7 Critical Software Tools for Clinical Trials 

With the increasing complexity of clinical trials, organizations must rely on a portfolio of software products that enable them to access, analyze, and report data across projects and clinical sites. With the right system of tools in place, FDA approval is streamlined with increased efficiency in all phases of the trial.  

Here are 7 software components of a successful clinical trial process that all stakeholders should be aware of:  

  1. Clinical Trial Management System (CTMS): Managing all operational aspects of a clinical trial from study startup to closeout, a CTMS centralizes information related to protocols, subjects, staff, financials and billing, etc. They ensure accurate, up-to-date information and enhance collaboration, efficiency, and oversight.  

  1. Electronic Data Capture (EDC): You can reduce errors and improve accuracy of patient data entry by collecting and managing it electronically through an EDC, which may integrate with mobile devices or patient wearables. 

  1. Electronic Trial Master File (eTMF): An eTMF leverages software and server technology to assist the setup, collection, storage, and tracking of essential clinical study documents, ensuring regulatory compliance as well as efficient access for stakeholders. 

  1. Clinical Data Repository (CDR):  Aggregating patient-centric health data from multiple sources, the CDR is organized and optimized to provide a unified view that enables researchers to improve patient care and the research itself. 

  1.  Electronic Submission Processing: Health Authorities worldwide require that all clinical trial documentation and regulatory and marketing applications be submitted electronically. This improves the efficiency of delivery, formatting, and review of the files, documentation, and applications submitted. Each agency provides a gateway for this purpose (e.g., FDA’s eSubmitter.) 

  1. Statistical Computing Environment (SCE): An SCE provides a space for modeling and computational work using aggregated clinical trial data and multiple programming languages (MATLAB, Python, R, etc.)  It supports the development of analysis datasets, tabulation datasets, table listings, graphs and submission components for all clinical trial-related deliverables. 

  1. Quality Management System (QMS): Throughout the clinical trial, it is imperative to ensure that customer and regulatory requirements are met. The QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives and helps coordinate and direct the organization's quality activities.  

If you are part of the clinical trial process, you should recognize and understand the role each of these software tools plays in the completion of a successful trial and drug submission. They make it possible for you to access all the information you need to make well-informed decisions and see your trial through to a successful conclusion.