A software system which the pharmaceutical and biotechnology industries use to supervise and handle clinical trials in clinical research.This software systems manage and maintain functions like achieving and reporting, planning, tracking milestones and deadlines. The purpose of a Clinical Trial Management System is that it generally acts as a digital dashboard for trial managers by providing data to a business intelligence system.
Background
While specific solutions have assisted to unify special areas of applications, serious inefficiencies were brought about by sustaining several systems that contained overlapping data. The industry actualized that the data reconciliation activities had been reduced by eliminating data divergence or error and also helped to ensure accurate up-to-date information always by those who are accountable for a clinical trial. The issues of data redundancy and duplication of data has increased, as the number ofsignificant application growing with greater implementation of Electronic Data Capture and other technologies. As a result, productivity is improved by this new ‘e-clinical’ approach and reduces the need of internal staff is decreased to input data.
Functions
In-house or home-grown programs are used to handle the data in the initial stages of clinical trials when the amount of patients and tests are small. The volume of the data and its complexity grow in the later phases which prompts several establishments to endorse more comprehensive software. Regulatory compliance, budgeting, financials, investigator management, compliance with government regulation project management, patient management and compatibility along with more systems like adverse event reporting system and electronic data capture are included in the software that is available.
Clinical trial management systems are commonly used where clinical research takes place such as cancer centers, physician practices, academic medical centers and research hospitals in addition to biotechnology and pharmaceutical industries to provision day-to-day actions like improving clinical data management by equipping staff, rendering a core place to store all information related to the trial, conducting study feasibility, along with biostatisticians and database administrator and streaming the workflow to the trial coordinators and investigators, the sites may operate CTMS sponsored by pharmaceutical companies that participate in their trials. Some CTMS require dedicated servers, while some Clinical Trial Management System are cloud based and are given outas a service in a software.
Commercial products
Considerable vendors on a commercial basis are available. One example is a full-featured SaaS system that is the Danish(European) company. Intrinsic is the world’s first Clinical Trial Management system built on Microsoft dynamics, with integration to Microsoft office including Excel, Outlook and SharePoint and EDETEK CTMS provides one of the first cloud based Clinical Trial Management system solutions.