Life Science E-Clinical Systems Reviews and Ratings
What are Life Science E-Clinical Systems?
Gartner defines e-clinical systems as software solutions or platforms that facilitate clinical trials by supporting study setup, conduct, and analysis. The clinical trial process begins with a protocol outlining trial methodology and ends with results and conclusions in a clinical study report. E-clinical systems streamline this process by collecting, cleaning, and interpreting trial data, and supporting site monitoring, biostatistics, and clinical supply management. These systems enable life science organizations to optimize and scale clinical trials globally, transforming them from labor-intensive, paper-based processes to efficient digital ones.
E-clinical systems accommodate trials ranging from Phase 1 at a single site with hundreds of volunteers to Phase 3 with hundreds of sites and thousands of participants. While stand-alone solutions exist, e-clinical systems are typically deployed as global, multitenant platforms that integrate solutions across clinical trial operations. They manage and support trials by integrating multiple solutions, beginning with building the study application in an electronic data capture (EDC) environment. This setup allows for clinical management, supply management, and data entry. As trials progress, sites are added, and data is entered by site personnel during participant visits. The data is then reviewed, cleaned, and the database locked to prevent further changes.
E-clinical systems support both content and data flow, characterized by solutions for key business areas involved in trial execution. These include EDC for data management, a clinical trial management system (CTMS) for trial operations, and a statistical compute environment (SCE) for biostatistics. Despite advancements, the process remains partly digital, with significant potential for improvement by converting paper-based processes into digital and mobile-based solutions, ultimately leading to fully digital trials.
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Medidata bridges the gap in the clinical research domain by being at the forefront of the digital revolution. Its key focus is to leverage AI to unearth valuable insights from patient-centric clinical trials, serving as a useful resource to organizations involved in biological technology, pharmaceuticals, diagnostics, and medical device industry, as well as academic researchers. Medidata's innovative approach aims to accelerate value, de-risk processes, and enrich outcomes. As a distinguished contributor to life sciences' technology, Medidata handles a significant volume of trials and participants, providing insights to a broad spectrum of users from diverse backgrounds, all working with the common goal of developing better clinical strategies and enhancing public health. Headquartered in New York City with a global presence, Medidata is a Dassault Systèmes company.
Caidya is a global clinical research organization (CRO) that offers a comprehensive range of clinical services to innovators worldwide. The company's main focus is on providing excellence in service delivery and enhancing the user experience. Caidya's services extend from pre-IND strategy to clinical development, submission, and post-marketing surveillance. Possessing extensive therapeutic knowledge, the company utilizes cutting-edge clinical technology for transparent trial processes and data-backed decision making. Founded in 2021 as a result of a merger between two CROs, the company currently employs nearly 1,800 people in over 30 countries globally.
Fortress Medical Systems, founded in 1997, developed Clindex, an innovative integrated solution for clinical trials initially designed for medical device studies. Over time, Clindex broadened its use to a wider range of studies including pharmaceutical and diagnostic trials, plus combination product research thanks to additional features. The market acknowledges Clindex for its flexibility and comprehensive service, suitable for an international user base. Clindex is extensively used in various studies supporting FDA applications. The software is globally deployed with a widespread user base. Clindex has been audited by the FDA with no flaws associated with the software. It has increased its services to incorporate features like implementation, configuration, database development, CTMS configuration, and comprehensive Application Service Provider services under a SaaS model. Its user base covers a wide spectrum, from small start-ups to larger corporations.
Clario is a research and technology firm specializing in healthcare, with a particular emphasis on pharmaceutical, biotech, and medical device research. The company employs scientific knowledge, global reach, and a comprehensive endpoint technology platform to conduct decentralized, hybrid, and site-based trials. Clario's strength is in its unique technology platform, which integrates eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. Operating from 30 facilities across nine countries, Clario's team of experts have overseen the successful completion of more than 19,000 trials, resulting in 870 regulatory approvals, affecting over five million patients in 120 countries. Over the past 50 years, the company has focused on continuous innovation to enhance and streamline clinical trials.
Advarra is a company that specializes in enhancing the conduct of clinical research. The firm brings together life sciences companies, CROs, research sites, investigators, and academia at the crossroads of safety, technology, and collaboration. Advarra offers in-depth solutions aimed at safeguarding trial participants, boosting the performances of clinical sites, and ensuring compliance, through trusted IRB and IBC review solutions, innovative technologies, experience-based consultation services, and solid links within the industry. The mission of Advarra is to advance clinical trials to more efficient, smarter, and faster.
