Expedite Your Clinical Trials and Achieve Study Goals Sooner
COSMOS is the pioneering clinical trial platform that bridges the gap between sponsors, CROs, and sites. No other platform in the ecosystem provides such transparent communication among all stakeholders. COSMOS has divided the clinical trial process into three distinct phases:
- Study Startup
- Study Run Time
- End of the Study.
Until now, sponsors and CROs have had to rely on multiple platforms or services to manage each phase due to the lack of an end-to-end solution. COSMOS revolutionizes this by integrating all these phases into a single, comprehensive system.
By leveraging AI, COSMOS generates budgets and allows for electronic budget negotiations. It also facilitates the sharing of essential study documents through a transparent exchange portal while maintaining the lifecycle of these documents seamlessly.
Until now, sponsors and CROs have had to rely on multiple platforms or services to manage each phase due to the lack of an end-to-end solution. COSMOS revolutionizes this by integrating all these phases into a single, comprehensive system.
By leveraging AI, COSMOS generates budgets and allows for electronic budget negotiations. It also facilitates the sharing of essential study documents through a transparent exchange portal while maintaining the lifecycle of these documents seamlessly.
Streamlining the Study Startup (SSU) Process
The Study Startup (SSU) phase, notorious for complexity and infamous bottlenecks, resembles navigating a maze blindfolded while juggling regulations, contracts, and expectations from multiple stakeholders. This outdated trifecta has proven adept at prolonging site selection processes from days into months of tedious inefficiency.
To sidestep these hurdles, sponsors increasingly turn to the outsourcing prowess of CROs, whose technological innovations and existing infrastructures significantly simplify this otherwise cumbersome journey. Yet paradoxically, many sponsors persist with traditional methods rooted firmly in the last century, relying heavily on an unholy trinity of Word, Excel, and Outlook.
Enter COSMOS, an AI driven beacon amidst the fog of traditional inefficiencies. How? Unlike legacy systems, COSMOS swiftly identifies qualified sites using artificial intelligence and compresses the SSU timeline from months down to weeks. This unique approach isn’t merely innovative, it’s downright revolutionary. By cleverly dissecting the startup process into multiple parallel workflows, which are seamlessly orchestrated and synchronized on one comprehensive platform.
COSMOS ensures clarity, transparency, and an undisputable single source of truth aligning seamlessly with the demands of today’s life sciences industry. Also obliterates information silos, connecting sponsors, CROs, and research sites within a single, transparent ecosystem. COSMOS SSU is methodically organized into eight essential steps:
- Site Identification
- Confidentiality Agreement Execution (CDA)
- Site Feasibility Assessment (SFQ)
- Pre Site Visit Coordination (PSV)
- Budget Negotiation AI assisted
- Clinical Trial Agreement Execution (CTA)
- Regulatory Essential documents
- Site Initiation Visit (SIV)
Ensuring Compliance Throughout the Study Run Time
The COSMOS Study Center is the ultimate collaboration platform designed specifically to streamline communication and coordination between research sites, sponsors, and CROs. The Study Center consists of multiple features like study training management (LMS) system one frequent culprit behind delayed site initiation is the completion and tracking of mandatory training for site teams. Gone are the days when research teams had to juggle multiple portals or sift through endless emails to verify training statuses. This unified solution enables sponsor teams to effortlessly assign training based on specific roles, manage completion statuses, and monitor compliance all from a single, user friendly platform.
The COSMOS Study Center is your single, centralized hub for collaboration, clarity, and continuous improvement, effectively bridging communication gaps and enhancing the entire clinical trial lifecycle.
By providing regular status newsletters creation, distribution to the study sites with seemless transparent with sites, the comprehensive study FAQs, and direct access to useful study portal URLs, COSMOS equips site and sponsor teams to operate with unmatched clarity and efficiency. With single sign-in, the sponsor and site teams ensure transparency in communication and maintain compliance without waiting for email responses.
Sites benefit directly by effortlessly reviewing and downloading updated regulatory documents from the integrated electronic investigator site file (eISF) module, removing delays caused by waiting for external monitors.
Ensure Accurate Safety Report Distribution and Maintain Compliance
COSMOS eVault is the clinical trial industry’s ultimate companion, consolidating safety reporting, acknowledgments, and compliance monitoring into one powerful, user friendly platform. Say goodbye to scattered documents, manual processes, and anxiety filled compliance checks COSMOS has your back. This purpose built solution harmonizes workflows, automates complex processes, boosts efficiency, and ensures your study is perpetually audit ready. Real Time Safety Record Management With COSMOS eVault, sites and monitors have instant, real time access to essential safety documents, streamlining compliance across multiple sites in various country. This seamless automation drastically reduces administrative burdens, enhances compliance, and ensures that investigators and sponsors are always prepared for inspections without breaking a sweat. Thanks to our integrated platform, once an investigator acknowledges a safety report, it automatically archives into the electronic regulatory binder rBinder, eliminating tedious manual uploads and downloads. Safety Letter Acknowledgement Simplified COSMOS built in automated distribution system sends precise notifications regarding safety events including adverse events, serious adverse events SAEs, and suspected unexpected serious adverse reactions (SUSAR’s) or Vaccine Adverse Event Reporting System (VAERS) directly to the relevant stakeholders. Robust and scalable document management COSMOS eVault is a scalable and customizable SaaS solution designed for secure, compliant document management.
Significant cost savings effective safety reporting is traditionally a hidden but substantial cost. Continuous regulatory monitoring ensures that every study site, anywhere in the world, remains inspection ready and compliant. Enhanced Compliance and cost efficiency our robust automated tracking system guarantees timely, secure, and compliant document distribution. COSMOS addresses this directly, streamlining the distribution process to achieve significant budgetary savings. By eliminating manual processes, COSMOS Safety reporting solutions enhance efficiency, compliance, and patient safety keeping your clinical trials running smoothly and securely
End of Study Document Management (EOS): Optimizing Clinical Data Management Distribution Expenditure COSMOS seamlessly integrates with electronic data capture EDC, IWRS, and eCOA systems, ensuring secure, automated data transfer and precise allocation to study sites. It expertly distributes critical safety documents among investigators, sites, and authorized personnel while providing real time monitoring and acknowledgment reporting.