It comes as no surprise to see the prefix e that stands for electronic in this age of flourishing technology, and eClinical is no exception. With the help of constant technical advances, eClinical is playing a crucial role in the evolution of modern clinical trials.
Not just technology
In its infancy, eClinical was used as a broad term for any technology applications used in the clinical trial process. These include electronic data capture (EDC) or clinical data management system (CDMS), electronic case report form (eCRF), electronic patient-reported outcome (ePRO), interactive voice response (IVR) system – also called randomization and trial supply management (RTSM) system, and clinical trial management system (CTMS). However, recently eClinical has represented a business process that attracts a lot of public attention and investment as well.
Agencies such as contract research organizations (CROs) have emerged in response to the growing outsourcing demand of pharmaceutical companies while conducting studies. Meanwhile, mergers and acquisitions of such organizations have witnessed a boost of activities in recent years with billion-dollar contracts. eClinical is undeniably the trend of clinical trials in years to come. The question then remains what benefits modern clinical trial process gain from eClinical.
Say goodbye to paper and spreadsheet
It goes without saying that eCRF and EDC spare us the burden of paperwork. Back in the days, patient data was recorded on paper before being re-entered onto a spreadsheet. The high possibility of errors in this process required double data entry, and later multiple verification steps before the data were finalized and locked.
However, with the help of technology, we are now able to directly key in information onto eCRFs which will automatically generate a database in the regulated format. Such database will then be transferred to an interface within EDC that allows easy tracking of subjects and source data verification (SDV). Furthermore, discrepancy management is no longer manually conducted. Data Managers only need to set up edit checks and the system will know when something fuzzy comes up.
Less time, less money
With this in mind, eClinical increases trial efficiency by greatly reducing study duration as well as costs. Remote collaboration among people involved in the procedure enabled by cloud-based EDC means immediate actions can be done once requested. As a result, an enormous amount of time between data generation, data verification, and data lock is saved, while costs for such clunky steps are much curtailed.
Flexible means adaptive
eClinical practices are doing a better job than traditional approaches in answer to increasingly complex protocols and strict regulations. In other words, the flexibility and adaptability of this technology-based method allow it to quickly evolve to match with newly introduced standards, which the cumbersome system of the old days fails or hardly manages to do. At the same time, an online work platform allows for easy collaboration on a multi-nation scale – a merely impossible task for traditional methods. Technologies were invented to better serve human activity, and eClinical is no doubt a solid representative.
Along with the advance in healthcare to cater for the growing demand of new medicines and therapies as well as the expansion in the number of clinical trials conducted every year, eClinical is expected to flourish in a foreseeable future. Thus, it is our job to catch up with the trend if we are to blend into this promising and booming industry.