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.
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.
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.
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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.
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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.
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.
An Adaptive Approach to Modern-day Research Needs
A recent market study published by the company “eCOA, eSource & Clinical Trials Market: Forecast, Trend Analysis & Competition Tracking- Market Review 2014-2029” consists of a comprehensive assessment of the most important market dynamics.
Upon conducting thorough research on the historic as well as current growth parameters of the eCOA, eSource & Cclinical trials market, the growth prospects of the market have been obtained with maximum precision. The report features the unique and salient factors that will have a significant impact on the development of the eCOA, eSource & clinical trials market during the forecast period.
The report will also help market players to modify their manufacturing and marketing strategies to envisage maximum growth in eCOA, eSource & Clinical Trials market in the upcoming years. The report provides detailed information about the current and future growth prospects of the eCOA, eSource & Clinical Trials market in a comprehensive manner for the better understanding of the readers.
Chapter 01 – eCOA, eSource & Clinical Trials Market - Executive Summary
The report commences with an executive summary of the eCOA, eSource & Clinical Trials market report, which includes a summary of the key findings and key statistics of the market. It also includes the market spending (US$ million) estimates of the leading segments of the eCOA, eSource & Clinical Trials market and market trends.
Chapter 02 – eCOA, eSource & Clinical Trials Market - Market Introduction
Market introduction comprises detailed market definitions. Readers can find detailed taxonomy and the definitions associated with the eCOA, eSource & Clinical Trials market in this chapter, which will help them gather the basic information about the eCOA, eSource & Clinical Trials market.
Chapter 03 – eCOA, eSource & Clinical Trials Market - Key Trends
Market key trends include supply side trends and demand side trends for the eCOA, eSource & Clinical Trials market by region, macro-economic factors, and regulatory scenario for eCOA, eSource & Clinical Trials across regions.
Chapter 04 – eCOA, eSource & Clinical Trials Market - Key Success Factors
This section provide insights on the eCOA, eSource & Clinical Trials solution adoption and Recent deals.
Chapter 05 – eCOA, eSource & Clinical Trials Market Volume Analysis, 2014–2018 and Forecast 2019–2029
This section provide provides volume analysis for ECOA, eSource & Clinical Trials market.
Chapter 06 – eCOA, eSource & Clinical Trials Market Context
This section provide provides some key parameters and trends in the eCOA, eSource and & Clinical Trials Market. Some of the inclusions in this segment are Clinical Trails patient journey, digitization of clinical trials, EDC data flow- paper v/s digital, Return on investment, traditional process v/s eCOA integration process. Evolution of RTSM technology and terminology, and key market regulations that affect the market growth.
Chapter 07 – Global eCOA, eSource & Clinical Trials Spending 2014-2018 and Opportunity Assessment, 2019-2029
This section provide value analysis for eCOA, eSource & Clinical Trials market spending at a global level.
Chapter 08 – eCOA, eSource & Clinical Trials Market - Market Background
This section contains major indices for the ECOA, eSource & Clinical Trials market. Some of them include the eCOA, eSource & Clinical Trials market trends, drivers, opportunities, and restraints.
Chapter 09 – Global eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029, by Solution Type
This section covers the eCOA, eSource and Clinical Trials Spending by solution type. The segments covered in this section include, eCOA, eSource, Clinical Trial Solutions and EDC market spendings.
Chapter 10 – Global eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029, by Deployment
The deployment segment of the eCOA, eSource & Clinical Trials market is segmented into licensed enterprise and cloud based solutions.
Chapter 11 – Global eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029, by End User
The End User segment of the eCOA, eSource & Clinical Trials market is segmented into Contract research organizations, hospitals and other healthcare facilities, pharmaceutical/biothech/medical device companies and educational and research institutes. This section provides the reader a global insight on the eCOA, eSource & Clinical Trials market by the end user.
