#clinical trials software

[jeeva-trials]

Dealing with challenges in Quality Evidence Generation with a Real-Time Analytical Framework that makes Clinical Sense for Innovators

Evidence linking interventions with health outcomes is vital for healthcare decision-making. Making sound choices about healthcare requires the best possible and quality evidence from clinical research. However, some of the decisions currently made during the drug development process are not supported by high-quality evidence.  As such, making informed decisions for allocating adequate resources to guide clinical Research development becomes challenging. At mid-stage clinical development, the challenge entails in determining the specific indication, if there are multiple potential indications. Moreover, evidence that is complete for some individuals or groups may be incomplete for others, leading to inefficiencies in decision-making.

Evidence generation strategies are especially important at Phase III and Phase IV trials to allow for effective navigation through competitive and regulatory hurdles, while it may be difficult to effectively communicate potentially attractive product attributes to the stakeholders, especially when it has no clear advantage over comparators. Stakeholders also lack the evidence needed to make real-world decisions on approval, coverage and use of treatments as most current processes used in evidence generation focus narrowly on the safety and efficacy of treatment.

Datasets to inform real-time decision making

The traditional demarcation between pre- and post-approval phases does not fit many medical products, as regulatory decisions could be informed by the same evidence that informs the use and coverage decisions, though the criteria for decisions should not be the same for both cases. Validated tools, based on large datasets to help inform real-time decision making are invaluable, yet they are currently limited. When new treatments are approved, healthcare payers and those who participate in shared savings base coverage determination on their value which is calculated by the evidence of benefit and net costs. The incorporation of real-world data (RWD) and patient-reported outcomes (PRO) into the evidence generation process could assist in making coverage determinations by rendering clinical evidence and research more immediately translatable to the beneficiary population.

Real-world data (RWD) and real-world evidence (RWE)

Additionally, large differences usually exist between the evidence required for initial adopters, such as surveys and studies, and that required for most prospective randomized control trials (RCTs). While the healthcare community uses RWD and RWE to develop decision support tools for use in clinical practices, medical product developers use these data to support clinical trial designs and observational studies to generate innovative treatment approaches. FDA uses RWE and RWD to monitor adverse events, post-market safety of the drug, and to make regulatory decisions. While RWD can be collected from various sources such as electronic health records (EHRs) and product and disease registries, RWE can be generated by different study designs including observational studies and randomized trials.  

Aligning stakeholders for evidence generation

Aligning stakeholders is another big challenge of evidence generation as different stakeholders will have their own perspectives on uncertainties throughout the drug development lifecycle. Regulators may have different views as to what is acceptable to that of the patient. As such, it remains an industry-wide challenge to provide credible evidence for clinical research to innovators and investigators. Challenges exist for healthcare innovators to keep up to date with compliance and regulations about evidence generation as regulatory space evolves fast.

Because pharmaceutical companies tend to delegate evidence generation to individual departments that are often siloes, the process occurs sequentially, resulting in delays in crucial milestones such as getting regulatory approval before initiating an outcomes-based study.

https://www.futuremedicine.com/doi/10.2217/cer-2017-0073

An analytical framework model that makes clinical sense

There is a pressing need for high-quality evidence generation as regulators and payers seek more long-term data on product safety and effectiveness. As such, more efficient methodologies for generating evidence are required for decision-making, and to enhance clinical evidence collection and interpretation. An analytical framework model makes clinical sense as an evidentiary pathway, however, the challenge for investigators in evidence gathering is to fill out the framework. If the study design is weak, then the link in the evidence chain is also weak. Studies need to be carefully and prospectively designed, and opportunities exist to add well-designed studies into current practices. Study teams and researchers should consider how to most effectively translate diagnostic tests into practice needs within clinical settings.

Quality clinical evidence of safety and efficacy

The Jeeva™ eClinical Cloud platform provides clinical decision-makers with a modular and integrated approach to evidence planning and generation. From a single dashboard, study leaders can monitor data in real time to track safety and efficacy in representative patient populations across vast distances. The Jeeva™ eClinical Cloud is designed for efficient, remote long-term follow-up, natural history and other observational studies as well as interventional clinical trials regardless of therapeutic area. Jeeva™ enables quality clinical evidence generation to evaluate treatment safety and efficacy and tracks patients’ adherence to medications, in compliance with regulatory agencies such as Institutional Review Boards, EMA, FDA, and GDPR.

