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Showing posts from December, 2019

Software’s used for the Clinical Data Management

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Pharmaceutical and biotechnology sectors are at the forefront of the technology use since their infancy. These companies are constantly in the requirement for innovative tools that are cost-effective, easy-to-use, intuitive, and compliant to regulatory requirements. Moreover, these technologies have been making strides in the industry, where use of the software makes the time consuming tasks much quicker and easier. Clinical data management forms an important part of the clinical trial process. It helps in assisting clinical research professionals in managing, collecting, and collating the study data of all the reports. They also help in assisting the sites in gathering the trial specific information, track study performance, planning, scheduling and well-informed decision making. Scalability and flexibility software is the requirement of the industry for performing clinical trial operations, therefore enabling the organizations to manage and collaborate with its units or within the

Good Clinical Practice (GCP) guidelines for clinical trials

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Good Clinical Practice (GCP) is an international scientific quality standard for the design, performance, conduct, auditing, monitoring, recording, and reporting of clinical trials. GCP is a document that helps regulate clinical trials and is published by the international council of Harmonization (ICH). ICH-GCP guidelines are used in clinical trials across the globe with the primary aim of protecting and preserving human rights. Moreover, it also serves to protect the rights, confidentiality, and integrity of trial subjects. The primary goal of  clinical research  is to find the new well-defined standards of therapy, limited population to benefit the larger population. Clinical trials are the mechanism to prove new therapies are safe and effective. By following GCP guidelines, the accurate, verifiable, and reproducible data can be generated from the clinical trials, all of which are necessary to advance scientific knowledge. Conducting research according the GCP guidelines is also t