In December of 2014, Sandra Freeman, writing for Applied Clinical Trials, predicted that 2015 would prove to be the year of eClinical, with a reduction in paper usage and a rise in eSignatures resulting in faster study start-up time1. According to Globe Newswire, by 2020, eClinical will be a nearly $6 billion-industry2. All this points to what is, for many, already obvious: in the arena of clinical trials, paper is becoming a thing of the past, with EDC rapidly becoming ingrained as the new standard for study build, data management, and more.
This paradigm shift is hardly a surprise. For starters, there’s little reason to resist a departure from something as cumbersome and messy as paper-based data management; this is true of many industries. But Pharma has its own reasons to be excited for this shift. In the wake of outbreaks and epidemics that have struck various corners of the globe in recent years, there is more pressure than ever to shorten the timeline on development of vaccines and treatments1. The efficiency proffered by eClinical makes it possible to achieve this goal without compromising the thoroughness of a study.
Two Concurrent Trends
This rapid increase in the adoption of eClinical coincides with an expansion in the number of Phase I studies being initiated around the world. Recent years have seen a surge in registration of new clinical trials, most of all in South Asia and East Asia, and that surge has shown a trend: the number of Phase III studies has shrunk while early phase trials are on the rise. And of all the early phases, the number of Phase I studies has gone up the most, with a soaring increase of 82% between 2006 and 2012, dwarfing the 21% uptick seen in Phase II3.
The intersection of increases in eClinical adoption and Phase I study registration speaks volumes to the utility of SaaS companies like Medrio in today’s clinical research industry. With a specialization driven by a flagship product specifically tailored to Phase I, Medrio is uniquely prepared to take advantage of the new market for early-phase trials. It is this intimate focus that makes Medrio a strong industry contender.
In addition to this niche advantage, Medrio is also shielded from some of the obstacles that stand in the way of universal adoption of eClinical technology. eClinical can be expensive, and the cost of implementation is frequently prohibitive. And as the skill set of research professionals principally resides, of course, in clinical research, personnel frequently lack the technological skills that are often a prerequisite for utilizing eClinical technology1. Medrio, however, is competitively priced and requires no programming expertise to operate, and is therefore capable of effectively mitigating these challenges.
As the use of eClinical and the registration of Phase I studies rise concurrently, the EDC companies best poised to benefit from this trend are those whose hallmarks include Phase I services and the ability to provide the technological legwork for their customers. It would be wise for forecasters like Sandra Freeman to consider this in next year’s predictions.
1 Freeman, Sandra; Predictions for 2015: Trends in Clinical Trial Processes; Applied Clinical Trials; 12/15/2014
2 eClinical Solutions Market 2016 – Global Forecast to 2020 – Product, Delivery Mode, Clinical Trial Phases, End User Analysis of the $5.9 Billion Market; Globe Newswire; 2/11/2016
3 Novak, Thomas; Payeur, Ginny; Belotserkovsky, Maxim; Decline of Clinical Trials in Central and Eastern Europe: Fluctuation or Trend?; Applied Clinical Trials; 6/16/2014