#eclinical solutions

[insightfulblogz]

eClinical Solutions Market Analysis and Forecasts, 2024-2032

eClinical solutions refer to the software and digital tools used to streamline clinical trials and manage clinical data efficiently. These solutions include platforms for electronic data capture (EDC), clinical trial management systems (CTMS), and electronic health records (EHR), among others. eClinical solutions help pharmaceutical companies, contract research organizations (CROs), and healthcare providers enhance the efficiency of clinical trials, reduce costs, and ensure compliance with regulatory standards. As clinical trials become more complex and data-driven, the demand for robust eClinical solutions is increasing rapidly.

The eClinical Solutions Market Size was valued at USD 8.33 billion in 2022 and is expected to reach USD 22.94 billion by 2030 and grow at a CAGR of 13.5% over the forecast period 2023-2030.

Future Scope

The eClinical solutions market is expected to grow significantly, driven by advancements in cloud-based platforms and the integration of artificial intelligence (AI) and machine learning (ML) into clinical trial management. These technologies offer improved data analytics, real-time monitoring, and predictive insights, enhancing the efficiency of clinical trials. Additionally, the growing trend toward decentralized clinical trials (DCTs) and virtual trial models is expected to drive demand for eClinical solutions that support remote data collection and patient monitoring. As regulatory requirements become more stringent, eClinical solutions will play a critical role in ensuring compliance and data security in clinical research.

Trends

Several trends are emerging in the eClinical solutions market. The shift toward decentralized and virtual clinical trials is a key trend, as it allows for more patient-centric and flexible trial designs. The increasing use of AI and ML in eClinical platforms is also transforming the market by enabling more sophisticated data analysis and decision-making. Cloud-based solutions are becoming more popular due to their scalability, accessibility, and cost-effectiveness. Additionally, the growing emphasis on patient engagement and real-time data collection is driving the adoption of mobile health (mHealth) applications and wearable devices in clinical trials.

Applications

eClinical solutions are used across various stages of clinical trials, from study design and patient recruitment to data collection and analysis. Pharmaceutical companies, CROs, and academic research institutions use these solutions to manage trial workflows, track patient data, and ensure regulatory compliance. EDC systems, CTMS platforms, and eCOA (electronic clinical outcome assessment) tools are commonly used to collect and analyze data more efficiently. The use of eClinical solutions enables faster decision-making, improved patient safety, and more successful trial outcomes.

Key Points

eClinical solutions streamline clinical trials and improve data management efficiency.

The market is expanding with the adoption of cloud-based platforms, AI, and decentralized trial models.

Key trends include the rise of virtual trials, AI-driven analytics, and patient-centric mHealth solutions.

Applications span pharmaceutical companies, CROs, and research institutions for clinical trial management.

Enhanced data analytics, real-time monitoring, and regulatory compliance are key drivers of market growth.

Conclusion

The eClinical solutions market is poised for significant growth as technological advancements and the shift toward decentralized clinical trials drive demand for more efficient and scalable solutions. As the industry continues to embrace AI, cloud-based platforms, and patient-centric approaches, eClinical solutions will play a vital role in the future of clinical research. With increasing regulatory scrutiny and the need for faster, more accurate data management, the market is set to expand in the coming years.

[prajwal-agale001]

According to a report by Meticulous Research®, the eClinical solutions market is expected to reach $23.32 billion by 2031, growing at a CAGR of 13.9% from 2024 to 2031. This growth is driven by the increasing volume of data generated in the healthcare and life sciences sectors, a rise in clinical trials, supportive initiatives for clinical research, and growing funding for medical and pharmaceutical R&D. Strengthening IT infrastructures in large hospital chains and the rising demand for precision medicine are also expected to create growth opportunities. The market is segmented by products such as CDMS, CTMS, EDC, eCOA, ePRO, and safety solutions, as well as by clinical trial phases, end users like pharmaceutical companies and clinical research organizations, and geography.

[luckydige45]

The global market for eClinical solutions is estimated at USD 9.85 Billion in 2023 and is projected to reach USD 37.16 Billion by 2033, growing at a CAGR of 14.2% from 2024 to 2033. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions.