Vsoft Infoware, Inc., based in Princeton, New Jersey, was established in 1996 and now possesses global outreach with offices in the USA, India, and the UK. The initial focus of the company was on e-clinical product development, kicking off in 2004, with their primary offerings today being the Clinfoware System and Reporting. Their team comprises industry professionals with backgrounds in Information Technology, Computer Sciences, and Clinical Operations, inclusive of areas like Clinical Trial Management, Data Management, Medical Affairs, Medical Writing, Biostatistics, and SAS programming. Furthermore, the firm owns an ISO 9001:2015 accredited development center in India. A critical resource for the pharmaceutical, biotech, and CRO industries, Vsoft is innovatively transforming outdated clinical trial systems with a comprehensive, interactive method, thereby enhancing clinical trials' likelihood of success.
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Anju is an organization committed to overcoming challenges in life science information management. Its key solutions, including TrialMaster, IRMS MAX, and TA Scan, help streamline drug and device discovery and commercialization processes. Anju's mission revolves around a customer-centric approach, offering optimum value life science solutions while keeping complexities at bay. These solutions are utilized by various entities in the pharmaceutical industry, clinical research organizations, and medical device companies. They facilitate the flow of data between Anju's solutions and allow seamless communication with third-party systems. Anju falls under the portfolio of Abry Partners, an experienced private equity investment firm with a sector-focused approach.
eClinical Solutions is a firm assisting life sciences organizations globally to fast-track clinical development efforts. Through the utilization of their specialized biometrics services and elluminate Clinical Data Cloud, they deliver the backbone for digital trials. The integration of the elluminate platform and eClinical Biometrics Services allows clients to gain self-administered access to all their data in a central locale. This is coupled with sophisticated analytics, supporting clients in making intelligent and expedited business choices.
Ennov, an independent cloud software vendor, proposes a regulated content management platform, and five solution sets built on top of this platform, each tailored for the Life Sciences sector. These are Quality Management, Regulatory Compliance, Clinical Trial Management, Pharmacovigilance system, and Pharmaceutical Event Management. These tools assist organizations in complying with internal and regulatory standards. The Ennov platform features built-in electronic signature and audit trail, LDAP synchronization, and connectors. Despite being generally deployed as a cloud solution, the Ennov platform can also be installed on-premises.
Flex Databases offers a platform designed for overseeing clinical trials. The platform incorporates 13 modules that encompass the entirety of a clinical trial—from its initiation to pharmacovigilance—with the option to employ each module separately or as an assembly for managing all proceedings. The modules designed by Flex Databases confirm to 21 CFR Part 11 regulations, as well as other international guidelines. The company makes available adaptable and modifiable baseline system versions, inclusive of complimentary updates, and also undertakes customizations to cater to specific client needs. Furthermore, Flex Databases does not call for enduring contracts, with the shortest contract period being 90 days.
Axiom functions within the biotechnology, device and pharmaceutical sectors, delivering advanced eClinical, EDC and Data Management solutions. The organization serves small and medium-sized entities, offering a range of comprehensive, easy-to-use business features or components. These majorly include EDC, DM, IWRS, CTMS, AE/SAE Tracking, Safety Database and continuous project and clinical reporting. The ability of Axiom allows establishments to devote more time and resources towards clinical research, easing them of the bother of acquiring and managing the technology needed for such activities. To maintain the quality of their services, Axiom operates an alert Customer Care team accessible all week, connecting with end-users to respond to inquiries, solve problems, and conduct regular training sessions. Also, Axiom associates with companies providing important clinical research services, like project management and monitoring services, central labs among others.
Mednet, a healthcare technology firm, concentrates on delivering eClinical solutions for the global life sciences community. Mednet's adaptable eClinical platform focuses on electronic data capture (EDC), improving the efficiency of clinical studies of different types and sizes. Besides just EDC, Mednet offers a broader solution set required to create and manage various clinical research, adapting to ever-changing demands and requirements. For the past two decades, entities operating in the pharmaceutical, medical device, biotechnology sectors and Contract Research Organizations (CROs) globally have relied on Mednet's technology innovation and reliability.
