COSMOS eDocs: Transforming Clinical Trial Document Management
Effective document management is essential and challenging in the dynamic field of life sciences. The regulatory standards require rigorous oversight of documentation, version control, and compliance with 21 CFR Part 11.
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.
COSMOS eDocs offers a seamless, secure, and regulatory-compliant platform that
- Automates document workflows to eliminate inefficiencies.
- Ensures secure e-signatures for faster approvals.
- Provides remote access for real-time collaboration.
- Enhances multi-site trial coordination.
With COSMOS eDocs, you can transform how your research site handles documents, ensuring that trials fully comply with regulatory requirements.
Managing and Completing Study Startup Essential Documents
During study startup, research teams must compile and complete a set of essential regulatory documents required for clinical trial initiation.
These include items like FDA 1572 forms, investigator curriculum vitae, IRB approvals, training certificates, and trial agreements – all critical to demonstrate compliance with ICH GCP guidelines and regulatory requirements.
COSMOS eDocs streamlines this process by centralizing all startup documentation in a secure digital binder, eliminating scattered files across systems
By digitizing the regulatory binder, the platform allows teams to gather, organize, and update required documents in one place, ensuring nothing is overlooked as the trial gets underway. Digital ISF can be accessible from any ware.
Efficiency and Compliance: COSMOS eDocs facilitates the efficient handling of study startup requirements while ensuring regulatory compliance at every step. The platform uses 21 CFR Part 11-compliant electronic signatures to complete key forms (e.g., FDA 1572, financial disclosure forms, CDAs, Protocol Signature Page, Investigators Agreement, Investigator Brochure, Data Privacy documents) entirely online.
Each essential document can be electronically signed through the system, providing a complete audit trail for regulatory review. This not only maintains compliance with FDA and ICH guidelines but also accelerates document turnaround by allowing rapid, remote transmission of regulatory paperwork between sites and sponsors.
The stakeholders (investigators, sponsors, IRBs, FDA ) can be granted controlled access to review and approve documents in the centralized system, it replacing back-and-forth emails and physical mail with a streamlined digital workflow. As a result, startup documents are completed faster and with fewer errors, keeping the study launch on schedule and audit-ready. Document exchange activities happen during study startup, and historically, these manual processes have been burdensome for sites and sponsors. By automating document collection, COSMOS eDocs frees up staff time and minimizes delays, helping research teams meet study startup timelines with less stress.
Audit-Readiness: The platform automatically manages document versioning – every time a file is updated (for instance, when a new or updated CV is provided), the system archives the old version and highlights the current one.
Regulatory guidelines require that original and all updated versions of essential documents be maintained throughout the trial, and COSMOS eDocs fulfills this by keeping a clear record of the document life cycle from draft to final approved version.
The audit-ready binders can be easily presented with confidence that every required startup document is in place, correctly signed, and version-controlled.
Why Choose COSMOS eDocs for Clinical Trials?
Streamline Your Documents with Smart Organization: Clinical trials generate a lot of critical documents, from FDA 1572 forms and clinical trial agreements (CTAs) to financial disclosures (FDFs) and regulatory compliance records. COSMOS eDocs centralizes all study documents in a single, intuitive platform, ensuring and eliminating redundancy.
- Easy to manage: Create, track, edit, and store documents securely in a structured environment.
- Cloud-Based Accessibility: Access and manage study documents from any device, anytime, anywhere.
- Advanced Search: Locate specific documents in seconds using advanced search features.
Security & Compliance: With HIPAA and 21 CFR Part 11 compliance, COSMOS eDocs protects sensitive data through role-based access controls, limited to the approved study, and multi-factor authentication (MFA). COSMOS eDocs provides a secure, 21 CFR Part 11-compliant e-signature solution that allows for legally binding approvals on essential documents like:
- FDA 1572 forms
- Clinical Trial Agreements (CTA)
- Confidential Disclosure Agreements (CDA)
- Financial Disclosure Forms (FDF)
Audit Trails: Every signature is timestamped, and the reason for the signature, is encrypted, double authentication, and securely stored, offering a transparent audit history of the digital signature and the document. COSMOS eDocs enables sponsors, CROs, and research sites to collaborate on ISF documentation, ensuring all essential study records are maintained, auditable, and easily accessible during site inspections or audits.
Remote Access & Real-Time Collaboration
Traditional paper-based document management creates bottlenecks in clinical research due to physical storage limitations, misplacing the documents, slow approvals, difficult to follow ALCOA+ principles and difficulty in document sharing. COSMOS eDocs removes these barriers by offering a secure, cloud-based digital repository that allows teams to:
- Work Remotely: Manage, review, and approve documents from any location—at the site, sponsor headquarters, or regulatory office.