Digital-first approach to evidence generation

Study teams, innovators, drug developers, biopharmaceutical sponsors, clinical researchers, hospital sites and contract research organizations (CROs) face challenges to overcome the “no evidence, no implementation—no implementation, no evidence” paradox. Jeeva™ provides a new, digital-first, patient-centric approach to evidence generation that considers patients as partners for clinical trials, not merely subjects.  

The Jeeva™ eClinical Cloud is user-designed software-as-a-service (SaaS) platform that allows volunteers to conveniently complete clinical trials wherever they are. The flexible and modular bring-your-own-device (BYOD) solution works on any browser-enabled mobile device and cuts out 70% of logistical burdens for study teams and patients. The modular and flexible Software as a Service (SaaS) subscription-based model is enriched with many features such as automated enrollment workflows, electronic patient-reported outcomes, 2-way email and SMS communication, uploading of lab reports, and more that are designed to encourage innovators to undertake research activities, rather than be intimidated by the complexity, logistical burdens, duration and costs of the traditional evidence generation approaches.

Quickly setup clinical studies of any scale or duration

Jeeva™ applies an innovative approach to remote screening, eConsent, patient registries and natural history studies can enable the generation of higher-quality, low-cost and more timely evidence generation for clinical trials. Jeeva™ offers a cost-effective solution to quickly set up and conduct clinical studies, of any scale or duration, with or without patient travel involved (e.g. hybrid or fully decentralized clinical trial protocols). Jeeva™ provides a more effective clinical trial design in terms of evidence generation, accelerating patient recruitment, site feasibility and endpoints that bring unmatched efficiencies in terms of the quality of evidence, time, and costs.

[rootsanalysis-blog]

The clinical trials software market is projected to be growing at a CAGR of 14%

Given the limitations of current clinical trial approaches, including inefficient patient management and data handling, trial sponsors are increasingly opting for innovative technologies and software solutions for conducting clinical trials

 Roots Analysis has announced the addition of “Clinical Trials Software Market, 2022-2035” report to its list of offerings.

 Excessive capital expenditure and other complexities associated with the traditional clinical trials has imposed an enormous financial burden on the pharmaceutical industry. Virtual clinical trials software solutions have the potential to induce substantial digital changes in clinical research methodology, resulting in a more patient-centric, cost-effective and easy to manage approach.

 To order this 270+ page report, which features 60+ figures and 50+ tables, please visit https://www.rootsanalysis.com/reports/clinical-trial-software-market.html

 Key Market Insights

 Over 70+ companies claim to provide clinical trials software

The companies offer clinical trials software with different features like electronic data capture, eCOA/ePRO and eConsent along with decentralized and virtual clinical trials and remote monitoring of the patients. Majority of the players based in North America offer clinical trials software followed by Europe and Asia-Pacific. Further, the market is dominated by the presence of mid-sized players (more than 40%) followed by small and large players.

 Clinical trial management software

It is a well-known fact that clinical trials form an integral part of the overall drug development process, enabling innovators to assess safety and efficacy of their drug candidates / devices. These studies account for around 50% of the total time and capital invested in the development process

Since 2016, more than 120+ partnerships have been inked by service providers

Interestingly, the maximum number of partnership agreements were inked in 2021, majority of these were service agreements (44%), followed by acquisitions/mergers (26%). Further, most of the deals were inked with players based in North America (64%).

 Over 30 mergers and acquisitions were reported in this domain, during the period 2016-2021

More than 85% of these were instances of acquisitions. Further, majority of the instances involved the companies based in North America and the maximum number of deals were inked in 2019.

 Over USD 492.8 million has been invested by both private and public investors, since 2016

Majority of the companies (67%) engaged in this domain primarily received funding through venture capital rounds. Further, around 98% of the funding instances were reported by players headquartered in North America.

