COSMOS Clinical Trial Management System (CTMS) is designed to optimize the trial operations by leveraging AI-powered automation to optimize processes, reduce administrative burden, and improve research outcomes.
As clinical trials grow more complex and data-driven, modern CTMS solutions like COSMOS incorporate advanced technologies such as artificial intelligence (AI) and automation to enhance efficiency, compliance, and decision-making.
COSMOS CTMS streamlines study management, study coordination, and patient tracking by centralizing all trial information and activities in one platform. Due to the instant transparency of a study status, the teams can confidently make data-driven decisions faster. Such platforms streamline collaboration between investigators, allowing real-time data entry and review. COSMOS CTMS is a comprehensive, next-generation eClinical platform that helps research organizations overcome the challenges of traditional trial management
Designed for global trials, it capably handles complex multi-site studies by tracking participants and recruitment in real time. The system also provides robust reporting and monitoring across dispersed trial locations.
Some key features of COSMOS CTMS include:
Participant Engagement Tools: Built-in communication features help enhance participant retention by sending handy alerts and appointment reminders to reduce no-show appointments
Regulatory Compliance Alignment: The system aligns sites with Good Clinical Practice (GCP) guidelines and FDA 21 CFR Part 11 requirements, ensuring consistency and high-quality, compliant research
Integrated Scheduling Calendar: A unified calendar allows coordinators to schedule participant visits within protocol windows and flags visits that are upcoming or overdue
Automated Recruitment Funnel: COSMOS can import and manage subject databases, automatically generate leads via website and social media, and send system-generated calls, texts, or emails to pre-screen participants – all within a centralized lead management funnel
Document Hub: A centralized, secure repository houses all personal, trial-related documents for study teams and sites, ensuring seamless access, version control, and it will enhanced operational efficiency.
Budget Negotiation and Billing: The platform streamlines stipend management and site invoicing with real-time tracking, ensuring reconciliation and billing compliance. COSMOS leverages AI-driven budget negotiation to determine fair market value, empowering sites with stronger financial positioning and optimized study budgets.
Two-Way SMS Communication: COSMOS CTMS integrates text messaging to boost recruitment and retention, sending reminders and updates to participants no matter where they are. These features work together to create a unified workflow ecosystem, enabling sponsors, CROs, and site teams to execute trials more efficiently from start to finish.
AI-Powered Clinical Trial Management: Artificial intelligence is playing an increasingly key role in modern clinical trial management. AI is being integrated into CTMS platforms to automate complex tasks. By leveraging these AI capabilities, COSMOS CTMS helps study teams make faster decisions.
Meet the Regulatory Compliance and Data Security
COSMOS CTMS helps ensure that trials adhere to industry regulations by aligning sites and workflows with standards like GCP (Good Clinical Practice) and FDA 21 CFR Part 11, which governs electronic records and signatures
The system provides a centralized repository for regulatory documents and automatically maintains detailed audit trails of all trial activities, making it easier to prepare for inspections and demonstrate compliance. COSMOS CTMS follows the eTMF v3.4 standard to build the electronic investigator’s site file (ISF)
For instance, every activity throughout the system, maintain the audit trail like data access in the CTMS, can be logged and time-stamped, allowing regulators to trace any changes – a key factor in passing audits and inspections.
CTMS platforms also issue automated reminders for critical protocol milestones (such as patient visits and document or certificate expiration) to ensure that nothing falls through the cracks to meet regulatory requirements. Integrating compliance checkpoints and robust security measures directly into the trial workflow, a CTMS like COSMOS ensures data integrity and reinforces trust that the study adheres to the highest ethical and regulatory standards.
Automated Workflow Efficiency
One of the benefits of a CTMS is the automation of routine trial management tasks. Which drives efficiency and reduces human error. By automating workflows, COSMOS platforms free up research staff to focus on more strategic activities. For example, a CTMS can automatically schedule patient appointments, track enrollment, and completion status, and send the reminders for upcoming tasks – ensuring that trial activities stay on schedule.
