Our eTMF is designed for clinical professionals to support studies of any scale and is backed by a complete cloud-based document management system to structure studies’ document workflows. Real-time collaboration amongst Sponsors and CROs now becomes the new standard.
Complete study lifecycle
- Manage your documents and workflows from study start-up to study decommissioning.
- Boost your study by providing site administrators, sponsors, and CROs an online tool to create, store, view, edit, and collaborate on a TMF repository within a single – easy to use interface.
- Make your Site Files (ISF) talk to each other for real-time document access, review, and exchange. Transfer key documents from sponsor’s TMF to site’s ISF with a click.
- Share documents collected from Sponsor, CRO, sites and countries in a centralized repository for real-time access, review, and exchange.
- Perform quality checks automatically to find missing signoffs and missing documents.
- Keep your teams up to date with a document status tracker
- Stay in control by using granular profile-based access.
- Manage all documents in real-time to ensure compliance and audit readiness throughout the trial.
- Search and get access to all your documents without any hassle.
- Directly sign documents in the same app and be notified of any modification or any signature that is missing to complete the workflow.
- Save costs by increasing your filing efficiency, reducing paper, errors and impact of high workloads
Choose your essentials
Start with a simple configuration and easily scale to a full-service setup of your TMF.
|Base Document management system
||Quarantine protection for file uploads
|Minimum set of approval workflows
||Strict workflows to avoid missing steps
|Use of electronic signature
||Use of a full integrated digital signature solution
|Reminder system to alert for missing steps in workflows
|Use an essential reference model
||Mobile integration for managing/editing TMF documents on the go
||Complete DIA TMF reference model
||Integrated viewer for common file formats
- Compliant with CFR 21 Part 11, GDPR, and HIPAA regulations.
- Compliant with extensive audit trails, access control, lifecycle management and version control of clinical documents and records.
- Support for the Drug Information Association’s (DIA) TMF reference model.
Web-based interface natively cross-platform and device ready. Configurable role-based permission system.
ACTide eCRF provides your study team and site Investigators with all the required tools and services to succeed in their daily tasks plus the freedom of a Software as a Service:
- Online randomization (IWRS)
- Multi-laboratory normal ranges set up and management
- AE and SAE management
- SAE safety database
- Drug Management
- Online Medical Coding (MedDRA, WHO Drug Data Dictionary)
- Double Data Entry and reconciliation
- Monitoring tools eQuery management
- Query Builder for information retrieval
- KPI Dashboard
Drag & drop form builder. Reuse of study building objects & custom templates.
ACTide Designer is our powerful application to design, use, re-usu and deploy eCRFs and their requirements, including:
- Metadata definitions
- Visits, Sections, Entry-points
- Multi-purpose edit-checks: mandatory, visibility, consistency, warning
- Annotated CRF, study level validation templates
ACTide Designer is the ideal application to:
- Train your junior staff using an intuitive and easy-to-use interface.
- Build and share CRF template libraries between project management teams and clinical operations
- Native ePRO integration including email & SMS reminders
- Support for photo upload and phone-native functions
ACTide Clinical Data Management
- Real-time reports
- Data export to Excel, SAS, SPSS
ACTide Medical coding
- Integration with WHODrugs, MedDRA, others In-line and off-line coding service
ACTide Randomization & Trial Supply Management
- Randomization & advanced allocation
- Drug supply management & logistic with inventory control
- Live and backup EU hosted servers
- Encrypted communication
- One2One total support
- eLearning with online documentation and certification program
Our support team is composed of qualified professionals with a broad experience in developing eCRFs of any complexity and scale. It includes:
- Project Managers
- Clinical Data Managers
- Quality Assurance Managers