Introduction
Several players are operating in the global eClinical solutions market. In 2017, the global eClinical solutions market was held by various prominent companies such as Parexel International Corporation, BioClinica, Inc., Oracle Corporation, and Medidata Solutions, Inc. The prominent players in the market are adopting a couple of growth strategies such as new product launches, strategic partnerships and collaborations, operational and geographical expansions, and mergers and acquisitions to gain competitive advantage.
Oracle Corporation is a California-based company and accounted for 15.10% of the global eClinical solutions market share in 2017. The company operates in all the major markets across the world and serves its customers in North America, South America, Europe, Asia-Pacific, and the Middle East and Africa. The company operates through its life sciences segment and provides clinical trial management and clinical data management. Oracle Corporation majorly adopts inorganic growth strategies such as mergers and acquisitions.
Medidata Solutions, Inc. accounted for the second-largest market share of 10.03% in 2017. It is a US-based technology driven company that provides cloud-based solutions for life sciences companies. The company is engaged in the development and distribution of clinical cloud platforms for conducting clinical trials as well as the development of new therapies and offers services such as implementation, strategic consulting, partner support, sponsor enablement, and e-learning and training. It has a strong network in all the major markets and has offices in the US, the UK, Japan, China, South Korea, and Singapore. In February 2019, the company entered into a strategic partnership with Cognizant to develop clinical solutions related the cloud-based clinical development.
ERT Clinical is a global data and technology company which helps minimize risk in clinical trials. The company operates through business segments, namely, cardiac safety solutions, eCoa solutions, respiratory solutions, imaging solutions, trial oversight, business intelligence, post-approval, patient support programs, and provides technology, services, and clinical consulting to other companies.
BioClinica, Inc. provides scientifically driven services and technology-enabled services to pharmaceutical and biotechnology companies. This New Jersey-based company conducts clinical trials and provides assistance related to medical image management, electronic image transport and archive solutions, electronic data capture, clinical data management, interactive voice and web response, clinical trial supply forecasting tools, and clinical trial management software solutions. It is focused on internal research and external alliance through strategic collaborations.
Parexel International Corporation is a biopharmaceutical services company which provides expertise in clinical research, medical communications, commercialization, and advanced technology products and services to the worldwide pharmaceutical and biotechnology industries. It focuses on acquisitions and collaboration strategies to expand its operational and geographical presence.
Apart from these companies, there are a large number of companies operating in the global eClinical solutions market. Some of these companies include Datatrak Int., Merge Healthcare Inc., Omnicomm Systems, Inc., and MaxisIT.
Michael Porter’s five forces model gives a framework that models the global eClinical solutions market, which is influenced by five forces. The strategic business managers, trying to create an edge over competing firms in the global eClinical solutions market can utilize this model to comprehend better the industry connection in which the firm operates. The components of each of the forces and the degree or impact of each component in the context of the global eClinical solutions market have been broken down and analyzed.
Threat of New Entrants
The threat of new entrants is low to moderate in the global eClinical solutions market. Any contract development and manufacturing company trying to enter the market is required to accept or abide by the mandatory regulatory standards. However, the budget required for the development of the clinical trial platform is high as compared to other industries. eClinical solutions are specialized and developed to be used to conduct clinical trials and to collect clinical trial data with ease. Moreover, the majority of the customers are using technology platforms developed by trusted providers, and they are likely to prefer established brands over new market player due to quality concerns and to maintain the quality of the final product, which does not comfort the new entrants to enter the market easily.
Bargaining Power of Suppliers
The suppliers in the global eClinical solutions market are clinical trial software and technology platform developers. There are various suppliers present in the global eClinical solutions market. Switching cost of these suppliers is low due to intense competition. However, research and development cost required for the development of software is quite high. Moreover, suppliers are likely to enter into long term partnerships with pharmaceutical companies and involved in more than one projects with the same company. Due to the increasing research and development activities in the pharmaceutical industry and entry of major pharmaceutical companies in the emerging markets, a large number of customers are available.
Moreover, several suppliers are there to cater to the needs of the customers which lead to intense competition between the existing suppliers. However, the development of easy to use the software is a tough task and software should provide accurate information regarding clinical trial. Hence, CRO’s and major pharmaceutical companies are selective about suppliers. Due to this, the overall bargaining power of suppliers in the global eClinical solutions market is moderate.
Bargaining Power of Buyers
The bargaining power of buyers is moderate to high in the global eClinical solutions market. The market has many buyers and a limited number of eClinical solutions providers to cater to the need of the buyers. However, the eClinical solutions are specialized and play an important role in pharmaceutical product approvals, and the buyers of the eClinical solutions are moderately inclined towards quality platforms developed by trusted companies. As the technology platforms and software are used for clinical trials and customized according to the need of the limited client substitutes available in the market. Also, most of the buyers are pharmaceutical companies and research organizations; they are likely to enter into the long-term agreements with the eClinical solutions providers for uninterrupted service. Moreover, they can exert pressure on the developers due to the low switching cost and intense rivalry in the market, which is responsible for the increased bargaining power of buyers.
Threat of Substitutes
The threat of substitutes in the global eClinical solutions market is low to Moderate. EClinical solutions are used in clinical for the systematic gathering of data from different sources. There are limited options available in the market to serve the need of the customers and which eliminates the threat of substitute. However, the increasing research and development activities and demand for efficient technology platforms are likely to provide new substitutes to the eClinical solutions. Also, the high degree of customization decreases the threat of substitutes. The overall threat of substitutes in the global eClinical solutions is low to moderate.
Intensity of Rivalry
The rivalry in the global eClinical solutions market is moderate to high. The low degree of product differentiation and a limited number of customers increases the intensity of rivalry in the market. The market is growing with a prominent growth rate and likely to provide opportunities for major players to expand their geographical boundaries which will initiate cutthroat competition between major players to capture maximum market share in the emerging markets. Players are engaged in developing a process to lower their development cost to increase profitability and to overcome the competition. Moreover, they are also developing advanced platforms for differentiating their brand from their competitors.
Regulatory Framework
Clinical trials are research studies conducted to test new therapeutic options for the treatment of medical complications or disorders and to evaluate the medical, surgical, or behavioral intervention. Clinical trial studies are conducted to check the safety and efficacy of a drug or a medical device. There are various steps and rules and regulations involved in the clinical trial process. Nowadays many major players are conducting clinical trials in emerging countries and developing new treatments. Clinical trials are of two types, namely, therapeutic or non-therapeutic trials. Clinical trial organizations are facing numerous challenges to maintain standardization and transparency in the process, which is encouraging the use of eClinical solutions. eClinical solutions are useful in maintaining end-to-end transparency throughout all facets of the process, including financial data, patient care, compliance with federal regulatory standards, and employee scheduling.
Regulatory authorities are responsible for the evaluation and validation of clinical trial and data generated by it. ICH E6 guidance offers a list of necessary documents required to submit before clinical trial starts, in between the trial and after completion of the trial.
Documents required to submit to the regulatory authorities while conducting clinical trials are as follows:
Before Trial Documents: Investigator's brochure, case report form, protocol, subject materials, Institutional Review Board approval documentsDuring Trial Documents: Completed case report forms, updates to investigator's brochure and other documents, monitoring visit reports, subject logs, continued IRB approval documentsAfter Trial Documents: Clinical study report, final closeout monitoring report, final report to the Institutional Review Board