 The market is expected to grow at an annual rate close to 14% over the coming decade

The opportunity is likely to be well distributed across clinical trials software on the basis of features of software (EDC, eCOA/ePRO and eConsent) and geographies (North America, Europe and Asia-Pacific). By 2035, the clinical trials software market in North America is anticipated to grow at a relatively faster pace (39%), followed by the market in Europe (21%).

 Clinical trial management system : Driven by the substantial progress in this domain, encouraging virtual clinical trial results, and ongoing technological advancement, the clinical trials software market is anticipated to grow at a commendable pace in the mid to long term.

 To request a sample copy / brochure of this report, please visit https://www.rootsanalysis.com/reports/clinical-trial-software-market/request-sample.html

  Key Questions Answered

 §  Who are the leading players engaged in the development of clinical trials software solutions?

§  Which region(s) will occupy the maximum market share in clinical trials software domain?

§  Who are the key venture capitalists / strategic investors funding the clinical trials software development initiatives?

§  Which partnership models are commonly adopted by stakeholders engaged in the development of clinical trials software solutions?

§  Which factors are likely to influence the evolution of this market?

§  How is the current and future market opportunity likely to be distributed across key market segments?

 By 2035, the financial opportunity within the clinical trials software market has been analysed across the following segments:

§  Features of Software

§  Electronic Data Capture

§  eCOA/ePRO

§  eConsent

 §  Analysis by Geographical Regions

North America

Europe

Asia Pacific

 The research includes profiles of key players (listed below); each profile features a tabulated overview of company, product portfolio, recent developments, and an informed future outlook.

§  Advarra

§  ArisGlobal

§  AssistRx

§  Clario

§  IBM

§  IQVIA

 For additional details, please visit

https://www.rootsanalysis.com/reports/clinical-trial-software-market.html or email sales@rootsanalysis.com

 You may also be interested in the following titles:

1.     Virtual Clinical Trial Service Providers Market, 2021-2030

2.     AI-based Clinical Trial Solutions Providers Market, 2020-2030

3.     Patient Recruitment and Retention Services Market (2nd Edition), 2021-2030

4.     Virtual Clinical Trial Service Providers Market, 2020-2050

 About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

  Contact:

Ben Johnson

+1 (415) 800 3415

+44 (122) 391 1091

Ben.johnson@rootsanalysis.com

[transcriptioncity]

What is Linguistic Validation?

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[dacimasoftware]

Unlocking Efficiency: The Power of RTSM Software in Clinical Trials

Randomized Trial Supply Management (RTSM) software revolutionizes the management of clinical trial supplies, enhancing efficiency and ensuring the smooth progress of research endeavors. By automating inventory management, randomization, and drug dispensation processes, RTSM software minimizes errors and streamlines operations, saving valuable time and resources.

One of the key benefits of RTSM software is its ability to adapt to the dynamic nature of clinical trials. With features like real-time data tracking and forecasting, researchers can anticipate supply needs, mitigate risks of stockouts, and maintain adequate inventory levels throughout the trial duration. This proactive approach prevents disruptions, reduces costs, and accelerates trial timelines.

Moreover, RTSM software enables seamless integration with other clinical trial management systems, fostering collaboration among stakeholders and facilitating data exchange. This interoperability enhances visibility into trial operations, promotes transparency, and supports informed decision-making at every stage.

Furthermore, RTSM software enhances compliance with regulatory requirements by ensuring accurate documentation and audit trails. By maintaining comprehensive records of drug allocation and distribution, researchers can demonstrate protocol adherence and regulatory compliance, safeguarding the integrity and validity of trial results.

In essence, RTSM software represents a paradigm shift in clinical trial supply management, empowering researchers to navigate the complexities of trial logistics with precision and confidence. Its robust capabilities drive operational efficiencies, reduce risks, and ultimately contribute to the advancement of medical science.

[samichinam]

https://samichinam.in/samwed

The Samwed ™ platform aids an organisation, accumulate its knowledge across all of its functions, developing its quality conciseness. Samwed is a Sanskrit term made up of the words Weda (veda), which denotes knowledge, and the prefix Sam, which is used to indicate oneness. Perception is another meaning of the word Samwed. In reality someone is perceived based on how others appraise someone's knowledge.