- Facilitate Multi-Site Collaboration: Research teams in different locations can collaborate in real-time, making document revisions faster and more efficient.
Say goodbye to document delays! With our eISF, everyone can access documents from anywhere, anytime. This means faster turnaround times and less hassle for study monitors, who can check document status instantly without needing to contact the site team.
Automated Training & Credential Tracking
Keeping track of site staff training records, certifications, and qualifications is essential for compliance and audit readiness. COSMOS eDocs automatically track the expiration of the training record, and comply with the GCP principles.
- Monitor Expiration Dates: Automatically track expiring certifications (GCP, IATA, CVs, SOPs, medical licenses, etc.) and notify staff for renewal.
- Maintain a Centralized Repository: Store all personnel and site documents in one place, maintain the compliance, ensuring easy retrieval during audits or inspections.
Quickly create training logs: COSMOS eDOCS creates and maintains the study training logs, making it simple to comply with GCP guidelines and securely store them in the site training category. This will prevent documents from being misplaced and compliant.
Effortless Regulatory Compliance & Inspections
Regulatory inspections can be stressful, especially when dealing with disorganized or missing documents. COSMOS eDocs simplifies audit preparation by:
- Consolidating Compliance Records: Keep all regulatory, site, personal, and study-related documents in one secure location.
- Providing Instant Audit Readiness: Inspectors can quickly access required documents with automated tracking.
- Guaranteed the Data Integrity & Traceability: Every document activity is logged, with username, timestamped, and the action, ensuring compliance with FDA, EMA, and other global regulations.
Ready to take control of your clinical trial documentation? Experience COSMOS eDocs today!
COSMOS eDocs offers a seamless, secure, and regulatory-compliant platform that
- Automates document workflows to eliminate inefficiencies.
- Ensures secure e-signatures for faster approvals.
- Provides remote access for real-time collaboration.
- Enhances multi-site trial coordination.
With COSMOS eDocs, you can transform how your research site handles documents, ensuring that trials fully comply with regulatory requirements.
Managing and Completing Study Startup Essential Documents
During study startup, research teams must compile and complete a set of essential regulatory documents required for clinical trial initiation
These include items like FDA 1572 forms, investigator curriculum vitae, IRB approvals, training certificates, and trial agreements – all critical to demonstrate compliance with ICH GCP guidelines and regulatory requirements.
COSMOS eDocs streamlines this process by centralizing all startup documentation in a secure digital binder, eliminating scattered files across systems
By digitizing the regulatory binder, the platform allows teams to gather, organize, and update required documents in one place, ensuring nothing is overlooked as the trial gets underway. Digital ISF can be accessible from any ware.
Efficiency and Compliance
COSMOS eDocs facilitates efficient handling of study startup requirements while ensuring regulatory compliance at every step. The platform uses 21 CFR Part 11-compliant electronic signatures to complete key forms (e.g., FDA 1572, financial disclosure forms, CDAs, Protocol Signature Page, Investigators Agreement, Investigator Brochure, Data Privacy documents) entirely online. Each essential document can be electronically signed through the system, providing a complete audit trail for regulatory review. This not only maintains compliance with FDA and ICH guidelines but also accelerates document turnaround by allowing rapid, remote transmission of regulatory paperwork between sites and sponsors.
The stakeholders (investigators, sponsors, IRBs, FDA ) can be granted controlled access to review and approve documents in the centralized system, it replacing back-and-forth emails and physical mail with a streamlined digital workflow. As a result, startup documents are completed faster and with fewer errors, keeping the study launch on schedule and audit-ready. Document exchange activities happen during study startup, and historically, these manual processes have been burdensome for sites and sponsors. By automating document collection, COSMOS eDocs frees up staff time and minimizes delays, helping research teams meet study startup timelines with less stress.
Audit-Readiness: The platform automatically manages document versioning – every time a file is updated (for instance, when a new or updated CV is provided), the system archives the old version and highlights the current one. Regulatory guidelines require that original and all updated versions of essential documents be maintained throughout the trial, and COSMOS eDocs fulfills this by keeping a clear record of the document life cycle from draft to final approved version. The audit-ready binders can be easily presented with confidence that every required startup document is in place, correctly signed, and version-controlled.
