What is a CTMS (Clinical Trial Management System)?

A Clinical Trial Management System (CTMS) is a software system use by the biotechnology and pharmaceutical industries to manage clinical trials (Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials) in clinical research. The system maintains and manages planning, execution, and reporting functions, along with participant contact information, deadline tracking, and milestones.

Terminology

CTMS is a term use within the bio-pharmaceutical industry to refer to assay automation technology. Originally “Clinical Trial Management System (CTMS)” was use to refer to whatever technology was involve.

Without a more specific definition, the industry use “Clinical Trial Management System (CTMS)” to name technologies such as electronic data capture, clinical trial management systems, or randomization and trial supply management systems, typically using interactive voice response systems, electronic diaries of patients and other applications.

More recently, the term has evolve to encompass the entire ” business process ” rather than individual technologies. An example of an “Clinical Trial Management System (CTMS)” is the combination of EDC and IVR systems where common data is share in a way that eliminates the need for users to enter the same data or perform the same action in both applications. The change in the definition of “Clinical Trial Management System (CTMS)” has been a natural part of the industry’s evolution to seek better ways to use multiple technologies together within a clinical trial.

Background

While individual solutions have help automate or optimize particular application areas, maintaining multiple systems containing overlapping data and functions has created significant inefficiencies. The industry find that eliminating data discrepancies between systems has reduce data reconciliation activities and help ensure that those responsible for a clinical trial always have accurate and up-to-date information.

As the number of relevant applications increases with greater adoption of EDC and other technologies, data duplication and redundancy issues in the process they have increase. As a consequence, the search for an integrated technology suite to streamline workflows and improve usability has become a key feature of the industry’s latest “Clinical Trial Management System (CTMS)” approach. Plus, it improves productivity by reducing the need for internal staff to enter data.

Read more: What is a CRO?

Purpose

Often a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial administrators. Clinical Trials Management System (CTMS) allow experts to easily access centralize data and thus reduce the number of delayed trials (Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials).

Sponsors can work with a database of previously screened contacts and names of volunteers who are eligible to participate in a given trial. Clinical trial management systems are cost effective and profitable as they can also be use to collect and organize information that can be share with different care providers and distribute through different systems. These systems can facilitate site identification and recruitment and can provide control and tracking over the enrollment and database of subjects.

Features and settings

In the early phases of clinical trials (Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials), when the number of patients and tests is small, an in-house or proprietary program is often use to handle your data. In later phases, data volumes and complexity increase, motivating many organizations to adopt more comprehensive software.

Available software includes budgeting, patient management, government regulatory compliance, project management, finance, patient management and contracting, investigator management, regulatory compliance, and compatibility with other systems such as electronic data capture and reporting systems.

Reporting of adverse events.

In addition to the pharmaceutical and biotech industries, Clinical Trials Management System (CTMS) are widely use in sites where clinical research is conduct, such as research hospitals, physician offices, academic medical centers, and cancer centers.

While pharmaceutical companies sponsoring clinical trials (Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials) may provide a Clinical Trials Management System (CTMS) to sites participating in their trials (Oncology Clinical Trials, Ophthalmology Clinical Trials, Gastroenterology Clinical Trials).

Sites may operate a Clinical Trials Management System (CTMS) to support day-to-day operations in areas such as conducting feasibility studies, streamlining the workflow of trial coordinators and investigators. Clinical Trials Management System is providing a centralize place to house all trial-related information and improving clinical data management by equipping staff including bio-statisticians and database administrators.

Some Clinical Trials Management System (CTMS) are cloud-base and deliver on a software-as-a-service (SaaS) basis, while others require dedicate servers.