The US-FDA and other similar regulatory agencies are keen upon Quality by Design (QbD). The fundamental idea behind this notion is that quality should be built into a product via knowledge about the product, the method by which it is generated, and risk analysis and mitigations for manufacturing. In other words, it is necessary to continually build up knowledge of the product and the process in order to produce better insights and use those insights to raise the quality.

[agmatix]

Streamline Trials with Agmatix's Trial Management Software

Discover the power of Agmatix's trial management software for seamless trial coordination and oversight. Our user-friendly platform is designed to streamline trial processes, from recruitment to data analysis.

With Agmatix's intuitive trial management software, researchers can easily track participant progress, manage study protocols, and analyze results in real-time. Say goodbye to manual tasks and inefficiencies – Agmatix automates repetitive processes, saving time and resources.

Experience the difference with Agmatix's trial management software. Explore our solutions today and revolutionize your clinical trials.

[octalsoft]

Does Your Electronic Data Capture (EDC) System Provide Enough Flexibility

According to the Tufts Centre for the Study of Drug Development (Tufts CSDD) study, at least one protocol change happens in more than half of all clinical trials. These changes have the potential to destabilize locations and research teams, causing inefficiencies. For example, if a change affects how therapy is administered or how and what data is collected, sites may need to re-consent with a patient. Changes in research procedures cause big logistical issues for everyone involved and waste a lot of time, especially when it comes to clinical trial data gathering.

Modern EDC Systems Must Accommodate Protocol Amendments

Data collection and patient visit schedules are disrupted if a protocol amendment necessitates. According to the Tufts CSDD research, clinical trials average 2.2 to 2.3 protocol revisions. This means that electronic data capture in clinical trials may have to be shut down several times, which is both disruptive and wasteful. Given the frequency with which changes occur, EDC systems should be built to sustain regular operations while adapting to changes.

Amendments that codify clinical trial data gathering, on the other hand, must be explicitly indicated for users to ensure that each modification is implemented throughout the study. If a new field is introduced to a form, the user interface should make it apparent that the new field must be filled out. Otherwise, clinical research coordinators may overlook the addition of a new item to their process. These sorts of notifications are straightforward but useful procedures that should be common in EDC systems. A clear approach for training or retraining users on any new feature should be included as part of that infrastructure.

Adaptable Designs, Adaptable EDC

Clinical trial design is becoming increasingly difficult. Adaptive trials, for example, evolve over time, which means that an EDC system must account for every conceivable path the trial may take. There are also several types of trials, such as basket, umbrella, and platform, each of which need a versatile electronic data capture software for clinical trials. As sponsors employ a broader range of complicated clinical trial designs, their EDC systems must be capable of implementing complex changes—often in the middle of a study.

Telehealth consultations quickly became a viable and essential alternative to in-person sessions during the COVID-19 epidemic. Remote visits in clinical trials increased in 2020 and 2021 as a result of site closures, travel limitations, and patients' reluctance to attend a medical center. Data from telemedicine platforms, wearables, sensors, and other sources must be integrated into EDC systems for this decentralized research. They also need the capability and flexibility to support numerous treatment arms as well as the mid-study adjustments that are inherent in adaptive trial designs.

Octalsoft EDC Supports the Next Era of Clinical Data Management

Octalsoft is constantly improving electronic data capture systems to match the flexibility demands of current clinical trials. EDC does not need any downtime for protocol changes. Following implementation, site users are automatically allocated the tasks necessary to accommodate the change, and revised eCRF completion criteria may be published and made instantly accessible, informing site users about the eCRF modifications and what new/changed data are required. Once a modification is made, it may be implemented without disrupting patient site appointments or bringing the entire system down. The ultimate goal: consistent, uninterrupted performance.

For reporting reasons, effective electronic data capture solutions log all modifications so users know when and how they were applied. modifies can also be reversed if, for example, a patient withdraws consent following a protocol modification that modifies what data they must supply. EDC saves users time by automating as many of these procedures as possible, allowing them to focus more on patients and the day-to-day operations of clinical trials.