[rachvictor05]

Transforming Healthcare with eClinicalWorks EHR Integration Solutions

In the ever-evolving field of healthcare, seamless integration of electronic health records (EHR) is essential for enhancing patient care and operational efficiency. eClinicalWorks, a prominent provider of cloud-based healthcare solutions, offers advanced EHR integration solutions designed to unify disparate systems and streamline healthcare delivery. These solutions are pivotal in improving care coordination, data accuracy, and overall healthcare management.

eClinicalWorks integration solutions provide a comprehensive framework for connecting various healthcare technologies, including EHR systems, practice management software, and other clinical tools. This integration addresses a common challenge in healthcare: the fragmentation of patient information across multiple systems. By consolidating data into a unified platform, eClinicalWorks enables healthcare providers to access a single, comprehensive view of patient information, thereby eliminating data silos and improving decision-making.

One of the key benefits of eClinicalWorks EHR integration is the enhancement of care coordination. The platform allows for real-time access to critical patient data, such as medical histories, treatment plans, and diagnostic results. This centralized access facilitates better communication and collaboration among healthcare providers, which is essential for managing complex cases and ensuring continuity of care. For example, when a patient transitions between different care settings or specialists, eClinicalWorks EHR ensures that all relevant information is available to the new care team, supporting a more coordinated approach to treatment.

Interoperability is another significant advantage of eClinicalWorks EHR integration solutions. The platform is designed to integrate seamlessly with a wide range of external systems, including laboratory information systems, radiology information systems, and pharmacy management systems. This broad interoperability enables efficient data exchange and reduces the risk of errors associated with manual data entry. For instance, integration with laboratory systems allows for the automatic updating of patient records with test results, ensuring that healthcare providers have the most current information for clinical decision-making.

Additionally, eClinicalWorks EHR integration extends to administrative functions, such as scheduling and billing. By connecting EHR systems with practice management software, the platform streamlines scheduling, billing, and insurance claims processing. This integration reduces administrative burdens and enhances operational efficiency, allowing healthcare providers to focus more on patient care.

In summary, eClinicalWorks EHR integration solutions play a crucial role in transforming healthcare delivery. By providing a unified platform that enhances care coordination, supports interoperability, and optimizes administrative processes, eClinicalWorks helps healthcare organizations improve patient outcomes and operational efficiency. As the healthcare industry continues to advance, eClinicalWorks remains a key player in driving technological integration and innovation.

[industryforecastnews]

eClinical Solutions Market Size To Reach $22.7 Billion By 2030

The global eClinical solutions market size is expected to reach USD 22.7 billion by 2030, growing at a CAGR of 14.1% from 2024 to 2030, according to a new report by Grand View Research, Inc. Increasing R&D activities by biopharma and pharma companies, application of software solutions in clinical trials, and expanding customer base are anticipated to fuel market growth. During COVID-19, clinical laboratories experienced high demand for COVID-19 tests. Clinical data management systems assisted these laboratories to seamlessly manage the huge influx of specimens daily. Technological advancements such as electronic data capture and Wi-Fi connectivity are projected to drive the market in the forthcoming years.

As the demand for tracking and analyzing clinical data increases, the need for effective clinical solutions rises. Unmet needs to manage efficient clinical development processes are poised to boost market growth over the forecast period. Moreover, digital transformation in the field of clinical trials and preference for data-centric approaches are providing a tremendous push to the market. Demand for integrated clinical IT solutions is increasing due to the massive volume of data generated during clinical development processes. eClinical solutions offer a single source of information that helps optimize the cost by eliminating redundant data entry and by reducing on-site verification and source data verification. Rising awareness regarding these advantages is projected to propel the market.

Increasing adoption of eClinical workflows in trials offers enormous potential in clinical development processes. These solutions can facilitate decision-making in each stage of development. It helps reduce cost and time between the development phase by utilizing seamless designs and identifying failing compounds. It offers rapid access to data and patient safety information, which helps make quick decisions. Market players engage in new product development and strategic alliances including partnership, agreement, promotional activities, etc. to keep market rivalry high. In August 2023, Sitero acquired Clarios eClinical technology suite to enhance clinical trial delivery. This acquisition demonstrates Sitero's dedication to remain at the forefront of innovation and offering its clients the best possible support and services.

