Integrated Clinical Trials Management System
Clinical Trials Management System (CTMS)
COSMOS CTMS allows you to design a clinical study, maximize insights and manage clinical trials effortlessly. This next generation AI clinical trial management system can be configured to address various challenges associated with clinical trials management. It improves user accessibility, streamlines communication, reduces manual operations, and eliminates redundant tasks to facilitate more efficient clinical trials.
Improve engagement, participation, and retention
Use various tools to streamline patient enrollment, improve patient engagement and retention. Stay in contact with the patients using alerts to minimize no-show appointments and the overall engagement in your clinical study.
Consistency is key
COSMOS’ powerful site and investigator database expedite the process of aligning one or more study sites with GCP, 21 CFR Part 11, and other compliance requirements to guarantee safe and high-quality clinical research.
eSource
Rapid study initiation is an advantage for clinical research sites. COSMOS eSource expedites site readiness by offering centralized source templates, allowing study teams to quickly build and implement their study source data framework. Additionally, automated validation rules enforce data accuracy measures, minimizing discrepancies at the point of entry. This reduces the data quality verification time, ensuring that the captured data is compliant and ready for immediate analysis.
Unlike traditional paper-based systems—where monitors must sift through bulky binders to validate subject data—COSMOS eSource consolidates all relevant trial information into a single, easily navigable digital environment. Investigators, site monitors, and research coordinators can seamlessly review:
- Subject medical records
- Informed consent documentation (ICFs)
- Laboratory results & imaging reports
- Safety event logs (AE, SAE)
- Protocol deviations
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eDocs
COSMOS eDocs is an electronic document management solution that streamlines the entire lifecycle of an Investigator Site File (ISF) or electronic investigator site file (eISF). This 21 CFR Part 11 compliant platform reduces inefficiencies, enhances collaboration, and ensures seamless regulatory compliance while optimizing research site workflows.
With remote accessibility and a user-friendly interface, COSMOS eDocs empowers sites, sponsors, and CROs to manage ISF effortlessly. It ensures that every record is securely stored, easily retrievable, and compliant with global regulatory requirements.
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eConsent
The platform is accessible across multiple device types, providing patients with interactive and engaging multimedia to support informed decision making. Enhanced Informed Consent Process Principal Investigators PIs and research site teams can leverage COSMOS eConsent to share Informed Consent Forms ICFs and educational materials via the patient portal. COSMOS eConsent integrates effortlessly with existing site infrastructures, enabling quick and efficient deployment. These resources simplify complex terminology, ensuring patients fully understand study expectations and commitments before enrolling. COSMOS CTMS; built in TeleVisit feature allows site teams to conduct remote informed consent discussions, making the process more accessible and efficient.
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eFax
Clinical research sites handle a constant flow of sensitive documents – from patient records and lab results and regulatory forms. In an industry where over 70% of offices still rely on fax for document exchange
Transitioning to an integrated electronic fax (eFax) solution is critical for efficiency and compliance. COSMOS’s eFax feature brings faxing into the digital age within your clinical platform, allowing staff to send and receive medical documents securely without paper or standalone fax machines.
By leveraging cloud fax api technology, COSMOS ensures that protected health information (PHI) is transmitted with end-to-end encryption and stored in a controlled, auditable system – all in compliance with HIPAA and FDA 21 CFR Part 11 requirements. The result is a more streamlined workflow that lets research teams focus on patients and trials instead of chasing paperwork.
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