Accenture is a professional services corporation that has global capabilities in cloud, digital, and security domains. With proficiency and dexterity spanning across more than 40 sectors, Accenture provides a range of services such as Strategy and Consulting, Technology and Operations Services. It also features something named Accenture Song, powered by an extensive network of Advanced Technology and Intelligent Operations centers. It caters to clients in more than 120 countries, harnessing the capability of transforming changes into values to foster shared success.
ArisGlobal is a firm in the life sciences sector that focuses on enhancing the process through which life science companies develop novel breakthroughs and launch new products. Its principal offering is an end-to-end drug development technology platform referred to as LifeSphere. This integrates their unique cognitive computing engine to fully automate essential drug development tasks. Informed by nearly four decades of experience and a long-term perspective, LifeSphere is designed to improve efficiency, assure compliance, and decrease cost through multi-tenant Software-as-a-Service (SaaS) structure. ArisGlobal's main office is located in Waltham, MA, with additional regional offices in Europe, India, Japan, and China.
Medrio strives to improve 100 million lives through the optimization of clinical trials. Established in 2005, Medrio's network is driven by positivity and common objectives. The company provides eClinical solutions designed to be adaptable for any type of clinical trial, from traditional setups to entirely decentralized trials. Their unified platform offers simplified solutions that are not only easy to use but also easily scalable. Medrio's commitment is mainly to the enhancement of clinical research, focusing on the delivery and implementation of efficient, clear, and sophisticated solutions. The core company values thus center around a customer-oriented philosophy and a mindset for top-tier performance.
Octalsoft operates in the domain of tech-based solutions and software systems, aimed at creating seamless and robust infrastructure for businesses. Specializing in web and mobile-based solutions, Octalsoft's work primarily revolves around sectors including Clinical Research, Pharmaceuticals, and Hospitals. The company allows for deployment flexibility, with options for either a Software as a Service (SaaS) model or on-premise implementation. Their systems meet regulatory and quality standards, further compounded by solid security measures.
Octalsoft's strengths lie in implementing easy-to-use, risk-minimizing solutions that enhance value for the user. Through an agile delivery methodology, the company caters to unique business and project requirements within a set time frame and budget. Additionally, Octalsoft also offers a range of services including developing custom and mobile applications, with dedicated application, database, and hosting support.
Thermo Fisher Scientific Inc. is a global entity dedicated to serving the domain of science. The corporation concentrates on empowering its clients to tackle challenges in various scientific fields. This includes support in the facilitation of life sciences research, addressing intricate analytical problems, enhancement of laboratory productivity, as well as aiding both diagnostic improvements in patient health and the creation and manufacturing of transformative therapies. Thermo Fisher Scientific Inc. provides a wide range of technologies, purchasing facilities, and pharmaceutical services through widely recognized brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
Signant Health is a firm that specializes in the production of evidence used in clinical studies. Its operation revolves around employing software applications, vast therapeutic understanding, scientific knowledge, and operational skills to effectively collect, amalgamate, and disclose high-quality evidence. The company assists in clinical research across traditional, virtual, and hybrid lifecycle models. Signant Health has been a trustworthy solution provider for eCOA, eConsent, RTSM, supply chain oversight, and data quality analytics over two decades. It serves a variety of sponsors and Contract Research Organizations (CROs) of different levels, including high-profile pharmaceutical organizations.
Gartner Research
Features of Life Science E-Clinical Systems
Mandatory Features:
Clinical data intake — Includes all applications used to collect clinical evidence from principal investigators, sites, diagnostic partners and trial participants, and supporting solutions.
Trial content — Includes the collection and management of trial records in the trial master file, including all site documents, such as those required for informed consent, training records and site documents.
Clinical data analysis — The statistical analysis of trial data by biostatisticians, and preparation and validation of data for submission to regulators.
Clinical supply — Administration of trial investigational products (IPs), and supply of these products, often randomized, from a supply depot to clinical sites to support trial conduct.
Site and patient support — Management and engagement of sites and patients throughout trial conduct, from participant engagement efforts during trial to site-sponsor communications as well as trial content management.
Trial management — Involves the management and oversight of trial operations, including tracking trial milestones, managing sites and payments, and monitoring and oversight of site operations.
Clinical data cleaning — All solutions used to review, prepare and clean trial clinical data. This function includes coding medical terms, resolving data queries, external data integration, and mapping data to the structured data tabulation model standard, which is required for regulatory submission.