Build Flexible Clinical Trial Design — And How Software Can Help


Traditional clinical trials have a basic format that can at times be inflexible. Therefore, a clinical research organization needs to design Veristat trials and analyze them in a prescribed plan. However, with the increase of randomized trials, there is a need to have a flexible method to perform the treatments. With the breakout of epidemics and rare diseases, there is a need to hasten the clinical trials’ pace to provide the necessary treatment to the patients. Hence flexibility and adaptive features are essential for all the trial designs and testing of new treatments.

To achieve maximum additivity and maximize the use of the master protocols, there is a need for collaboration between the pharma companies, requiring more time and resources. Still, it can be easily solved by integrating tech in their research. Clinical Research Organizations are now using Clinical Trial Management Systems (CTMS) to help build more flexible trials. The CTMS help streamline the studies from start to end. They handle the CTF design, protocol management, data collection, and analysis. The systems also report for compliance for the clinical research data to the regulatory authorities. There are different types of clinical trials software, and they all perform other functions. They include:

EDC (Electronic Data Capture System)

The EDC system allows users to gather patient data during clinical studies easily. These systems also have a user interface that allows patients to input their data in electronic forms. EDC systems use validation to ensure that the documents are filled correctly. They also have a reporting tool that allows the users to evaluate the data they have acquired. ECS systems have been in use since the 1990s, and they are constantly evolving with improvements in technology. With the modern EDC systems, you can target desired patient characteristics or a research stage. The modern systems have cloud data storage, clinical data analytics, role-based permission, interactive dashboard, and electronic health record integration.

CTMS (Clinical Trial Management System)

A clinical trial management system is a cloud-based software used to manage studies from start to finish. They are used in trial planning, tracking the study, and analyzing the clinical studies. The systems help businesses to improve their clinical goods while reducing the time it takes them to bring the product to the market. CTMS are also used to ensure compliance with the industry laws and standards. They are also used to manage and locate patients who want to participate in the clinical study. They also track their participation and handle the funds. CTMS are often used alongside other software that specializes in a specific area. They are frequently used alongside integrated trial study automation software and EDCs.

Integrated clinical study automaton software

The integrated clinical study automation software is also a cloud-based program that only focuses on a specific trial area. Examples of such systems include data storage, CRF designers, Standards governance, Metadata management, submission to regulatory agencies, and statistical computations.

Technology has changed in almost every industry, and the clinical world is not left behind. However, pharmaceutical companies need to adopt the study trial technology to help make the entire process run smoothly and get effective medicines to the market fast.