Request a free sample copy or view report summary: https://www.grandviewresearch.com/industry-analysis/eclinical-solutions-market

eClinical Solutions Market Report Highlights

Based on product, the CTMS segment led the market in 2023 and accounted for a revenue share of around 20.2% owing to benefits such as centralized end-to-end management of clinical trial activities, elimination of reliance on manual processes, real-time status tracking, and maintenance of multiple databases, which cumulatively improve the overall efficiency of clinical trials

Web and cloud-based systems are anticipated to exhibit an exponential CAGR during the forecast period owing to integrated features such as flexibility, high accessibility, negligible handling costs, and easy data backup. Real-time data is available through these systems, which enables users to take quick decisions and provide high-quality information for risk-based monitoring

Based on development phase, the phase III segment held the largest market share of 53.3% in 2023. Phase I segment is expected to grow at the fastest CAGR over the forecast period

Based on end-use, the CRO segment held the largest revenue share in 2023. The segment is projected to rise at a remarkable CAGR during the forecast period owing to the growing inclination of pharmaceutical companies to reduce overall expenditure.

eClinical Solutions Market Segmentation

Grand View Research has segmented the global eClinical solutions market based on product, delivery mode, development phase, end-use, and region:

eClinical Solutions Product Outlook (Revenue, USD Million, 2018 - 2030)

Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) 

Clinical Trial Management Systems (CTMS)

Clinical Analytics Platforms

Randomization and Trial Supply Management (RTSM) 

Clinical Data Integration Platforms

Electronic Clinical Outcome Assessment (eCOA)

Safety Solutions

Electronic Trial Master File (eTMF)

Electronic Consent (eConsent)

eClinical Solutions Delivery Mode Outlook (Revenue, USD Million, 2018 - 2030)

Web and Cloud based

On-premise

eClinical Solutions Development Phase Outlook (Revenue, USD Million, 2018 - 2030)

Phase I

Phase II

Phase III

Phase IV

eClinical Solutions End-use Outlook (Revenue, USD Million, 2018 - 2030)

Hospitals/Healthcare providers

CROs

Academic Institutes

Pharma & Biotech Organizations

Medical Device Manufacturers

eClinical Solutions Regional Outlook (Revenue, USD Million, 2018 - 2030)

North America

S.

Canada

Mexico

Europe

K.

Germany

France

Italy

Spain

Netherlands

Sweden

Denmark

Rest of Europe (EU) {RoE}

Asia Pacific

Japan

China

India

South Korea

Australia

New Zealand

Taiwan

Hong Kong

Singapore

Thailand

Vietnam

Rest of Asia Pacific (RoAPAC)

Central & South America

Brazil

Argentina

Chile

Rest of Latin America (RoLA)

Middle East & Africa

South Africa

Saudi Arabia

UAE

Egypt

Qatar

Rest of Middle East & Africa (RoMEA)

 List of Key Players in the eClinical Solutions Market

Fountayn, formerly known as Datatrak International, Inc.

Oracle

Calyx, formerly part of Parexel International Corporation

Medidata (Dassault Systemes)

CRF Health (Signant Health)

Clario (ERT and Bioclinica)

eClinicalWorks

Merative (IBM Watson Health)

Anju Software

eClinical Solutions

MaxisIT

IQVIA

Castor

Veeva Systems

Browse Full Report: https://www.grandviewresearch.com/industry-analysis/eclinical-solutions-market

[businesspointnews]

eClinical Solutions Market Report, Company Analysis, Business Challenges and Opportunitiese

IMARC Group has recently released a new research study titled “eClinical Solutions Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028”, offers a detailed analysis of the market drivers, segmentation, growth opportunities, trends and competitive landscape to understand the current and future market scenarios. How big is the eClinical solutions market? The…

[mysticalfungalaxy]

eClinical Solutions and Software Market is expected to reach a valuation of US$ 29.1 Billion by 2033 | FMI

The global eClinical Solutions and Software Market is anticipated to reach a valuation of US$ 29.1 billion in 2033, rising up from an estimated US$ 9.3 billion in 2023. Valued at US$ 8.4 billion in 2022, the market witnessed a CAGR of 10.6% from 2017 to 2022. It is gauged that the eClinical solutions and software market will expand at a stellar CAGR of 12.1% from 2023 to 2033. This growth can be attributed to the surge in funding for clinical research and life sciences will enable the widespread usage of eClinical solutions and software which, in turn, will promote the overall market growth during the forecast period.

