Medical clinical research and development information processing system and method thereof

Abstract

The invention discloses a medical clinical research and development information processing system and a method thereof. The system includes a research and development main-body end, which has a firstcommunication module, a first information receiving, classification and storage module, a first information invocation, analysis and processing module and a report generation module; and a subject-specific terminal, which is held by each medical clinical trial subject or medical user, is used for collecting, inputting, storing and transmitting various types of clinical trial information of the subject, and realizes information exchange with the first communication module of the research and development main-body end through an internet. The system can significantly expand sources and types ofinformation related to medical clinical research and development, improve timeliness, systematicness and integrity of information collection, greatly expand depth and breadth of research and development, and thus significantly improve efficiency of pharmaceutical research and development.

Description

technical field [0001] The invention relates to the technical field of medical research and development information processing, in particular to a medical clinical research and development information processing system and a method thereof. Background technique [0002] State Food and Drug Administration Decree No. 3 "Quality Management Standards for Clinical Trials of Drugs", State Food and Drug Administration and National Health and Family Planning Commission Order No. 25 "Quality Management Standards for Clinical Trials of Medical Devices" and other pharmaceutical clinical trial management regulations and relevant international regulations In the literature, the clinical trial methods and procedures of various medicines are standardized. At present, the clinical trial information used in the research and development methods of various pharmaceutical clinical trials including drugs, medical devices and consumables, and various diagnostic and treatment technologies in the w...

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Problems solved by technology

Although this method can effectively guarantee the professionalism, accuracy and reliability of clinical trial data, because the trial data information mainly comes from the researcher's outpatient follow-up subjects and their corresponding examinations, and the outpatient follow-up is subject to the test results. Therefore, there are many problems and limitations in conventional medical clinical trial methods: First, the interval between outpatient follow-up visits is often long, especially Firstly, when subjects undergo medical clinical trials, their clinical response information, which is crucial to clinical research, often cannot be recorded in a timely, complete and effective manner; Restricted by factors such as accessibility, there are often significant deviations between the time of outpatient follow-up and examination and testing of subjects and the best follow-up or examination time after receiving medical clinical trials, and the relevant clinical response information of outpatient follow-up or examination often appears distorted The third problem is that factors such as the accessibility of inspection and testing facilities are often considered in the design of clinical trial protocols, and the inspection and testing items for outpatient follow-up are limited, which is not conducive to more comprehensive, systematic, and dynamic collection and recording of subjects. All kinds of clinical response information; Fourth, the research and development of traditional Chinese medicine and other traditional medicines face greater difficulties because the symptoms of clinical responses of subjects and non-biochemical examination indicators are difficult to carry out timely and effective inspection and detection by modern medical means

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