The Global
Clinical Trial Management System Market is expected to grow
at a rate of 14% by 2026.Rising number of decentralized clinical
trials, adoption of CTMS in clinical trials, higher integration of CTMS with
other systems such as hospital information systems (HIS), surge in clinical
trial outsourcing, increasing investment by biotechnology & pharmaceuticals
firms, and rising government support & funding for research trials are some
of the key factors driving the clinical trial management system market growth.
However, limited private funding for small & mid-sized companies for
running clinical trials and the higher costs associated with overall clinical
trials (Phase I – Phase III) are likely to hamper the growth of this market.
A clinical trial management system (CTMS) is a software
system used to manage all of the activities related to the setup, conduction,
and closeout of clinical trials, including planning, preparation, tracking,
monitoring, compliance, and reporting. The system aims to manage and maintain
the tracking of patient data. Many clinical trial management systems are
web-based, making them easy to use across multiple sites with a large group of
users and also incorporate different components consisting of software, hardware,
and services.
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The clinical trial management system is the system of record
for study data, which can be shared with other systems according to the study
protocol and empowers organizations and research centers to enhance the
productivity and effectiveness of clinical trials by advancing and managing
clinical trials. Often, clinical trial management systems share data with
business intelligence (BI) system, which acts as a digital dashboard for
clinical trial managers. By centralizing data and automating processes, a clinical
trial management system makes clinical trial information more accessible and
transparent. A CTMS can be used for all four phases of a clinical trial.
Growing adoption of CTMS among Researchers and Sponsors
The implementation of a clinical trial management system
promises various advantages both for researchers and sponsors. With an
effective CTMS in place, data management is simplified, financial transparency
is ensured, resources are optimized, and errors are prevented. This easily
accessible, web-based system allows research staff to focus less on the
administrative work and more on direct patient care. Investigators and research
coordinators spend less time manually entering data into multiple locations, which
ultimately reduces errors made within a trial. CTMS also facilitates research
reporting according to CDISC standards and proper budget calculations help
conduct trials on time and keep the information up to date. Additionally,
having a centralized location for all documents reduces the need for duplicate
data entry and enables the research staff to easily identify any missing
documents thus improving study start-up times. A CTMS ultimately streamlines
workflow and improves productivity and overall efficiency within a clinical
trial.
A Shift towards Cloud-based Clinical Trial
Management System
Pharmaceutical companies have been operating in the cloud
for over a decade. The cloud-based CTMS model is expected to grow significantly
in the coming years due to its flexibility, efficiency, data security,
reliability, real-time visibility, scalability, and centralization. A
cloud-based CTMS can be deployed quickly to facilitate a complete clinical
trial cycle. Additionally, using cloud-based EDC (Electronic Data
Capture) software data can be captured from multiple sources, stored, and
processed in one central platform, enabling more efficient data monitoring,
reporting, and enhanced communication and collaboration. Furthermore,
cloud-based CTMS also 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. For Instance,
- 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
February 2021, eClinical Solutions LLC, a global provider of cloud-based
enterprise software and software-driven clinical data services, launched
Elluminate CTMS for life sciences companies to support drug development.
Benefits Associated with Clinical Trial Management System
Fuels Its Market Demand
The CTMS provides an extensive range of functionality that
strengthens the conduct of clinical trials. Many research sites, institutions,
sponsors, and CROs use these systems to monitor clinical trials. As clinical
trials become increasingly complex, any site, health system, or network can
benefit from the capabilities a CTMS provides such as:
- Compliance
with all legal protocols, guidelines, and standards
- Proactive
risk identification
- Greater
visibility & oversight
- Increases
data management efficiency
- Makes
it easier to deliver the information in a secure, legal way
- Monitors
trials’ progress, by generating detailed reports
- Offers
a secure, centralized location for data collection, storage, and
retrieval
- Prevents
enrollment in multiple trials
- Keep
track of a study’s financial data, ensuring accurate invoicing for
sponsors and proper payments for each site
North America Leads the Adoption of Clinical Trial
Management System Market
From a geographical perspective, North America holds a major
market share of the CTMS market. This can be mainly attributed to the
increasing number of clinical trials & studies, favorable regulatory
policies, increasing prevalence of chronic diseases, rising investments by key
players to develop advanced products, and the rising R&D expenses of
contract research organizations (CRO) and clinical study sponsors in the
region. However, APAC is expected to witness strong growth in the coming years,
due to increased funding from government and private organizations to support
clinical trials, low operating cost for conducting clinical research studies,
availability of a large patient base for clinical trials, and a growing number
of pharmaceutical companies in this region.
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Competitive Landscape Analysis: Clinical Trial Management
System Market
Some of the key players operating in the clinical trial
management system market include Oracle Corporation, Bio-Optronics, MedNet
Solutions, Parexel International Corporation, Medidata Solutions, BioClinica,
IQVIA Inc., Datatrak International Inc., Clario, SimpleTrials, Calyx, RealTime
Software Solutions LLC, Labcorp, Veeva Systems, Pharmaseal, IBM Corporation,
Advarra Technology Solutions, OpenClinica, ArisGlobal LLC, DZS Clinical
Services Inc, Crucial Data Solutions, and Ennov, among others.
Companies Adopting Inorganic Growth Strategies to
Increase their Market Share in CTMS Market
Players operating in the clinical trial management system
market are adopting both organic and inorganic growth strategies such as
collaborations, acquisitions, funding, and new product launches to garner
market share. For instance,
- In
October 2021, Parexel, a leading global clinical research organization,
and Kyoto University Hospital announced a strategic alliance focused on
offering better opportunities for clinical research and providing
efficient methods of supporting clinical studies. Kyoto University
Ki-CONNECT trial management platform conducts clinical trials for cancer,
intractable diseases, and regenerative.
- In
September 2021, PHARMASEAL International Ltd. and Medrio Inc. entered into
a collaboration to integrate Medrio's eClinical data collection suite with
PHARMASEAL's trial management platform, Englity.
- In
August 2021, Verily, an Alphabet subsidiary announced the acquisition of
SignalPath, a clinical trial management system (CTMS) based in Raleigh,
North Carolina, that improves the accessibility, quality, and efficiency
of clinical research at study sites.
- In
June 2021, 4G clinical secured over $200 million in a growth equity round
led by Goldman Sachs. 4G creates software to run the back-end of a
clinical trial. With the funding, 4G Clinical is looking forward to
benefiting from the increased public attention to the clinical trials
process, and the flexibility that the pandemic has created for sponsors to
get creative with clinical trial designs.
The global clinical trial management system market is a
growing market that is expected to gain further momentum in the coming years
due to software advancements, stringent government regulations, new product
launches, funding from private equity, capital ventures, and aggressive organic
and inorganic growth strategies followed by the players.
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