Gain complete access to the report @ https://www.futuremarketinsights.com/reports/eclinical-solutions-and-software-market

The expansion of research and development activities by biopharmaceutical and pharmaceutical businesses will prompt the use of eClinical solutions and software in various clinical trials which will foster growth for the market. This is primarily due to the fact that in order to address certain contemporary eClinical trial management needs, many businesses will require a comprehensive eClinical platform that will adapt to required needs. Hence, the prospects for the eClinical solutions and software market look bright in the upcoming years.

With the surge in the amount of data produced via the clinical development process, the need for efficient tracking and evaluation of clinical data will also rise. As a result of this, the demand for eClinical solutions and software amplifies in clinical trials which, in turn, supplements the overall market growth. The eClinical solutions and software increase efficiency, lessen the expenditure, and errors like duplicate entry are avoided due to the use of eClinical technologies. This factor bodes well for the expansion of the eClinical solutions and software market size. Other factors that will aid the market growth are the progress witnessed in the life sciences field and the outsourcing of clinical trials to contract research organizations (CROs). All of these factors propel the Clinical Data Management Tools market forward during the projection period.

Key Takeaways:

High costs and constant maintenance expenditure will prevent the growth of the eClinical solutions and software market during the assessment period.

Based on the service, the clinical data management systems (CDMS) category will dominate the global market with an estimated share of 22.6% for 2023 and 2033.

By delivery mode, the web-hosted (on-demand) will lead the market with a share of 67.3%. 

The eClinical solutions and software market in the US will hold about 39.3% of the market share in 2023 due to increasing product launches by key players.

China’s eClinical solutions and software market will expand at a strong CAGR of 8.7% owing to greater medical needs.

Competitive Landscape 

Oracle

Datatrak International, Inc.

Dassault Systemes

CRF Health

eClinicalWorks

Parexel International Corporation

Bioclinica

eClinical Solutions

IBM Watson Health

Anju Life Sciences Software

ERT Clinical

Key Market Segments Covered in eClinical Solutions and Software Industry Research

Solution:

Randomization & Trial Management (RTSM)

Clinical Data Management System (CDSM)

Clinical Trial Management System (CLMS)

Electronic Clinical Outcome Assessment (eCOA)

Electronic Trial Master File (eTMF)

Electronic Data Capture

Others

Delivery Mode:

Licensed Enterprise (On-premise) Solution

Cloud-based (SAAS) Solution

Web-hosted (on-demand) Solution

Clinical Trial:

Phase I

Phase II

Phase III

Phase IV

End User:

Contract Research Organization

Medical Device Companies

Pharma/Biotech Companies

Hospitals & Clinics

Others

[prajwal-agale001]

eClinical Solutions: Driving Innovation in Clinical Trials and Data Management

Meticulous Research®, a leading global market research company, recently released an in-depth report titled, “eClinical Solutions Market Size, Share, Forecast, & Trends Analysis by Product (CDMS, CTMS, eCOA, ePRO, eDC, eTMF, Clinical Analytics, Safety Solutions), End User (Pharmaceutical, Clinical Research Organization, Medical Device), Phase – Global Forecast to 2031.” This report highlights the promising trajectory of the eClinical solutions market, projecting it to reach $23.32 billion by 2031, growing at a CAGR of 13.9% from 2024 to 2031.

Download Sample Report Here @ https://www.meticulousresearch.com/download-sample-report/cp_id=5910?utm_source=article&utm_medium=social&utm_campaign=product&utm_content=02-10-2024

Market Drivers

The growth of the eClinical solutions market can be attributed to several key factors:

1. Increasing Data Volume in Healthcare and Life Sciences

The healthcare and life sciences industries are generating massive amounts of data due to advancements in technology and the growing prevalence of electronic health records. This explosion of data necessitates robust solutions for management and analysis, driving demand for eClinical solutions.

