management, high manpower costs for document writing, and hindering supervision by project directors and sponsors.
Before the advent of clinical trial management systems, drug/medical device development organizations managed clinical trial-related data using paper or electronic documents, aggregating data through mail or email. While electronic documents represent an improvement over paper documents, several shortcomings remain:
● Management of project documents remains challenging;
● Most data still requires manual organization, statistics, and analysis;
● Standardization of the research process remains at the SOP stage;
● Lack of intuitive display of project status.
The Clinical Trial Management System (CTMS) under ClincalCloud enables efficient and standardized management of clinical trial data, ensuring the accuracy, reliability, and integrity of trial data, and providing strong technical support for the continuous, stable, and comprehensive development of enterprise clinical trial project planning, management, and implementation. By utilizing advanced internet technology, it provides research project management, research plan tracking, and research content interaction services to CRO branches and offices nationwide. It achieves standardized management of clinical research, simplifies research processes, enables researchers to implement better standard operating procedures, improves research quality and level, ensures accurate, reliable, and scientifically credible trial results, thereby effectively shortening the new drug development cycle and accelerating drug registration. This is reflected in the following aspects:
● Real-time management of clinical trial projects;
● Improved CRO project supervision capabilities;
● Ensuring standardized clinical trial processes;
● Automated statistical analysis of trial data;
● Facilitated management of trial data and project documents.
The Clinical Trial Management System (CTMS) under ClincalCloud strictly complies with ICH GCP guidelines and meets the requirements of the National Medical Products Administration (NMPA)'s "Good Clinical Practice (GCP) Guidelines for Drug Clinical Trials" in China.
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CPhI World Pharma Ingredients China
2020-08-21
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