eCOA, eSource & Clinical Trials Market Industry Assessment & Opportunity Forecast till 2029

Published: Thu Sep 12 2019

Paper-Based to Paper-Less – The Shift in Clinical Trials Underway

Clinical trials lay the foundation for the functionality of pharmaceutical companies that have been witnessing continuous high pressure to meet the accelerating demand for safe and effective treatments at justifiable prices. With so much at stake, healthcare facilities, medical device companies, and educational & research institutes have placed their focus on improving the efficiencies of clinical trials.

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Fact.MR analysis indicates that the change is already underway. Moreover, unprecedented demand for clinical trials in developing counties has been fueling the clinical trial expenditure.

Paper-based data collection represents a key issue for the accuracy of the data used for conducting clinical trials. As the entire clinical trial process is rigid and does not allow for much flexibility, organizations have to comply with strict protocols and the changes are tedious to implement. Additionally, patient adherence has emerged as a leading issue in the clinical trial processes in recent years, with 85% of them cited to fail at retaining enough patients. This has paved way for the adoption of novel technologies that have been cited to radically change the way clinical trials are conducted.

Several healthcare companies and governments are also taking initiatives to conduct clinical trials in a digital way to reduce lengthy timelines and high costs. The era of clinical trials as known to companies for years, is on the verge of coming to an end. Increasing costs of conducting a trial and the commercial risks of failure are becoming unsustainable. Such a disruptive state has already driven the adoption of novel technologies, thereby, catalyzing the digital transformation of clinical trials.

How Close the Industry Is to Changing Clinical Trials?

Clinical trials are witnessing a turmoil of changes as an increased number of pharma companies have placed their focus on addressing the growing concerns around efficiency. Unleashing the power of digitization through eCOA, eSource, and clinical trial solutions, companies have set their focus on streamlining clinical trials, enhancing R&D efficiency, and cutting costs of length processes. In view of the growing demand for timely launch of drugs, devices, and healthcare solutions, coupled with the growing stringency of regulations for product approval, it is highly likely to witness a paradigm shift in the clinical trial processes.

Fact.MR analysis estimated ~1,950 Mn global spending on eCOA, eSource, and clinical trials solutions in 2018, as an increased number of companies have started leveraging digital technology to increase the number of clinical studies, and develop and test more treatments simultaneously. Digitization in clinical trials has enabled pharma companies to expand their reach to remote and even smaller patient groups to create enhanced protocols to test treatments.

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While an increasing number of companies demonstrate an appetite for adopting advanced digital and mobile technologies, the eCOA, eSource, & clinical trials market spending is likely to grow in the forthcoming years. In July 2017, for instance, Mapi, a clinical outcome assessment provider formed an alliance with YPrime, a leading eClinical technology company to simplify deployment of validated assessments migrated onto YPrime's eCOA platform, which is installed on mobile devices.

Why Digitization will Disrupt Clinical Trials?

There is a growing demand for more clinical trials across more sites, and this need is set to proliferate in the years to come. As digital technologies could reduce clinical trial costs and streamline the processes, a large number of healthcare facilities and research centers have placed their focus on paper-less ways. This has further made clinical trials less about collecting protocol-defined data points, and more about leveraging data from patient records and various other electronic sources, such as devices and apps, and electronic interoperability. Several pharma companies and research centers are leveraging eSources, including Electronic Health Records (EHR), devices and apps, Non-Case Report Form (CRF), and direct data capture to streamline their clinical trial processes.

The Promise of Digital

As healthcare industry looks forward to ways that can enhance the performance of today’s clinical trial models, several companies have turned to digital technologies. Numerous benefits associated with the adoption of eCOA, eSource and clinical trial solutions for clinical trial operations continue to appeal to a wider pool of organizations to embrace digitization to cater to the increasing demand for faster and precise clinical trial processes. Moreover, patient engagement, which has been fundamental within a traditional clinical trial setting, also forms the basis of a virtual trial processes.

While various eCOA, eSource & clinical trial solutions continue to enable decentralized clinical trials that are less site-centric, organizations are seamlessly accessing hard-to-reach patient populations, while allowing the study patients to perform requirements independently away from the site. Several companies are taking initiatives in this direction to capitalize the potential rise in the demand for efficient and in-time completion of clinical trials. For instance, Ochsner Health System and Pfizer have collaborated to construct a digital superhighway for clinical trials. Together the companies have employed Fast Healthcare Interoperability Resources (FHIR) to quickly transmit data from the Electronic Health Records (HER) with an aim to enhance access to experimental therapies for clinicians and patients. Collaborations continue to remain the key strategy of stakeholders to move ahead in the highly competitive and fragmented market.

Dependency on Technology Is Itself a Challenge

Though it’s the right time for contract research organizations, healthcare facilities, pharmaceutical companies and education & research institutions to get in the game of digitization transformation, too much dependency on technology remains a risky bet for them. While some organizations are just adopting single tools or clinical trial solutions, others have disrupted the whole value chain to skim the cream from accurate and insightful results. However, privacy issues and excessive dependency on technology continue to hinder the deployment prospects of eCOA, eSource, and clinical trial solutions. Growing penetration of Bring Your Own Device (BYOD) trend in clinical trial aisles continue to pose a threat to safe transmission of data by healthcare providers.

Lack of internet connectivity is another key factor that is likely to impede the growth of the eCOA, eSource, and clinical trials market. Also, lack of interaction between healthcare professionals and patients can lead to errors in the clinical services delivered to the patients. Such factors continue to obstruct the deployment of clinical trial solutions, and use of eCOA and eSource during clinical processes. Moreover, demanding skills required for operating clinical trial solutions, such as Clinical Trial Management Systems (CTMS), Randomization and Trial Supply Management Systems (RTMS), Clinical Data Management Systems (CDMS), and trial planning and safety solutions remain a key area of concern for organizations.

What Organizations Need to Do to Stay on Top of Digitization?

Growing part of literature continues to indicate substantial increase in the costs of running clinical trials and an evident need to harness advancing technology to enhance certain processes. As clinical trial digitization offers a solution for a wide range of challenges that need to be addressed, an increased number of companies are scrapping paper ways to move ahead with time-effective and cost-effective approaches for clinical trials.

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Several pharmaceutical companies have been pushing for the development of eCOA solutions, in line with the mounting pressure to manage and reduce the overall costing of clinical developments and studies. eCOA and e-patient diaries have emerged as vital and better tools than paper for patients and healthcare providers to enhance clinical care. These factors continue to shape the growth of the eCOA, eSource & clinical trials market in a positive way.

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