2. Rising Number of Clinical Trials

As the need for new therapies and drugs increases, so does the number of clinical trials. The complexity and scale of these trials require efficient data management systems to ensure accurate results and compliance with regulatory requirements.

3. Supportive Initiatives for Clinical Research

Government initiatives aimed at promoting clinical research and development are also fueling market growth. These initiatives often include funding and regulatory support, which incentivize pharmaceutical and biotechnology companies to invest in eClinical solutions.

4. Growing Funding for Medical and Pharmaceutical R&D

With increasing investments in medical and pharmaceutical research and development, companies are more inclined to adopt advanced eClinical solutions to streamline their processes and enhance efficiency.

5. IT Infrastructure Strengthening Initiatives

Large hospital chains and clinical organizations are increasingly focusing on strengthening their IT infrastructure. This trend is creating demand for integrated eClinical solutions that can efficiently manage clinical trial data and processes.

6. Rising Demand for Precision Medicine

The move toward precision medicine, which tailors treatments to individual patient characteristics, is further driving the need for advanced eClinical solutions. These solutions facilitate the analysis of patient data and support the development of targeted therapies.

Key Players in the eClinical Solutions Market

The eClinical solutions market features several key players, including:

Dassault Systems S.E. (France)

Fountayn (U.S.)

Merative L.P. (U.S.)

eClinical Solutions LLC (U.S.)

Clario (U.S.)

eClinicalWorks, LLC (U.S.)

IQVIA Inc. (U.S.)

Parexel International (MA) Corporation (U.S.)

MaxisIT Inc. (U.S.)

Signant Health (U.S.)

Castor (U.S.)

Veeva Systems Inc. (U.S.)

Oracle Corporation (U.S.)

These companies are continually innovating to offer advanced eClinical solutions that address the evolving needs of clinical research and drug development.

Market Segmentation and Insights

The eClinical solutions market can be segmented by product, clinical trial phase, end user, and geography.

Product Segmentation

The market is categorized into several key product segments:

Clinical Data Management Systems (CDMS)

Clinical Trial Management Systems (CTMS)

Electronic Data Capture (EDC)

Electronic Clinical Outcome Assessments (eCOA)

Electronic Patient-Reported Outcomes (ePRO)

Clinical Analytics Platforms

Electronic Trial Master File (eTMF)

Safety Solutions

Other Product Types

Among these, the Clinical Trial Management Systems (CTMS) segment is projected to witness the highest growth rate of 13.5% during the forecast period. This growth can be attributed to the increasing complexity of clinical trials and the need for organized clinical trial data. CTMS plays a vital role in ensuring the quality, accuracy, and integrity of clinical data, which is crucial for evaluating the safety and efficacy of new drugs.

End User Segmentation

The eClinical solutions market is further segmented by end users, which include:

Pharmaceutical and Biopharmaceutical Companies

Clinical Research Organizations (CROs)

Medical Device Manufacturers

In 2024, pharmaceutical and biopharmaceutical companies are expected to dominate the market share. This is primarily due to the high volume of clinical trials conducted by these entities and their strong focus on accelerating drug research and securing approvals. For instance, in 2023, the U.S. Food and Drug Administration (FDA) approved 55 novel drugs, up from 37 in 2022, reflecting the industry's growing dynamism.

Clinical Trial Phase Segmentation

The eClinical solutions market can also be segmented by clinical trial phase:

Phase I

Phase II

Phase III

Phase IV

Each phase has distinct requirements and challenges, and eClinical solutions play a crucial role in addressing these needs.

Geographic Segmentation

The report provides a comprehensive analysis of the eClinical solutions market across several key regions:

North America (U.S. and Canada)

Europe (Germany, France, U.K., Italy, Spain, Switzerland, Sweden, Netherlands, and Rest of Europe)

Asia-Pacific (Japan, China, India, South Korea, Australia, and Rest of Asia-Pacific)

Latin America (Brazil, Mexico, and Rest of Latin America)

Middle East & Africa

North America

North America is currently the largest market for eClinical solutions, driven by factors such as a robust research infrastructure, the presence of key pharmaceutical companies, and increased awareness of the importance of data management in clinical trials.

