Clinical research is medical research involving people. Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
Clinical research is of two types, observational studies, and clinical trials. Observational studies observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. These studies may help identify new possibilities for clinical trials.
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
- A Phase I trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage.
- A Phase II trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years.
- A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
- A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.
Clinical trial management system (CTMS)
Investigators and their study teams are responsible for implementing and managing many aspects of their study operations. As a result, the ability to effectively manage clinical research varies across teams depending on funding and resource availability.
Currently, institutions use multiple disparate systems and document management tools for study subject management, research regulatory compliance, reporting, study data capture, sponsor invoicing, research billing, and research administration. These systems are incredibly labor intensive to maintain and require manual inspections to ensure that documents are appropriately tracked and updated. Report development additionally requires a significant effort in data reconciliation to create consistent and defensible reports.
A clinical trial management system (CTMS) is a software system used to manage clinical trials in clinical research. This CTMS will serve as a single, centralized, web-based enterprise resource to support clinical research studies conducted within or across the institutions. The CTMS is a critical tool for improving clinical research process.
Clinical trial management system is both cost and time effective, as these are employed to collect and organise data and can be shared with several care providers and dispersed across multiple systems. These technologies can help with site identification and recruiting, as well as control and tracking of participant enrolment and the database of participants. Therefore, increasing clinical trial volume is contributing to the rising market demand for such CTMS solutions to effectively manage the clinical studies.
With the increasing clinical trials activity and multi-site clinical trials gaining momentum, a need for effective tools to manage the studies with ease, maintain data with accuracy and manage the operational aspects of clinical studies also increases. Using software-based tools enables the sponsors to manage clinical trials efficiently.
The CTMS will:
- Improve the experience for patients on clinical trials.
- Strengthen research study reporting.
- Simplify research study billing compliance.
- Improve management of research study financials.
- Improve study subject management.
- Improve implementation and timelines of research.
CLINICAL RESEARCH MANAGEMENT
The system enables management of many aspects of clinical research including: study start-up timelines, tracking and reporting of protocol information and accrual data, study financial management and billing compliance.
The CTMS allows for shared study calendars, centralized & standardized billing processes including sponsor invoicing and subject visit tracking.
INTEGRATIONS / INTERFACES
The CTMS will integrate with Epic to facilitate patient data transfer from the clinic to the CTMS and will incorporate other study-related modules like ePRMS to support Scientific Review Committee processes.
REPORTING / ANALYTICS
The CTMS provides robust and streamlined reporting to meet NCI protocol and accrual reporting requirements, to support billing and financial operations, and to track trial start-up timelines.
Clinical Trials Management System Market
The clinical trials management system market size was valued at USD 1.50 billion in 2021 and is estimated to reach a CAGR of 13.9% from 2022 to 2030, owing to the rising focus of the healthcare sector in research and development activities worldwide. Many large-scale pharmaceutical and biotech industry participants are noted to be engaged in constant research in order to develop novel products as well as to sustain in the market. For instance, according to the UNESCO Institute for Statistics (UIS), in 2021, the global R&D investment surpassed USD 1.7 trillion. Around ten countries accounted for nearly 80% of all R&D spending.
Drivers and Constraints
Several countries have committed to further enhance the public and corporate R&D spending, as well as the number of researchers, by 2030 as part of the Sustainable Development Goals (SDGs). Furthermore, one of the primary value drivers for research-based pharmaceutical businesses is innovative medications addressing the unmet medical needs.
The rapid growth of healthcare IT, preference for decentralized clinical trials, initiatives by key companies, and the increasing number of clinical studies, are anticipated to drive the growth of the market.
The number of clinical trials has significantly increased in the past two decades. This is because of increasing penetration of cutting-edge medical technologies coupled with the rising demand for innovative medications with higher efficacy. According to the WHO, about 65,409 clinical trials were conducted in 2020 across the globe. This number was notably greater than the 60,543 trials conducted in 2019.
For instance, as of June 2022, according to the U.S. National Library of Medicine, 419,632 clinical studies were registered globally, with nearly 77% interventional studies and 22% observational studies. Also, according to the WHO International Clinical Trials Registry Platform (ICTRP), during the period 1999-2021, the U.S. (157,618) had the maximum clinical trials registered, followed by China (80,333), and Japan (57,754).
