eClinical Solutions: The Accurate and Automated Method to Minimize Clinical Errors
eClinical solutions refer to a combination of applications, services, and technology, all working together to automate data collection as well as management of clinical trials with the aim of replacing paper-driven and manual methods.
These solutions are finding widespread use in the healthcare industry by the professionals as they provide a host of benefits. These include centralized end-to-end management of clinical trial activities, real-time status tracking, elimination of reliance on manual processes, and maintenance of multiple databases, which improve the overall efficiency of clinical trials.
Types of eClinical Solutions
Clinical Data Management System
Clinical data management system can be described as a tool that is an important aspect of clinical research. It helps in managing the data of a clinical trial which starts with the clinical trial data being collected at the investigator site. To bring down the chances of errors owing to human entry, the systems make use of different means to ascertain data. Clinical data management systems can be part of the functionality of a clinical trial management system (CTMS) or can be self-contained. CTMS that has clinical data management functionality can help in validating clinical data and aid the site in using various other critical activities such as building patient registries as well as in patient recruitment efforts.
Randomization and Trial Supply Management
RTSM system accurately and efficiently automates supply and resupply to depots and sites, control patient randomization, and also handles drug dispensation, which is the most aspect. It can be set up fast and modified instantaneously when required. This helps bring down the number of trials by weeks, thereby saving money and delivering therapies to market in a shorter time.
RTSM is an essential tool with respect to clinical study management. Randomization in clinical trials helps the treatment group not only balance but also get rid of selection bias. Clinical trial supply management ensures delivery of the accurate investigational drug or supplies to the appropriate subject at the given time.
Electronic Clinical Outcome Assessment
Electronic clinical outcome assessment (eCOA) refers to a method of attaining data electronically during clinical trials. It helps substantially enhance the quality of study data, and at the same time meeting with the regulatory requirements. A surging majority of clinical trial stakeholders such as CROs, regulators, and sponsors view eCOA as a highly effective method to attain high-quality and more reliable data instead of using traditional and paper-based methods.
eCOA helps Eliminate Transcription Errors
As paper diary studies involve manual transcription of data into the trial management system, there is a high chance of errors as well as other inconsistencies. With eCoa, these steps are automated which leads to lowered down number of transcription errors. Any discrepancies, missing data along with other data quality problems can be detected in real-time.
eCOA Elevates Patient Protocol Compliance
Patients that make use of electronic patient-reported outcome (ePRO) display considerably higher protocol compliance. With the use of electronic alerts or reminders, context-sensitive messaging, animated compliance feedback and dynamic, ePRO helps attain data in real-time. This helps deliver accurate and reliable information during a clinical trial.
Electronic Trial Master Files
An electronic trial master file (eTMF) can be described as a trial master file in electronic format containing digital content. It refers to a kind of content management system used in the pharmaceutical industry, offering a formalized way of organizing and storing images, documents, along with other digital content for pharmaceutical clinical trials.
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