Asia-Pacific

Asia-Pacific is projected to register the highest CAGR during the forecast period. Countries like India and China present lucrative opportunities for eClinical solution providers due to their rapidly growing pharmaceutical and biopharmaceutical sectors, a high number of clinical trials, and increasing investments in research and development. For instance, the Foreign Direct Investment (FDI) in India for drugs and pharmaceutical activities amounted to $1,344.1 million in 2021-22, highlighting the region's attractiveness for investment.

Future Outlook

The future of the eClinical solutions market appears promising, characterized by technological advancements and the continuous evolution of clinical research methodologies. The increasing complexity of clinical trials necessitates advanced data management solutions that can facilitate real-time monitoring, data integrity, and regulatory compliance.

Emerging Technologies

Several emerging technologies are likely to impact the eClinical solutions market:

Artificial Intelligence (AI) and Machine Learning (ML): These technologies can enhance data analytics capabilities, improve patient recruitment processes, and streamline trial management. AI-driven tools can analyze vast datasets to identify trends and predict outcomes, aiding in more efficient decision-making.

Blockchain Technology: As the need for data security and transparency increases, blockchain technology may play a crucial role in securing clinical trial data, ensuring that it remains tamper-proof and easily accessible to authorized stakeholders.

Decentralized Clinical Trials (DCTs): The shift towards decentralized trials is gaining momentum, offering greater patient convenience and enhancing participant diversity. eClinical solutions must adapt to support remote monitoring and data collection from participants in real-time.

Regulatory Changes

Regulatory agencies are increasingly emphasizing the importance of digital solutions in clinical trials. As guidelines evolve to accommodate new technologies, companies will need to stay abreast of these changes to ensure compliance and gain a competitive edge.

Focus on Patient-Centric Approaches

The future of clinical trials will likely focus more on patient-centric approaches, incorporating patient feedback into study design and implementation. eClinical solutions that facilitate real-time communication and data collection from patients will be pivotal in this transformation.

Conclusion

The eClinical solutions market is on a significant growth trajectory, driven by increasing data demands, the proliferation of clinical trials, and supportive government initiatives. With key players investing in innovative technologies and strategies to enhance their offerings, the market is poised for substantial expansion in the coming years. Companies that leverage advanced eClinical solutions will be better equipped to navigate the complexities of clinical research, ultimately contributing to faster drug development and improved patient outcomes.

As we look ahead, the integration of emerging technologies, the focus on patient-centric approaches, and the evolving regulatory landscape will play crucial roles in shaping the future of the eClinical solutions market. Stakeholders across the healthcare and life sciences industries must remain agile and proactive in adapting to these changes to harness the full potential of eClinical solutions.

Read Full Report :- https://www.meticulousresearch.com/product/eclinical-solutions-market-5910

Contact Us: Meticulous Research® Email- sales@meticulousresearch.com Contact Sales- +1-646-781-8004 Connect with us on LinkedIn- https://www.linkedin.com/company/meticulous-research

[market-insider]

Eclinical Solutions Rising Demand Attributed To Increasing Tracking And Analyzing Clinical Data

The global eClinical solutions market size is expected to reach USD 21.8 billion by 2030, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 13.9% from 2023 to 2030. Increasing R&D activities by biopharma and pharma companies, application of software solutions in clinical trials, and expanding customer base are anticipated to fuel market growth. During the COVID-19 pandemic, clinical laboratories experienced high demand for COVID-19 tests. eClinical solutions, such as the clinical data management systems assisted these laboratories to seamlessly manage the huge influx of specimens daily. Technological advancements such as electronic data capture and Wi-Fi connectivity are projected to drive the market in the forthcoming years.