The high costs associated with clinical trial management system can potentially limit its market growth. Procurement, installation, and maintenance cumulatively surge the overall cost required for the adoption of CTMS solutions. On premise and SaaS-based systems both include installation fees. Additional setup, customization costs are charged to companies based on the distinctive organizational and study-specific demands. There are different cost structures observed with respect to number of users and number of sites under consideration. Certain contract or commitment term fees also need to be considered for CTMS along with periodic maintenance and upgradation of systems.
This is estimated to boost demand for CTMS solutions. Owing to enormous growth in R&D activities, having essential tools to plan, manage and track clinical studies effectively is need of the hour. Hence, eClinical solutions, such as clinical trial management system (CTMS), are gaining market prominence.
The COVID-19 pandemic significantly impacted the Clinical Trials Management System (CTMS) market. This included disruption in clinical trials, hurdles in patient recruitment, and canceled or delayed studies. However, the negative impact was gradually reduced by several strategic measures taken by governments, regulatory bodies, and market stakeholders to ensure continuity of R&D. The need to develop a vaccine for the coronavirus also boosted the adoption of decentralized clinical trials.
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) released guidelines to urgently advance COVID-19 vaccine equity. The IFPMA reported that 5 of its members had received approval for COVID-19 vaccines while 14 more were under clinical development. Also, as per COVID-NMA (an initiative by WHO), over 750 studies were registered for COVID-19 vaccine development as of February 2022. This is expected to increase the adoption of CTM systems.
To conduct clinical trials smoothly in the healthcare and life science industry, where physical access to patients was not possible, using new ways for patient monitoring and caring had become necessary. Due to this the previously present data collection methods, CTMS which were not utilized before, were quickly adopted in clinical trials during COVID outbreak.
In a study published in the U.S. National Library of Medicine in 2020, the pandemic resulted in delayed subject enrollment and operational gaps in most ongoing clinical trials. This in turn negatively impacted trial programs and data integrity. Globally, most sites conducting clinical trials other than COVID-19 were found to experience delays in timelines. In some cases, clinical trials were found to reach a complete halt of operations, thus impacting clinical research outcomes. In March 2020, the U.S. FDA published a guidance document on the Conduct of Clinical Trials of Medical Products during the pandemic. Similar guidelines supported the recovery of the clinical trial operations and the number is anticipated to increase over time.
Rising government funding and investments by biotechnology and pharmaceutical firms are promoting medical research activities. This factor combined with technological advancements is anticipated to boost the market growth during the forecast period. For instance, cloud-based CTMS eliminates the expenses of hardware acquisition, installation, provisioning, maintenance, support, and software licensing. These systems automatically update software and patch management systems, which reduces the burden of in-house IT staff and saves costs. Furthermore, the cloud-based software enables access to the server through mobile with maximum data security.
The increasing number of decentralized clinical trials is anticipated to boost market growth in the coming years. These are also referred to as virtual, digital, mobile, site-less, and remote trails that often utilize telemedicine solutions. Labcorp decentralized clinical trials (DCTs) solution for instance offers a suite of solutions to design and implement decentralized clinical trials including the necessary infrastructure, technology, and services. Increasing product availability from key companies is also estimated to fuel the market growth. Rave CTMS by Medidata for instance offers an intelligent automation and workflow management solution to efficiently manage and oversee clinical trials.
Delivery Mode Insights
Web & cloud-based systems held the largest share in 2021 owing to benefits such as remote access to data and minimal technical issues. These are the most preferred CTM systems. They help minimize costs associated with system security, backups, upgrades, and uptime consistency. Furthermore, web & cloud-based systems support the storage of large amounts of data as well as centralization of data, which facilitates access to data from any location. These factors are expected to drive growth during the forecast period.
The segment is also anticipated to exhibit the fastest growth during the forecast period. This is owing to the increased adoption of AI, analytics, and machine learning algorithms. The advanced automation thus contributes to the increased utility of web & cloud-based solutions. The technology comprises three services such as Platform as a Service (PaaS), Infrastructure as a Service (IaaS), and Software as a Service (SaaS). Cloud-based technology offers greater study control to CTMS, wherein the clinical trial managers can manage location and other research study requirements in real-time. Another advantage is access to data from any device such as mobile, workstations, laptops, and tablets through software.
Based on component, the market for clinical trial management system is classified into software and services. The software segment accounted for USD 897.3 million revenue in 2021 and is expected to dominate from 2022 to 2030 due to its high utilization and increased adoption in clinical trials. Various biotechnology, pharmaceutical companies and other life science organizations promoting research constantly conduct complex clinical trials. These trials are aimed at discovering novel medicines and medical devices.
