Gartner defines an e-clinical system as the software solutions or platforms used to conduct clinical trials, together supporting the study setup, conduct and analysis of the clinical research process. The clinical trial process begins with a protocol, which defines the trial methodology, and ends with trial results and study endpoints that support final study conclusions in a clinical study report. E-clinical systems support this end-to-end process by collecting, cleaning and interpreting clinical trial data as well as supporting other trial processes such as site monitoring, biostatistics and clinical supply.
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.
Medidata Platform is a software designed to support clinical trial processes by providing data management, analytics, and monitoring capabilities. It enables organizations to collect, manage, and analyze clinical research data through integrated modules for electronic data capture, trial planning, randomization, and risk-based monitoring. The software offers tools for protocol development, site management, patient engagement, and regulatory compliance. It aims to streamline workflows, maintain data integrity, and facilitate efficient study execution. By enabling centralized data access and comprehensive reporting, Medidata Platform assists in enhancing decision-making and operational oversight within clinical research environments.
Veeva Vault Platform is a software designed to manage content and data in a single cloud environment, supporting business processes across regulated industries. The software allows organizations to create, store, and collaborate on documents and data while ensuring security, version control, and compliance with regulatory requirements. Veeva Vault Platform offers configurable workflows, metadata management, and audit trails, which enable organizations to automate processes and maintain data integrity. The software is built to address challenges related to information silos and fragmented data by offering centralized access and control, aiming to improve operational efficiency and facilitate collaboration among teams.
Caidya Clarity is a software designed to support clinical trial management by providing a unified platform for tracking study progress, managing operational data, and facilitating communication among stakeholders. The software offers tools for real-time data visualization, centralized document management, and risk identification, which enable organizations to monitor site performance and regulatory compliance throughout the clinical research process. Caidya Clarity addresses the business need for improved oversight and coordination in clinical operations by streamlining workflows, supporting decision-making with actionable insights, and enhancing collaboration in clinical trial execution.
Clindex is a software designed for managing clinical trial data and processes. It provides functionalities such as electronic data capture, randomization, inventory management, and patient tracking. The software allows users to design studies, collect and monitor trial data, and generate reports, supporting compliance with regulatory requirements in clinical research. Clindex aims to streamline the operational aspects of clinical trials by automating data entry, improving data integrity, and facilitating the monitoring of study progress. It is used to address business challenges related to data management, operational efficiency, and regulatory compliance in clinical research environments.
Veeva Vault Clinical Suite is a software designed to provide unified clinical operations and data management for the life sciences industry. The software offers integrated capabilities for clinical trial management, electronic trial master file management, study start-up, site management, and clinical data capture. It facilitates end-to-end trial processes by enabling collaboration, managing documents, and maintaining regulatory compliance in clinical research activities. The software addresses the challenge of disconnected systems by centralizing study information, streamlining workflows, and supporting real-time data access for stakeholders involved in clinical trials. Vault Clinical Suite is intended to improve study execution, increase operational oversight, and reduce manual effort by automating routine tasks and supporting standardization across clinical programs.
Clario is a software that provides digital security and privacy management solutions for individuals. It integrates antivirus protection, VPN functionality, ad blocking, and identity monitoring features within a unified interface. The software aims to help users safeguard devices from malware, secure internet connections, block intrusive ads, and detect potential threats to personal information. Clario facilitates easy monitoring of device vulnerabilities and privacy risks, helping users manage security settings and identify areas requiring attention. It addresses business problems related to cyber threats, privacy concerns, and secure data access for day-to-day digital activities, offering a centralized approach to managing personal and device safety online.
Clinical Conductor is a software developed for managing clinical research operations, aiming to streamline the administration of clinical trials for research sites, hospitals, health systems, and academic institutions. The software supports protocol management, participant scheduling, budgeting, and tracking of regulatory compliance activities. It provides tools for financial management, including invoicing and payment tracking, and facilitates collaboration among research team members. Clinical Conductor is designed to address operational inefficiencies by enabling centralized data management, workflow automation, and real-time reporting, supporting organizations in the planning, execution, and oversight of research studies.
Clinical Trial Management is a software designed to streamline and coordinate the various processes involved in clinical research studies. The software supports the planning, tracking, and management of clinical trial activities, including scheduling, monitoring participant progress, site management, and regulatory compliance documentation. It enables centralized storage and access to trial data, facilitates secure collaboration among stakeholders, and helps automate reporting and monitoring functions. Clinical Trial Management software aims to address challenges such as data consistency, trial oversight, and efficient resource allocation, contributing to improved operational efficiency and regulatory adherence in clinical research environments.
Clinion is a software designed to facilitate the management and conduct of clinical trials. The software offers features such as electronic data capture, remote data monitoring, randomization, and patient recruitment management. It assists organizations in streamlining clinical operations, handling regulatory compliance, and ensuring data integrity throughout the trial lifecycle. By providing tools for case report form design, workflow automation, and real-time reporting, Clinion addresses business problems related to manual data handling, inefficient trial processes, and regulatory challenges in clinical research. The software supports integration with various healthcare systems to enhance data connectivity and trial oversight.
Curebase is clinical trial management software that facilitates the design, launch, and administration of decentralized and site-based clinical studies. The software supports patient recruitment, electronic consent, remote data capture, and integration with wearable devices, enabling data collection from a variety of settings including at-home and traditional research sites. Curebase provides tools for protocol configuration, study monitoring, regulatory compliance, and data analytics, addressing challenges such as participant engagement, operational efficiency, and flexible trial deployment. Researchers and organizations utilize this software to streamline study workflows, improve data quality, and manage trial logistics for diverse clinical research programs.
