Product Overview
The Electronic Investigator Site File (eISF) is a digital solution designed to help clinical trial sites organize and manage essential documents efficiently. It provides an intuitive and structured approach to ensuring that investigator site files comply with regulatory requirements while facilitating real-time collaboration between stakeholders.
- Site-Specific Document Management:
- Stores essential study documents required at the site level.
- Ensures that investigators have quick access to the latest study documents, including protocols, informed consent forms, and regulatory approvals.
- DIA Reference Model Compliance:
- Follows the Drug Information Association (DIA) reference model for site document organization.
- Ensures consistency in document classification and retrieval.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
- Customizable Study Configuration:
- Allows sites to configure document templates and track required submissions.
- Generates an expected document checklist to assist with compliance and monitoring.
- Regulatory Compliance and Inspection Readiness:
- Maintains an organized, audit-ready system for inspections from regulatory bodies.
- Supports document version control and timestamped electronic signatures.
- Secure, Remote Access and Collaboration:
- Provides cloud-based, role-based access to authorized personnel.
- Enables real-time updates and document sharing between sponsors, CROs, and site staff.
About the company
Telemedicine Technologies is the publisher of e-Health solutions, market leader in the field of Clinical Research with its CleanWeb™ solution, a secure Internet platform dedicated to the electronic management of clinical trials and registries.
By subscribing to our solution in SaaS mode or a project-based approach, you choose a flexible e-Platform and can opt for the applications and services: eCRF, CTMS, eTMF, eConsent, Medical Imaging, rSDV Monitoring, Vigilance, Randomisation, Managed Access Programmes (MAP) that you require… Our bespoke solution can be tailored to meet any clinical trial phase, size and complexity.
