Eliminate “document chaos” and efficiently manage the complete lifecycle of your document-intensive clinical trial, from draft to approval. Use our sleek and intuitive platform to create, organize, store, track, and manage the versioning of electronic documents. You can also remotely access, manage, and share documents from nearly any device.

Use the COSMOS Part-11 compliance online e-signature feature to complete FDA 1572, FDFs, and CDAs. While maintaining 21 CFR Part 11 compliance, a site-operated eDocs system allows for rapid transmission of regulatory papers between research sites and sponsors. Remember, our software is entirely adaptable to users’ needs and scalable to grow with your research requirements.

Keep Track of Documents Relevant to a Specific Place

Instead of filling GCPs, CVs, IATA, SOPs, medical files several times, just file these documents once the COSMOS eDocs. This robust e-tool will handle version control and integrate them into each study. eDocs eliminates the mounting inefficiencies associated with the inability to manage islands of improperly organized documents.

Manage the ISF Digital Binder
Minimize regulatory compliance risks by organizing all relevant documents following clinical study-specific requirements. With COSMOS ISF, you can improve compliance for research site personnel, CRAs, and clinical study teams while allowing a certain level of adaptability.
Expedite the completion of regulatory documentation while staying compliant with the global regulatory requirements for document archiving. Also, ensure secure site documentation, prevent unauthorized access, and improve sponsor or site satisfaction.

End-to-end Handling of FDA 1572, CDA, FDF, and CTA in digital format.
You can modify and collect electronic signatures with the COSMOS Part-11 compliance on the line e-signature tech. Also, you can submit them in a regulation binder for the clinical research project.

Track everything from training to enrollment and randomization to site visits
Create, edit, and manage all log files in COSMOS and save them in a single location. eDocs ensures real-time availability of files, making them accessible to the authorized end-users.

Activate remote administrative options
By shifting to a single digital environment, all clinical study documents and data can be managed remotely. Our software ensures real-time access to data no matter your location. This makes alliances with research partners and third-party organizations much easier. Remember, the level of document visibility and access is determined through controlled access configuration.
COSMOS Part-11 and HIPAA compliant cloud-based systems eliminate the requirement for a separate remote access security infrastructure at a research site.

Eliminate Duplication in Multi-Center Administration
With multicenter clinical studies, the coordinating center needs greater control and access to the specific study locations. Our software facilitates document version control and effective history management of obsolete versions of electronic documents. It offers an audit trail of who made various changes and when. Also, it provides a signature and time stamp on each update made to a specific document, including changes made by multi-user collaboration.