e-Clinical Solutions – Leveraging Clinical Trial Data to Decrease Risk, Time, and Cost
eClinical solutions is used to improve the clinical development process through data management and data analysis. It offers total transparency and utilization of the clinical and operational data by providing data management software and customized data management services, including electronic data capture (EDC), clinical reporting, clinical data repository platform and data management and standardization. The advantages and applications of eClinical software allows users to analyze, manage, integrate, and standardize all their clinical and operational data with the help of integrated advanced visualization and analytical capabilities. Software such as clinical trial managements system (CTMS) help users to comply with government regulations, patient management, investigator management, budgeting, and adverse event reporting system among others.
The global eClinical solutions market was valued at US$ 3.5 billion in 2017 and is expected to witness a robust CAGR of 11.2% over the forecast period (2018 – 2026).
Figure 1. Global eClinical Solutions Market Value (US$ Mn), by Region, 2018
Increasing R&D by biotechnology and pharmaceutical companies is expected to drive growth of the eClinical solutions market
Increasing application of software solutions in clinical trials is the major factor driving growth of the eClinical solutions market. Increasing R&D activities by various biopharma and pharmaceutical companies and rising government funding to promote clinical research programs are expected to further boost growth of the market. Scientific and technological advances and increasing research on disease continues to fuel the development of new treatments for patients. According to U.S. National Library of Medicine, a steady increase in the number of new clinical trials are registered year-over-year, for the last two decades. Moreover, the time, costs, and complexities of R&D have increased over the recent past, introducing additional challenges to the process. Thus, various companies and research organizations are outsourcing a greater portion of R&D to independent services providers such as CROs, for specialized services designed to generate high-quality and timely data in support of regulatory approvals and support of post-approval regulatory requirements, in turn, lowering the overall cost. In 2011, Pfizer, partnered with Parexel and Icon. With this agreement, Parexel provided Pfizer with a range of clinical development services for five years.
Rising private and public funding to support clinical trials
Pharmaceutical companies and government funding agencies are increasingly funding various clinical trials. According to the Journal of the American Medical Association 2015, the number of clinical trials sponsored by companies were 6,550 and 1,048 by the NIH. In the U.K., the government funds health related research through organizations such as the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). They also help to coordinate cancer research nationally through the National Cancer Research Institute (NCRI). NCI funds around half of all cancer trials in the U.S. According to Research America, in the U.S., investment in health and medical R&D grew by 13.3% from 2013 to 2015. However, high implementation cost of software, lack of skilled professional, data privacy issues, and low awareness about the software are key factors hampering eClinical solutions market growth.
Key players operating in the eClinical solutions market include BioClinica Inc., CRF Health, DATATRAK International Inc., eClinical Solutions Inc., MaxisIT Inc., Medidata Solutions Inc., Merge Healthcare Inc., OmniComm Systems Inc., Oracle Co., and PAREXEL International Co.
eClinical solution software is a combination of applications, technology, and services that work together to aid in automated data management and collection of clinical trials with the aim of replacing paper-driven and manual methods. eClinical solution software has gained significant traction as an industry tools to reduce development costs, manage data requirements, support faster decisions for potential new products, and increase efficiency throughout the clinical trial process. The use of eClinical solutions in clinical trials is required to comply with regulations and regulatory guidance known as good clinical practices (GCPs) along with guidance from the FDA, foreign governments, and non-governmental organizations such as the International Conference on Harmonization (ICH).
Increasing number of clinical trials in emerging economies due to lower operational costs is expected to boost demand for eClinical solutions software. For instance, data from ClinicalTrials.gov, showed that, in 2017, 36% of clinical trials were conducted in the U.S. and 47% in non-U.S. countries. Clinical trial data is significant for the quick development of new treatments in a cost-effective manner. It is the most valuable asset for life sciences companies. Companies outsource the intense administrative parts of research and regulatory and ethics filings, to international countries for economical expenses and reducing cost and time. Developing nations can often offer access to a larger number of patients, with quicker enrollment, and in general a shorter trial timeline from start to finish. Moreover, increasing number of clinical trials for various chronic diseases such as cancer is expected to fuel growth of the eClinical solutions market.
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