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Pre-Clinical & Clinical Trials

Health Industry Insights believes that an evolution in the use of technology for clinical trial management is underway. This change is building on the growing imperative to measure and communicate results electronically and in real time. The coming months will see significant change in the capabilities of clinical research organizations (CROs) as they invest in updating their infrastructures and in leveraging innovative technologies for clinical trials. These investments are coming now for a variety of reasons including increased competition to offer cost savings and enabling better communication via use of collaborative technologies, CTMS, and clinical trial supply management solutions.

HCL Clinical Development Offerings

Clinical Trials

Clinical trial management is a widely used term in the clinical trial industry; however, agreeing upon the meaning can be very difficult. To some, clinical trial management refers to a software system or tool utilized to track research deliverables, timelines and conduct scheduling, but this definition is extremely narrow and does not embrace the human factors in clinical research. As a result, for most clinical managers, clinical trial management refers to a standards-driven process that is initiated by a project manager and followed to successfully manage clinical trial sites, clinical research associates (CRAs) and workflow. This process certainly includes clinical trial management tools or software, but also requires attention to detail, creativity, perseverance and no small amount of diplomacy. It explores the process of clinical trial management, incorporating project planning as a tool to define and clarify expectations, and focuses on the key characteristics one looks for in a clinical trial manager.

Clinical Data Management
  • Clinical Data Management is the technology and processes that manage clinical data to produce a high quality, clean and analyzable database

  • Clinical Data Management is a key business process in drug discovery lifecycle and the DM structure ensures drastic reduction in time from development to market for all phases of clinical research

  • Clinical data management is the process of collecting, entering, cleaning, and reporting on data recorded in clinical trials

  • Data management is involved in all aspects of processing clinical trial data, working with a range of computer applications and database systems to support collection, cleaning and management of subject or patient data

Data Analysis
  • Data Analysis is the process wherein the data collected during the process of trials and reviewed during the clinical data management is analyzed to decide upon the safety and efficacy parameters of the drug. Analysis is done by taking out several listing, tables and figures from the data with the help of any analyzing software.

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