Although all aspects of a clinical trial are rigorously monitored, studies are becoming increasingly complicated, protocol changes are regular, and recruitment is unpredictable. Furthermore, our environment is continually and rapidly changing, which has a direct influence on both trials and participants. 

There are three core reasons why Octalsoft EDC is a firm favorite for clinical data management, clinical operations, and clinical database programming teams:

1. High Configurability

The majority of EDC studies may be built without the use of special functions. A study's components may be customized in 95% of cases. Octalsoft and our clients both have libraries of reusable custom functions to help them construct new studies faster. Customers can employ EDC's Professional Services team or create their own sophisticated research. Other solutions may need the development of additional functionality by a vendor in order to support a certain protocol.  

2. Flexibility

EDC enables the ability to personalize the study construct and execute any protocol amendment or other mid-study design modification to provide support for any protocol, including complex adaptive designs and master protocols.

3. Transformational Study Build Processes

Octalsoft is dedicated to streamlining operations while maintaining quality and efficacy. By allowing greater study-build customization through the user interface, our next-generation study design technology changes the process. This novel method incorporates complicated casebook dynamic behavior. Because clinical data capture is no longer limited to EDC, we're centralizing the definition of a study across applications, including developing data source agnostic edit checks and data definitions (i.e., the same data definitions and edit checks would apply whether collected via EDC or eCOA).

Many of the edit checks we write now (to account for all eventualities) never run. A recent study at a big pharma customer revealed that anywhere from 45% to 75% of scheduled edit checks were never completed.

Octalsoft is enabling a more intelligent, risk-based approach to building research. As part of our next-generation data platform that supports the progression of clinical data management to clinical data science, we maintain data quality by concentrating edit check development on the most prevalent cases and employing AI/ML to detect data abnormalities. As a result, the amount of custom programming necessary to implement research will be reduced. 

These three fundamental elements result in simplified study builds, which speed up the study construction procedure for many clinical studies.

Conclusion

To meet the clinical trial landscape's complexity and unpredictability, the only logical technology solution is a system with the functionality, adaptability, and flexibility to properly fit with your research. This necessitates the use of a system that is adaptable, can use pre-existing custom functions, and can create new custom functions to meet specific needs. If your EDC lacks them, it will be unable to expand and accommodate the rising number of complex/innovative trials.

This adaptability is one of the primary reasons Octalsoft's EDC has been chosen by over 30,000 users.

Octalsoft's staff collaborates with you to understand your study objectives, study design, and any special requirements. Alternatively, our training experts will assist you in creating your own studies. 

Want to know more about how Octalsoft can help boost the flexibility and modularity of your next clinical trial? Book a demo with us today.

[soumyafwr]

https://www.shtfsocial.com/blogs/131608/Clinical-Trials-Matching-Software-Market-Overview-Competitive-Analysis-and-Forecast

Clinical Trials Matching Software Market Overview, Competitive Analysis and Forecast 2031

[neolytica]

Neolytica - Transforming HCP Segmentation, Engagement, and Targeting

Discover the power of Neolytica's innovative software solutions for HCP Segmentation, Engagement, and Targeting. Unleash the potential of KOL Mapping, Health Care Mapping, and Patient Recruitment for clinical trials. Revolutionize your healthcare marketing strategy today.

[purnima05]

Why is a Clinical Trial Management System Essential for Success?

Clinical trials are fundamental in advancing healthcare and bringing new treatments to patients. Effective management of these trials is crucial for success. Clinical Trial Management streamlines this process, enhancing efficiency and aiding in better decision-making. 

Understanding the Clinical Trial Management System (CTMS)

Clinical Trial Management System, often abbreviated as CTMS, is a centralized software solution designed to streamline and manage every aspect of clinical trials. From planning and tracking to reporting and analyzing, a CTMS system is a comprehensive tool used by researchers, sponsors, and stakeholders to ensure the smooth execution of clinical trials.

The Key Components of a CTMS System

Trial Planning and Design: Creating a blueprint for the trial, including protocols, endpoints, and participant criteria.