Automated Running Logs: No Extra Work Required
COSMOS eDocs automatically maintains running logs, allowing study teams to focus on their workflow instead of spending time on manual data entry. Once a site team follows its standard study process, the system automatically updates log files—without extra effort. The study logs are continuously updated in the background call running logs.
The Benefits of COSMOS eDocs Running Logs
- Saves Study Coordinators Valuable Time – Manual data entry is unnecessary; the system updates logs automatically.
- Cuts Costs for Research Sites – Reduces resource workload, and minimizing resource expenditures.
- Ensures Accuracy & Reduces Errors – Real-time updates prevent discrepancies and maintain data integrity.
- Audit-Ready – Logs always meet GCP requirements, ensuring regulatory preparedness.
- Investigator Oversite – Ensure comprehensive year-round investigator oversight to maintain adherence to protocols, enhance study integrity, and foster regulatory compliance throughout the research lifecycle.
Automated Log Management with COSMOS eDocs
COSMOS eDocs efficiently manages and updates multiple critical study logs, including:
- Electronic Delegation of Authority Log—Assign, track, and document study responsibilities for each team member. The log updates whenever study personnel change.
- Study Training Log – Tracks training completion without much effort. Staff training records can generate and recorded them through the system, ensuring compliance with study protocols.
- Site Visit Log – Every monitoring visit, including remote review, and site interaction is digitally documented, and digitally sign the visit.
- Subject Screening Log – Automatically records details of screened subjects, maintaining accurate and accessible recruitment data.
- Subject Enrollment Log – tracks the enrolled participants in study with out any manual intervention and maintain up-to-date enrollment records.
- IP Master Log—Maintains a real-time inventory of investigational products (IP), tracking their usage and ensuring proper accountability.
- IP Dispensation Log – Records every instance of investigational product dispensation without any manual interaction, helping maintain compliance and prevent discrepancies.
- Informed Consent Version Log tracks all approved informed consent document versions, ensuring that only the most current version is used.
- Informed Consent Sign Log—Automatically logs when and by whom informed consent was signed, with the informed consent version signed by the study subject, providing an auditable record for regulatory compliance.
By eliminating manual log file maintenance, COSMOS eDocs significantly enhances study regulatory (ISF) documentation efficiency, and compliance. This automated solution allows research sites to remain audit-ready while reducing workload and operational costs. No extra effort, no missing updates—just a more innovative, more efficient way to manage study running logs. By centralizing, tracking, and automating the management of study startup essential documents, COSMOS eDocs significantly reduces the administrative workload associated with initiating a clinical trial. Clinical research professionals can confidently rely on the platform to keep all required documents organized, up-to-date, and readily accessible. The result is a faster, smoother study startup process that fully complies with regulatory guidelines while freeing teams to focus on executing the trial rather than shuffling paperwork. With COSMOS eDocs handling the heavy lifting of document submission, approval, and version control, study startup has become a more efficient and controlled endeavor from day one.
COSMOS eDocs for Study Startup Essential Documents
Essential Document Manager
All site, personal, and study startup essential documents are stored in one cloud-based platform, acting as an electronic regulatory vault accessible to authorized stakeholders. This centralization eliminates silos and duplicate filing – site staff uploads documents once, and they’re available for each relevant study. Take care of the study startup essential documents within the system and share them with the sponsor seamlessly.
Monitors and sponsors can remotely access the files they need, verify them, download with the audit trial, document lifecycle history, and facilitating transparency. They can issue the queries, monitor and close them.
Automated Submission & Approval Workflows
COSMOS eDocs automates the submission of documents for investigators’ approval and captures approvals with 21 CFR Part 11 e-signatures. The system tracks each document’s status (e.g., pending site signature, under review, approved) and sends notifications to ensure no required sign-off is missing. This automation streamlines communication between sites and sponsors, speeding up the startup process.
Regulatory Compliance Built-In
The platform is designed to ensure compliance with regulatory guidelines (ICH GCP E6) and electronic records regulations (21 CFR Part 11). Every action – from signing a 1572 to updating a protocol – is logged and auditable. Research staff spend less time on paperwork and follow-up and more on higher-value tasks like site coordination and patient engagement. Automated tracking saves time and improves accuracy by avoiding manual mistakes and document handling.
Effortless Study Log Management with COSMOS eDocs: Stay Compliant Without Extra Work
Clinical research sites face significant administrative burdens in maintaining accurate and up-to-date study logs. Maintaining records is time and resource consuming, and prone to errors, making compliance a constant challenge. COSMOS eDocs eliminates these inefficiencies by offering a fully automated electronic logging system. The study log files are automatically updates in real-time, ensuring compliance and audit readiness.