Gain deeper insights on the market and receive your free copy with TOC now @: eClinical Solutions Market Report

As the demand for tracking and analyzing clinical data increases, the need for effective clinical solutions rises. Unmet needs to manage efficient clinical development processes are poised to boost market growth over the forecast period. Moreover, digital transformation in the field of clinical trials and preference for data-centric approaches are providing a tremendous push to the market. Demand for integrated clinical IT solutions is increasing due to the massive volume of data generated during clinical development processes. eClinical solutions offer a single source of information that helps optimize the cost by eliminating redundant data entry and by reducing on-site verification and source data verification. Rising awareness regarding these advantages is projected to propel the market. Increasing adoption of eClinical workflows in trials offers enormous potential in clinical development processes. These solutions can facilitate decision-making in each stage of development. It also helps reduce cost and time between the development phase by utilizing seamless designs and by identifying failing compounds. In addition, it offers rapid access to data and patient safety information, which helps make quick decisions. Market players engage in new product development and strategic alliances including partnership agreements, promotional activities, and acquisitions to keep market rivalry high. For instance, in October 2020, Oracle entered into collaboration with FHI Clinical Inc. for improving clinical trial efficiency and to get therapies to market faster.

[medicaldevicesindustrynews]

The Short but Complete Guide About eClinical Solution

The Short but Complete Guide About eClinical Solution

Software and technologies called eClinical solutions are used to efficiently manage clinical research and clinical trials. The numerous programs provided under the aid of the eClinical solution in a variety of tasks, including organizing, updating, and gathering data as well as keeping track of deadlines. A few examples of several eClinical systems are the clinical trial management system…

[jeeva-trials]

Empowering Sponsors with Compliant Data Collection and Integrity for a Variety of Clinical Studies | Jeeva Trials

Traditional clinical guidelines, and stand-alone patient study and care pathways are proven to be increasingly inadequate, especially in a post-pandemic world with low clinical adherence, disrupted workflows, and stay-at-home orders. Disrupted workflows means more time required to complete a study, fatigue of the research team, and wastage of resources.

Researchers and study teams are increasingly adopting eClinical cloud trial tools that are designed to augment researchers, study teams and clinicians to augment their complex decision-making processes with targeted clinical knowledge, patient information and computerized clinical workflows. It directly improves the quality of clinical documentation. AI technologies provide the tool capabilities for drawing insights into data beyond what humans can. CROs (Contract Research Organizations) evaluate clinical study tools largely based on speed, flexibility and cost-efficiency. However, amidst these concerns, data integrity is not to be understated or taken for granted. Data integrity is not only important for a study, it needs to be addressed throughout the product life cycle across Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and other Good Practice (GxP) areas.

Data integrity is critical for studies

Good risk mitigation and management is essential to data integrity as multiple points of risk exist throughout data recording, storage, transfer, reporting and other stages of data lifecycle during a study trial. It is achieved by making data traceable throughout audit trails. Transparency is demonstrated with a chain of custody from data origin to its analysis. Without data integrity, it is not possible to regenerate a previous clinical trial result reliably. Data integrity cannot be validated by point-to-point interfaces of individual systems alone, it requires a more holistic approach towards validation and quality management as these systems need to work together across corporate borders and multi-site systems.

Quality of data can affect the quality of decision support because if data collection is not standardized, the study trial data is effectively corrupted and increases the risk of failure during the submission procedure for approval by Food and Drug Administration (FDA), Medicines and Healthcare Products Regulatory Agency (MHRA) and other regulators. Regulators in the US and across the world continue to stress the criticality of data integrity in clinical trials.

Points to consider while choosing an eClinical study solution:

A good system should not delete or obscure previously-recorded audit trail information and prevent modification by the user.

It should record complete audit trail records including identification of the data element that was changed, who authorized the change and implemented them.

It should provide early visibility to reliable data to quickly make sound decisions and bring life-enhancing treatments to life.

Cyber security is a mission-critical consideration for electronic clinical outcomes assessment (eCOA) risk management for any eClinical solution.

Regulatory-minded study teams will have data integrity plans in place as regulators can raise questions about data collection compliance, warranting rescue action. By utilizing the Jeeva Informatics eClinical cloud, study teams can have regulation-compliant risk mitigation with complete transparency, traceability, and documentation. Jeeva is a flexible bring your own device (BYOD), SaaS (Software as a Service) solution that is designed to maintain data integrity with features and protocols that fit the specific trial protocol, ensuring reliability and authenticity of the study data by adhering to the most current compliance regulations in force.

