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The electronic case report form (eCRF) is a vital application throughout the development of clinical research. It collects and manages all clinical and laboratory data for subsequent analysis and conclusions. There are no regulations requiring an electronic case report form (CRF). However, eCRFs offer several advantages over manual CRFs. Collecting data through an eCRF on a computer makes all the information available in real-time, ensuring the accuracy of the data, accessibility from different locations, faster safety alert decision-making, improving management efficiency, and reducing costs.

The IWRS (Interactive Web Response System) is a web-based interactive Voice Response System used to control clinical trial telematic processes, such as stock management or patient randomization, facilitating multicenter and international clinical trial management.

The CTMS is the Clinical Trial Management System. It is the essential kit of tools necessary to plan, manage and conduct an effective follow-up of clinical trials. It is a comprehensive and specialized project management application accompanying the study team through the trial start, enrollment, and follow-up, until its closure.

Remote monitoring (RM) means that monitors do not visit the site to transfer and review the data. Data monitoring is conducted virtually. With digital technology, contract research organizations (CROs) and study sponsors can access the data wherever they are.

The eTMF (Electronic Trial Master File) is an application that uses server-based software and technology to help with the setup, collection, storage, tracking, and archiving of essential clinical trial (CT) documents that comprise the trial master file (TMF).

The CROs (Clinical Research Organizations, also known as Contract Research Organizations are essential collaborators for the smooth running of a clinical trial CT.

The end of a clinical trial (CT), unless terminated early, matches with the last visit of the last participant or upon completion of any follow-up and data collection process, as described in the protocol.

A clinical trial finishes when the last patient enrolled completes all their visits and follow-ups. However, a clinical trial may be terminated early for different reasons.

What is the role and purpose of statistics in clinical trials? We tell you

There is no established time for testing and approving a drug, but in general, completing the first 3 phases of clinical trials can take 10-15 years or longer before starting the approval stage.

A clinical trial may target different participant profiles, depending on its Phase.

Observational studies are those in which the researchers only observe events without intervening or altering the standard clinical practice.