Datatrak Enterprise Cloud is a software designed to facilitate clinical trial management through centralized electronic data capture and study management capabilities. The software offers tools for protocol design, patient enrollment, real-time data collection, and study monitoring. It supports secure data storage, regulatory compliance, and audit trails, enabling research organizations and sponsors to manage trial workflows efficiently. The software streamlines collaboration among clinical teams by providing access to study information and analytics, aiming to improve data accuracy and operational transparency throughout the lifecycle of clinical trials.
eClinical Suite is a software developed by Anju Software that facilitates the management of clinical trials by offering tools for electronic data capture, study management, and workflow automation. The software supports functions such as protocol design, subject enrollment, monitoring, and regulatory compliance. eClinical Suite enables research teams to streamline the collection, validation, and reporting of clinical trial data, aiming to improve operational efficiency and ensure data integrity. By integrating modules for randomization, electronic patient-reported outcomes, and site management, the software addresses challenges related to coordination and oversight in multi-site trials. eClinical Suite is utilized to manage the entire lifecycle of clinical research studies, supporting regulatory requirements and standardized data handling.
Elluminate Clinical Data Cloud is a software developed by eClinical Solutions that integrates and manages clinical trial data from various sources to support biopharmaceutical and medical device development. The software provides centralized access to clinical, operational, and reference data, enabling data ingestion, aggregation, mapping, curation, and visualization. Elluminate Clinical Data Cloud facilitates data review and analytics workflows to accelerate clinical research by improving data quality and reducing manual processes. The software allows for timely insights and decision-making through secure data management and intuitive analytical tools, offering functionality that addresses the complexity in clinical trial data integration and supports regulatory compliance in research environments.
Ennov’s Clinical software suite offers a comprehensive solution for managing all clinical trial data, supporting sponsors, CROs, investigators, and patients from planning through close-out. The suite includes Clinical Data Management tools (Ennov EDC, Ennov RTSM, Ennov ePRO) and Clinical Trial Management tools (Ennov CTMS, Ennov eTMF), available for both cloud and on-premises deployment. Additionally, the Ennov Clinical eLearning application rounds out our innovative product offerings.
Benefits:
- Centralized management: Consolidate all clinical data and processes in one solution.
- Enhanced performance: Automate to reduce manual errors and improve productivity.
- Global collaboration: Connect teams globally with a multilingual, user-friendly platform.
- Increased visibility: Proactively gain insights to address potential quality issues.
Flex Databases is a software designed to support clinical research and operations management by offering a modular platform that includes applications for clinical trial management, electronic trial master file, pharmacovigilance, learning management, quality and risk management, finance and invoicing, project and resource management, and electronic data capture. The software enables organizations involved in clinical development to streamline processes, manage regulatory compliance requirements, centralize data, and enhance control over trial documentation and workflows. Flex Databases addresses the need for operational efficiency and data integrity in clinical studies across different phases and therapeutic areas.
Fusion eClinical Suite is a software designed to support the management of clinical trials by offering integrated solutions for data collection, monitoring, and reporting. The software provides electronic data capture, clinical data management, and real-time access to study metrics, enabling clinical teams to streamline workflows and ensure regulatory compliance. Fusion eClinical Suite addresses challenges associated with data accuracy, protocol adherence, and efficient communication among stakeholders, aiming to improve decision-making and enhance the efficiency of clinical research processes.
iMednet is a software designed to support electronic data capture and management for clinical research. It provides tools for study setup, subject enrollment, data collection, and monitoring. The software offers features such as randomization, edit checks, audit trails, and data validation to ensure data quality and compliance with regulatory standards. It enables integration with external systems and facilitates streamlined communication between research teams. iMednet aims to address business challenges associated with managing clinical trial data efficiently, helping organizations maintain accurate and reliable records while adhering to study protocols and industry regulations.
INTIENT is a software offered by Accenture that facilitates data and technology integration across life sciences organizations. The software provides capabilities for managing and analyzing health, research, and patient data to support drug development and commercialization processes. INTIENT enables secure data sharing and workflow automation to improve collaboration between researchers, scientists, and clinicians. The software aims to streamline operations, accelerate research, and enhance insights by providing a unified platform for data integration, real-time analytics, and workflow management. INTIENT addresses challenges related to data silos, compliance, and scalability within the life sciences sector.
IQVIA Orchestrated Clinical Trials is a software designed to support end-to-end management of clinical trial processes. The software enables users to plan, execute, and monitor clinical studies through integrated workflows that address trial design, site selection, operational tracking, patient enrollment, and data collection. It offers features such as real-time insights into trial progress, centralized data management, and automated reporting, which aim to improve study efficiency and protocol compliance. The software addresses common business challenges faced in clinical research, including fragmented communication, manual tracking, and delays in data accessibility, enabling organizations to optimize resource allocation and enhance decision-making throughout the lifecycle of a clinical trial.
LifeSphere Clinical is a software designed to support clinical trial management and operations for life sciences organizations. The software provides functionalities that enable planning, execution, and monitoring of clinical studies. It includes features such as electronic trial master file management, study startup automation, site management, and regulatory compliance support. LifeSphere Clinical facilitates collaboration among stakeholders by organizing documentation and workflows, helping reduce manual processes and supporting adherence to industry standards. The software addresses business challenges related to data accuracy, regulatory requirements, and the complexity of managing clinical research activities by centralizing and streamlining clinical trial information and processes.