Subject Management: Managing participant information, recruitment, and enrollment into the trials.

Document Management: Organizing and storing trial-related documents and essential paperwork.

Data Collection and Analysis: Collecting, organizing, and analyzing trial data to derive meaningful insights.

Budget and Financial Management: Monitoring and controlling trial-related expenses and budgets.

Advantages of Implementing a Clinical Trial Management System

Efficient Data Management: Streamlining data collection, reducing errors, and enabling real-time access to data for all stakeholders.

Enhanced Compliance and Regulatory Adherence: Assisting in maintaining compliance with regulatory standards and guidelines throughout the trial.

Improved Communication and Collaboration: Facilitating seamless communication among trial stakeholders, promoting collaboration and efficiency.

Cost and Time Efficiency: Optimizing clinical trial software solutions processes, resulting in cost savings and faster development of treatments.

The Evolving Landscape of Clinical Trial Management Clinical trial management has come a long way from paper-based systems to advanced CTMS solutions. These systems now integrate features like Artificial Intelligence (AI) and Machine Learning (ML) to predict outcomes, optimize resource allocation, and enhance decision-making.

Emerging Trends in Clinical Trial Management

Decentralized Clinical Trials: Leveraging technology for remote monitoring and data collection, minimizing the need for physical site visits. Patient-Centric Approach: Placing more emphasis on patient experience and involvement in the trial process. Real-world Evidence Integration: Incorporating real-world data to complement traditional clinical trial data, providing a more comprehensive understanding of treatment outcomes.

How To Choose the Right Clinical Trial Management Software?

When selecting clinical trial software, organizations should consider factors such as ease of use, scalability, integration capabilities, compliance with industry standards, and the specific needs of their trials.

Conclusion:

The Evolving Landscape of Clinical Trial Management

Clinical trial management has come a long way from paper-based systems to advanced CTMS solutions. These systems now integrate features like Artificial Intelligence (AI) and Machine Learning (ML) to predict outcomes, optimize resource allocation, and enhance decision-making.

Emerging Trends in Clinical Trial Management

Decentralized Clinical Trials: Leveraging technology for remote monitoring and data collection, minimizing the need for physical site visits.

Patient-Centric Approach: Placing more emphasis on patient experience and involvement in the trial process.

Real-world Evidence Integration: Incorporating real-world data to complement traditional clinical trial data, providing a more comprehensive understanding of treatment outcomes.

How To Choose the Right Clinical Trial Management Software?

When selecting clinical trial software, organizations should consider factors such as ease of use, scalability, integration capabilities, compliance with industry standards, and the specific needs of their trials.

Conclusion:

Clinical Trial Management Systems are transforming the landscape of healthcare trials. By streamlining processes, enhancing collaboration, and leveraging cutting-edge technologies, clinical trial management software plays a pivotal role in expediting the development and approval of life-changing treatments.

[jeeva-trials]

Logo - Jeeva Informatics

The Human-Centric eClinical Platform. Fast. Flexible. Simple.

[marketreports-blog]

The global clinical trials matching software market size was exhibited at USD 149.6 million in 2022 and is projected to hit around USD 521.47 million by 2032, growing at a CAGR of 13.3% during the forecast period 2023 to 2032.

[root-analysis]

Growth Potential and Insights in the Clinical Trial Software Market

The Roots Analysis report is a comprehensive study that examines the current market landscape and future opportunities for those involved in clinical trial software. The study provides a detailed analysis, focusing on the capabilities of different stakeholders in this field.One of the key objectives of the report was to estimate the future growth potential of the clinical trial software market. To obtain a detailed insights report, please click here.

[bleap23]

Clinical Trial Management System (CTMS) – Best Clinical Trial Software

"All rules pertaining to security, access control, change control, audit trails, and system validation are adhered to by the Clinevo Clinical Trial Management System (CTMS). the top clinical trial software available right now. Our Clinical Trial Management System (ctms) offers thorough clinical trial planning and management at all stages of medical and non-medical operations. The system, which includes more than 100 clinical trial administration methods, is comprehensive, modern, and useful."