With the implementation of the Affordable Care Act, the era of digital health has arrived in the United States along with many other countries. What if and how could this impact the approach of conducting clinical research with a change in the “source” of data. In a clinical study, source is the initial recording of data. If the original recording is from a digital media, it is referred to as eSource. The FDA eSource Guidance describes different ways to transmit eSource data to an electronic case report form (eCRF) system, has the time come for the transference of data from a patient EHR to an eClinical solution?
With the advancements in technology, software solutions and integrated data collection and automation, the definition of eClinical continues to evolve. Firms are facing the challenge with the gathering and synthesis of clinical trial management data in a single source and sometimes even being able to graphically presented solution. The market place of multiple vendors providing the different software solutions of clinical trial management software (CTMS), clinical data management systems (CDMS), electronic data collection (EDC), interactive voice-response systems (IVRS/IWRS), electronic patient reported outcomes (ePRO), randomization and trial supply management (RTSM) and electronic master file (eTMF), it has become problematic for sponsors to have a holistic view of their trial without going to different systems for the data. The challenge then becomes, once sponsors have the data, how do the convert this data into actionable information?
Clinical trials are conducted on multiple and disparate systems making the task of control and management challenging and heavily manpower intensive. Imagine the complexity investigation sites face using multiple systems from different sponsors to achieve the task of tracking trial progress!
The StrategyMedic Clinical Research Informatics (CRI) methodology, a subdomain of Health Informatics, focuses on developing and improving informatics tools and solutions to accelerate research, clinical trials, and medical centers and community practice. It involves the application of informatics towards the discovery and management of new information and awareness relating to health and disease. The StraegyMedic methodology employs innovative solutions for clinical and population-based research. The methodological framework is organized around workflows, data sources, and platforms.