Shortening the Distance from Study Data to Action

Jeeva’s highly scalable SaaS architecture provides a cost-effective approach to support trials for multiple studies, phases and therapeutic areas. Its intuitive interface eliminates the multi-step process to navigate reports and shortens the distance from study data to action. In clinical research, data integrity and reliability of trial results are paramount. The value of a comprehensive and compliant eClinical tool is absolute. Data integrity continues to be a major theme across inspection results. The collaborative technology used in Jeeva automates high-value clinical trials recruitment and retention tasks and provides insightful retrieval of information. Adherence to the International Council on Harmonization (ICH) GCP is a core tenet for data integrity at Jeeva.

Leading research organizations have consistently been using Jeeva for compliant and adaptive research with access to immediately actionable patient data. It provides researchers personalized clinical study documentation across solutions, platforms and devices, anytime and anywhere, regardless of physical location.

Enabling Clinical Research at Scale

A failed trial not only sinks investment into the early stages of the trial itself but also results in dissatisfied sponsor clients and impacts your long and fruitful business relationship with them. Jeeva is designed to support the conduct of clinical trials utilizing validated functionality and processes. The modular software enables clinical research at scale and saves more than 70% time and logistic burden on the study teams. Utilizing the platform-agnostic software with advanced features like bi-directional communications, scheduling and touch-less electronic informed consent, investigators can rapidly enroll participants in the study, and investigators can safely review the study material remotely and conveniently from their own mobile device.

Complying with the Current Regulations

Jeeva Trials follows a human-centric approach with a deep understanding of the perspectives and requirements of various stakeholders including regulatory compliance specialists, IT security and privacy professionals, auditors and coordinators. The burden of ensuring regulatory compliance of technology solutions, GDPR (General Data Protection Regulation), Institutional Review Boards (IRBs), human subjects protection guidelines, GCP (Good Clinical Practice) guidelines by ICH (International Council of Harmonization) of Technical Requirements for Pharmaceuticals for Human use, and other regional guidelines lies with the study sponsor. Jeeva adheres to the current federal, state, and international regulations or guidelines for conducting clinical trials using electronic patient data such as the FDA 21 CFR (Code of Federal Regulations) Part 11, SOC 2 (System Organ Classes), Amazon Well (AWS) Architected Framework Review, AWS Foundational Technical Review, GDPR privacy policies, and others. Avoid having to validate multiple a la carte tools as you can now achieve the same goal with a single all-in-one integrated SaaS platform.

Saving on Costs of Failed Trials

It takes on average 10-15 years and USD 1.5-2.0 billion to bring a new drug to the market. Approximately half of this expenditure covers testing, preclinical compound discovery and regulatory processes. The high failure rate of clinical trials due to regulatory issues, patient non-adherence, low retention and high drop-offs during long-term studies is a major stumbling block in drug development. Less than one-third of all Phase II compounds advance to Phase III, with more than one third of all Phase III compounds failing to advance to approval. The most complex Phase III trials carry nearly 60% of the overall trial costs, resulting loss per failed clinical trial to the order of 0.8-1.4 billion USD.

Flexible Platform to Accelerate Patient Recruitment

Study build delays cause timelines to drag on, as such CROs face not only dissatisfied sponsor clients but they could lose a fruitful business relationship. There are major regulatory implications as well, as unverified, disintegrated and dubious data quality can land organizations in court. Jeeva Informatics Solutions is designed to reduce timelines for study startup and participants by up to more than 50%, while complying with data integrity regulations of the federal and state governments. Jeeva makes it easy for longitudinal cohort studies to collect validated data from participants in real-world settings over extended periods of time. The flexible platform accelerates patient recruitment and retention, and enables long-term engagement for 5, 10, or 15-year follow-up studies for long-term trials, such as cell and gene therapy.

Affordable subscription-based pricing of Jeeva makes it easier for the study teams to plan budgets with predictable expenses. The modular SaaS subscription model helps clinical researchers, Contract Research Organizations (CROs), and sponsors manage a clinical study’s annual budget on a simple, per participant basis.