NeuAge Institute (NAI)

The Benefits of Using Clinical Data Management Systems (CDMS) After Clinical Research Training

Whether you are a recent college graduate or already working in the pharmaceutical industry and looking to upgrade your skills, the NeuAge Institute’s modern, comprehensive, and completely virtual Clinical Research program will prepare you for success in your new career. With the option to go at your own pace while receiving support from industry experts, in addition to networking and career placement opportunities, our students can confidently enter the workforce once they graduate. 

As a Clinical Research Associate, your main responsibilities will include coordinating clinical trials and ensuring quality assurance of the projects you are working on. A significant skill you will obtain through your studies is the ability to confidently and accurately store the various data collected through the phases of a trial. Historically, data has been recorded on paper and then entered and saved into a data management system as an Electronic Case Report Form (eCRF). More recently, trials are turning to Electronic Data Capture (EDC) systems and replacing outdated paper records with electronic ones. 

Keep reading to learn about the benefits of implementing Electronic Data Capture (EDC) systems after your Clinical Research Training.

The authorization of new drugs is based upon the trust that clinical trials will intend to find the answers to the investigation problems by providing clinical data which further proves or disapproves a particular hypothesis. The type and quality of the clinical data play an imperative task in the conclusion of the study performed. Therefore, this clinical data is appropriately managed to obtain accurate results for the clinical study; thus, a Clinical Data Management System (CDMS) is needed for the authentication of the study. CDM is implied in all the facets of operating computers, the dispensation of the clinical data, managing the subject data and database systems to support the collection of the data. CDMS is precisely defined as the collection, integration and validation of the trial data (Fig 1). 

Fig. 1 Elements of Clinical Data Management

Therefore, the organizations ensure that the clinical trials performed and the data obtained are in the hands of well-qualified and trained staff. Thus, the key objective of CDMS is to offer high-quality data by observing the errors and missing data and keeping it as low as possible to congregate maximum data for analysis. Various practices have been developed to ensure that the data obtained is complete, processed correctly and reliable. This has been easily achieved by the use of applications of the software that present effortless detection and motion of data discrepancies and is used to maintain audit trials. In clinical data management, software is generally required to address the Electronic Data Capture (EDC), preparation of the electronic FDA submission, and acceleration of the clinical trial management processes.

Using an EDC After Your Clinical Research Program Will Increase the Quality of your Trials

One of our clinical research courses, Clinical Data Management and Data Integrity, introduces data management with a focus on Electronic Data Capture systems. EDC systems have innovative tools that ensure that the clinical trial that is conducted maintains high-quality data that is extremely accurate. Auto checks can identify incorrect data and identify mistakes in real-time. Numerical Data Validation allows an EDC to automatically detect and suggest changes to the information that may have been entered incorrectly. Remote Monitoring allows access rights for you as a Clinical Research Associate to observe a wide range of data and filter through the vast amount of information in a single click. While Medical Coding gives all diseases and symptoms their own unique code in accordance with internationally accepted terminology to avoid inaccuracy. These are just some examples of the many tools that are included in many EDC systems to ensure high-quality data by improving efficiency and access while minimizing errors. 

 

NeuAge Institute’s clinical research courses will educate you on clinical data management using EDCs.

EDC Systems Can Shorten the Duration of Clinical Trials

The global pandemic is the perfect example of the importance of having efficient trials that can produce results quickly. During your clinical research program, you will learn how EDC systems can save a substantial amount of time throughout the entire trial process. With the ability to integrate data from various sources, instantaneous access to this data, as well as a quicker query management process, clinical trial teams can make well-informed decisions in a shorter amount of time. Towards the end of the data collection stage of a trial, EDC systems also expedite the refinement and statistical processing involved, which also can vastly shorten the duration of the study.

 

EDC systems allow data to be integrated from various sources in real-time.

EDC Systems Lower the Costs of Clinical Trials

One of the greatest benefits of using an EDC system is its cost-effectiveness. As mentioned, EDCs can significantly shorten the duration of a trial, which in itself will save a large sum of money. In addition, most research work and clinical trials are under tight budgets, and each penny must be accounted for and fall within monetary limits. Using an EDC system allows you to automate many of the procedures of a trial rather than budgeting for human resources. This is especially beneficial in situations where multiple countries and sites are involved in a trial, as on-site monitoring can quickly become extremely expensive. As a Clinical Research Associate, implementing an EDC system will allow you to remotely monitor the data and report any problems to an investigator.

 

Are you interested in clinical research training?

Contact the NeuAge Institute for more information today!

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