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How Software Streamlines The Clinical Trial Process

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How Software Streamlines The Clinical Trial Process

The advancement of technology paves the way for software development, now used in clinical trials worldwide. Examples of software programs in clinical studies include validation tools and clinical metadata management software. They have helpful features and capabilities for contract research organizations (CROs) and research teams to accomplish their ultimate goal: obtain regulatory authority approval for a new drug or treatment.

This article will explain how a software program streamlines the clinical trial process and the appropriate solutions to build faster, more secure, and more accurate studies. Continue reading to learn more.

Saves Time To Expedite Clinical Studies

The clinical trial process involves three main phases. Phase 1 is the earliest, with 20 to 100 participants, and phase 3 is the latter clinical trial with 300 to 3,000 participants. In some trials, phase 0 is the earliest stage and phase 4 is the latest after a drug licensing or Food and Drug Administration (FDA) post-approval.

Clinical trials can take six to seven years to complete. Phase 1 involves assessing the dosage and safety of a drug or treatment that lasts for several months. On the other hand, phase 2 trials inspect the efficacy and untoward effects of a drug or treatment, lasting up to two years.

The duration of each trial depends on many contributory factors, such as the software technology used in data gathering, accessing, processing, and storage.

Software shaves off months from traditional clinical trials that involve manual tasks, such as manual data entry of participants’ personal data. With electronic or digitalization of metadata, there’s no need to manually enter the same information per patient visit, saving so much time.

Eliminates Manual Work With Visual Automation

As mentioned, software programs can help CROs save time by reducing or eliminating manual work. The technology behind this capability is automation.

Study Data Tabulation Model (SDTM) is a standard structure for clinical trials, which is a part of a product’s FDA application. Each CRO must comply with the proper format or template of a clinical study before submission to ensure approval. Otherwise, there’ll be a significant delay in launching a new drug or therapy.

A software program can help eliminate manual work associated with creating SDTM define.xml files necessary for FDA submission after a clinical study.

Creating an SDTM define.xml format for a clinical trial is much easier with visual automation software, such as Formedix data tools. For instance, a validation tool can help CROs check datasets and detect formatting deviations for strict compliance purposes.

Centralizes Data Access With Clinical Metadata Repository

One of the bottlenecks of traditional clinical studies is appropriately organizing and managing data, especially for clinical studies in multiple sites involving a large number of participants. Even individual clinical research projects face similar data management issues. Software development of clinical metadata repository resolves this problem.

Clinical metadata management software allows CROs to build studies faster. CROs can reuse and standardize clinical studies using a fully integrated and secure clinical metadata repository. Creating and managing change requests and measuring their impacts are possible using this tool.

CROs can handle all electronic case report forms and deliverables using one software program. Therefore, all clinical trial content, such as mappings, forms, datasets, and guidelines, is available in a centralized, single place.

Moreover, teams can easily collaborate because it’s easy to integrate a clinical metadata repository with other systems, saving time, effort, and resources. Hence, clinical research teams can share and deliberate relevant information about the study.

Promotes Clinical Trial Data Security

Cybersecurity risk assessment is a must for all businesses, including clinical studies. Any minute, a data leak can jeopardize a clinical trial initiative, causing doubts from patients and healthcare providers and divulging drug formulations to competitors.

Cybercriminals use sophisticated digital mechanisms to steal patient information and clinical study findings from healthcare organizations and agencies. In a clinical trial environment powered by cloud technology, CROs can depend on professional-grade cybersecurity features with rigorous and intuitive data access controls to streamline the process.

Keeping all clinical trial documents and changes in one place can avoid any possible confusion and unknown threats from unintentional data leaks. In addition, centralized cloud management saves time for multiple-site and large random clinical studies and other complex logistics matters.


Dedicated software programs help streamline the clinical trial process in many different ways. The power of automation, data analytics, artificial intelligence, cloud computing, machine learning, and other software technologies can help build more studies in less time. This way, more patients can benefit from newly discovered, proven-effective treatments.

Roy Haines is a software development specialist with over 10 years of experience. He conducts seminars and writes blogs to give businesses insights into computer applications. In his free time, Roy enjoys playing video games and traveling.


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