This automation minimizes the overhead and helps prevent delays or protocol deviations by ensuring each step is completed on time. COSMOS CTMS also increases the efficiency of the recruitment process: it automatically generates and manages study leads through its integrated outreach tools, so potential participants are identified and pre-screened with minimal manual effort.
By leveraging tools like COSMOS Site CTMS, site, sponsors and CROs can run more efficient, patient-centric trials that ultimately bring new therapies to market faster – with greater confidence in their quality and compliance.
Supporting Decentralized Clinical Trials
Decentralized clinical trials (DCTs) have become a trend in the industry, allowing patients to participate in studies from their comfort zone. COSMOS CTMS and its associated tools support decentralized trial models by facilitating remote data capture, virtual visits (through telemedicine modules), and direct-to-patient communications. Decentralized trials empower patients to participate in study activities conveniently from their own environment, enhancing accessibility and comfort., and it’s one of the common topics in the clinical research industry.
Significant benefits of DCT:
By reducing the need for travel and in-person visits, decentralized trials have been shown to improve patient recruitment and retention rates, leading to shorter overall trial timelines. COSMOS CTMS features help the site to meet the FDA diversity initiative.
Sophisticated CTMS solutions, like COSMOS, serve as the backbone of modern clinical trials, weaving together cutting-edge functionalities such as eConsent for frictionless remote consent acquisition, telehealth for real-time virtual site engagements, and intuitive mobile interfaces that empower patients to submit outcomes from virtually any location. By dissolving logistical barriers and fostering effortless remote involvement, a CTMS transforms decentralized trials from an ambitious concept into an operational reality where accessibility and patient-centricity are not just ideals but foundational principles.
Enhancing Study Subject Engagement and Retention:
Improving clinical trial retention rates depend on maintaining patient engagement strategies throughout the study lifecycle. With clinical trial dropout rates averaging 30% — often driven by patient burden factors like time commitments and travel demands — sponsors and CROs must prioritize participant-centric trial design to ensure data integrity and study success. Proactive solutions targeting patient retention in clinical trials can mitigate attrition risks while enhancing trial efficiency and outcomes.
COSMOS CTMS can significantly improve patient engagement by providing tools that keep participants informed, reminded, and motivated to continue. For example, it uses automated alerts and two-way text messaging to stay in touch with participants, sending appointment reminders and study updates that educate the study subjects, encouraging them to reduce no-shows and keep patients involved. A dedicated patient portal allows subjects to keep track of study updates on a regular basis.
An advanced CTMS makes the trial experience more convenient and responsive. It increases the likelihood that participants will remain in the study until completion, thereby improving the trial’s success rate.
Pay streamlined for Clinical Sites
COSMOS-Pay significantly reduces the administrative burden on clinical sites. By automating the payment process, the platform allows site teams to manage payments with a simple click, ensuring a seamless experience for both staff and participants. Regardless of whether payments are made via physical cards or digital wallets, the funds are available instantly.
The COSMOS-Pay system integrates effortlessly with the site’s CTMS, eliminating the need to re-enter participant details. This integration minimizes manual errors, saves valuable staff time, and maximizes productivity.
Simplified Tax Reporting:
COSMOS-Pay seamlessly handles year-end tax reporting. The system automatically generates reports, detailing those eligible for tax forms, saving sites the time-consuming task of manually gathering and sending out tax documents.
Versatile Payment Methods:
Participants have the freedom to select their preferred payment method, ensuring convenience with no added expenses for sites or sponsors. Options include:
- Reloadable COSMOSPay debit cards
- Digital wallets or virtual debit cards
Effortless Subject Reimbursements:
Reimburse patients promptly for a variety of out-of-pocket expenses such as travel, meals, tolls, parking, and other transportation costs. The payment process is swift, ensuring participants are compensated for their efforts without delay.