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The healthcare sector is shifting towards digitalization in clinical trials because it helps to reduce the complexity of the trials and time consumed by the process.
FREMONT, CA: Clinical trials are one of the most complicated and time-consuming processes in the healthcare and life science industries. Even though the intricacy of clinical trials has increased dramatically over the previous decade, the number of trials has also increased. There have been many advancements in this field, and one of the driving forces that have made it easier for sponsors to deal with the complexities involved with the process is the digitization of clinical trials.
Here is an outline of the critical path of a clinical trials and digital transformation, which has made its complexity bearable and helped better understand the complexity involved in the trials. It describes the minimum number of steps and activities necessary to safely bring drugs and medical devices to market.
A well-planned clinical trial helps to avoid any potential delays. Based on the trial's design, the complexity of planning can increase. Understanding and anticipating problems that arise during the critical path of a clinical trial is crucial to completing the study on time and within budget.
Clinical Trial Study Protocol
The clinical trial study protocol is a framework that defines and manages the trial. A group of experts puts it together. All study investigators are supposed to follow the protocol to the fullest. The protocol explains the proposed trials' scientific rationale, goals, design, technique, statistical considerations, and organization of the planned trials.
Case Report Form
A case report form (CRF) is a paper or electronic survey used in clinical trial research.The sponsor of the clinical trial uses the case report method to gather data from every participant patient. CRF stores or documents all data on each patient enrolled in a clinical study, including adverse events.
An institutional review board (IRB) is a sort of body that oversees research ethics by examining research techniques to ensure they are ethical. Such committees are formally charged with approving (or rejecting), monitoring, and reviewing human biological and behavioral research. To assess whether research should be done, they frequently conduct some risk-benefit analysis.
The recruitment of the study investigator is one of the most critical factors in the clinical trial's effectiveness. A timely selection of investigators aids in site onboarding, allowing patient recruitment to begin as soon as the IRB is approved.
Once the IRB has approved the sites, they can immediately begin recruiting suitable patients. The first patient first visit (FPFV) is a critical milestone for the sponsors because it lays the groundwork for future tasks that must be completed for the study to be completed on schedule.
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