Chapter 12 – Global eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029, by Region
By region, the eCOA, eSource & Clinical Trials market is segregated into 7 major regions, namely North America, Latin America, Europe, South Asia, East Asia, Oceania and the Middle East and Africa. In this chapter, readers can find information about the key trends and developments in the eCOA, eSource & Clinical Trials market and the market attractive analysis for individual regions pertaining to the solution type, deployment, end user, and regions in the eCOA, eSource & Clinical Trials market.
Chapter 13 – North America eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029
This chapter includes a detailed analysis of the growth of the North America eCOA, eSource & Clinical Trials market, along with the country-wise assessment for the U.S. and Canada. Readers can also find information about the regional market growth based on the solution type, deployment, end user and countries in the North America region.
Chapter 14 – Latin America eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029
Readers can find detailed information about factors, such as the key regulations and regional trends that are impacting the growth of the Latin America market. This chapter also discusses the growth prospects for the eCOA, eSource & Clinical Trials market. Drivers and restraints impact analysis for various forecast factors for the region is also given in this section.
Chapter 15 – Europe eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029
The growth prospects of the eCOA, eSource & Clinical Trials market are based on product type, MR dimension and end user in several European countries, such as the U.K., Germany, France, Italy, Spain, Russia and Rest of Europe have been included in this chapter. Country-wise market size and market attractiveness index has also been included in this section.
Chapter 16 – South Asia eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029
India, Malaysia, Indonesia, Thailand are the leading countries in the South Asia region, which are the prime subjects of assessment to obtain the growth prospects of the South Asia eCOA, eSource & Clinical Trials market in this chapter.
Chapter 17 – East Asia eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029
China, Japan and South Korea are the leading countries in the East Asia region, which are the prime subjects of assessment to obtain the growth prospects of the East Asia eCOA, eSource & Clinical Trials market in this chapter.
Chapter 18 – Oceania eCOA, eSource & Clinical Trials Spending (US$ Mn) Analysis & Forecast 2014-2029
Australia & New Zealand are the leading countries in the Oceania region, which are the prime subjects of assessment to obtain the growth prospects of the Oceania eCOA, eSource & Clinical Trials market in this chapter.
Chapter 19 – Middle East and Africa ECOA, eSource & Clinical Trials Market Analysis 2014–2018 and Forecast 2019–2029
This chapter provides information about how the market will grow in the major countries of MEA region, such as GCC, Turkey, and South Africa during the period 2014–2029. Country-wise market size and market attractiveness index has also been included in this section.
Chapter 20 – Emerging Countries ECOA, eSource & Clinical Trials Market Analysis 2014–2018 and Forecast 2019–2029
This chapter provides information about how the market will grow in the major countries, such as China, India and Brazil during the period 2014–2029. Country-wise market size and market attractiveness index has also been included in this section.
Chapter 19 – Market Structure Analysis
This section covers all the market structure for the manufacturers in the eCOA, eSource & Clinical Trials market. The manufacturers are classified into tiers on the basis of their revenue generation for the eCOA, eSource & Clinical Trials.
Chapter 21 – Competition Analysis
This section covers the competition dashboard for all the key manufacturers in the eCOA, eSource & Clinical Trials market. The company profiles for various key manufacturers are also mentioned in this section. Company profiles includes are, OpenClinica LLC, CRF Health Inc, ERT Clinical, Medldata Solutions, Inc, ArisGlobal LLC, HealthDiary Inc, ICON Plc, PAREXEL International Corporation, OmicComm Systems Inc, Medrio Inc, Medable, Oracle Corporation, Medspace Holdings Inc, Covancce Inc, and Bio-Optronics Inc.
Chapter 22 – Assumptions and Acronyms
This chapter includes a list of acronyms and assumptions that provide a base to the information and statistics included in this report.
Chapter 23 – Research Methodology
This chapter will helps readers understand the research methodology followed to obtain various conclusions and important qualitative & quantitative information about the eCOA, eSource & Clinical Trials market.
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