The highest share of the global Clinical Trials Management System (CTMS) market by component was held by the software segment. The services segment on the other hand is estimated to grow at a notable rate in the coming years. The software helps perform critical functions such as comprehensive management of trial planning, country and site progress, monitoring activities, regulatory procedures, supplies, and finance. These are deployed mostly on a subscription basis at enterprise or site levels. Periodic software upgrades and add-ons may also add to the revenue.
In addition, an effective CTMS software solution can help pharmaceutical and medical device companies comply with regulatory norms, which helps accelerate market entry. Hence, the software segment dominates the market as it helps to streamline and fine-tune the document management processes, which can otherwise compromise the data quality and participant safety. Clinion for example provides comprehensive software for clinical trial setup and management. The software comes with a host of integrated offerings including CTMS, IWRS/RTSM, EDC, and eCOA to meet the needs of small and medium companies.
Solution Type Insights
Enterprise accounted for the largest share of the market by solution type and is also expected to expand at the fastest CAGR during the forecast period. The key factors contributing to this share include associated benefits such as end-to-end insights into the operational activities such as accruals and deviations, scalability of the solution, robust reporting, enhanced billing compliance, and tracking and management of regulatory processes.
Real Time’s Enterprise CTMS for example, offers a comprehensive solution for centralizing recruitment, regulatory, resource, accounting, and aggregate reporting across large site networks, universities, and hospitals. The network-wide visibility and oversight provided by enterprise-level solutions present an ideal solution for large biopharmaceutical companies and CROs.
By end-user, pharmaceutical, and biotechnology firms held the largest share of over 40% of the market in 2021. CTMS plays a vital role in drug discovery by improving workflows, reducing costs, and speeding up the overall clinical trial process. The pharmaceutical and biotechnological firms segment occupies the largest revenue share in the CTMS market. This growth can be attributed to the rising adoption of CTMS end-users to store data, sync records, and manage the large number of clinical studies conducted every year.
The others segment is anticipated to grow the fastest. It comprises contract research organizations (CROs), academic research organizations, and others. The growth of this segment is attributable to the increased outsourcing of clinical trials as well as a rise in the number of decentralized clinical trials. Clario for instance offers solutions for all trial models: site-based, decentralized, and hybrid clinical trials. It generates rich, diverse, and reliable evidence via its 30 facilities spread across 9 countries in North America, Europe, and the Asia Pacific.
North America held over 50% of the market in 2021. The large share of the North American region can be attributed to the presence of key companies the and rising adoption of technology in R&D. Favorable regulatory policies and increasing investment by the pharmaceutical companies can also be attributed to this regional growth.
Asia Pacific is estimated to expand at the fastest CAGR in the next few years. This is owing to increasing R&D activities in the region, the availability of a large patient pool, an increasing number of clinical trials conducted across the region, and the outsourcing of clinical trials. Asian countries offer a less expensive process for clinical research studies. This factor is anticipated to boost the regional market during the forecast period. Latin America is another emerging market for clinical trials. As per clinical trials.gov, an increasing number of clinical trials are being conducted in Latin American countries including Mexico, Brazil, and Argentina.
Some of the key players in the clinical trials management system (CTMS) market include: IQVIA Inc., Medidata Solutions, Inc., Oracle, DATATRAK International, Inc., Clario, SimpleTrials, Calyx, RealTime, Labcorp, Veeva Systems, Wipro Limited, PHARMASEAL Clinical Tr
in February 2021, eClinical Solutions LLC launched Elluminate CTMS for life sciences companies to support drug development. In June 2016, Oracle announced that Pfizer has selected Oracle Health Sciences InForm Cloud Service and the Oracle Siebel Clinical Trial Management and Monitoring Cloud Service to manage and monitor its 300+ clinical trials a year. In March 2021, Peachtree BioResearch Solutions, Inc.— a CRO serving emerging mid-sized companies adopted Oracle Health Sciences Cloud Services and the Siebel Clinical Trial Management System (CTMS) to streamline clinical trials start-up and monitoring.
In November 2021, a clinical endpoint technology leader— ERT merged with Bioclinica to form Clario. This enabled the company to technology-based based therapeutic area solutions to meet clinical trial objectives.
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