CTMS eTMF and EDC for Clinical Investigations

Clinical Trial Management System (CTMS)

BSI CTMS is the backbone of your future clinical trial management. Plan, track and monitor all your pre- and post-market studies with complete oversight of all study relevant data in one system due to the seamless integration with SMART-TRIAL EDC.

Study design and study setup based on templates
Local, regional and global studies
Site and principal investigator (PI) data base
Study and site budgets
Milestones and activities
Risk based site monitoring
Offline monitoring
Tracking of risks, issues, protocol deviations and (SAEs)
Risk based site contract and invoice tracking
Tracking of complete study communication (e-mail, phone, calls, letters...)

Electronic Trial Master File (eTMF)

BSI eTMF delivers comprehensive functionality for all aspects of trial master file management for your clinical trials from study startup, to execution, flexible reporting and closing.

Full support of your own TMF structure or the TMF Reference Model from DIA with controlled access for all study partners e.g. sponsors, CRO and sites. Setup document plans and track the creation, reviewing and approval process with enhanced alerting functions. Perform regular quality control of all study documents.

TMF reference model from DIA
Document plans with automatic creation of placeholders
Work on, upload, link, and save documents and e-mails
Review and approval workflows including electronic signatures
Document deadlines with alerting functions
Download complete eTMF with optional PDF/A conversion

Five Ways a MedTech eClinical Suite Helps with MDR/IVDR Compliance

The need for electronic data capture and eClinical Suite solutions is vastly increasing as the MDR & IVDR deadlines are approaching.
But how can an eClinical Suite help MedTech companies ensure simplified and compliant clinical data gathering and management?

1. Validated Software with Compliance Templates
2. MedTech Know-How and Experience
3. European Data Protection
4. Mirroring Industry Needs
5. Empowering Clinical Teams

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Combine SMART-TRIAL EDC with CTMS and eTMF for Clinical Investigations from BSI

Clinical Trial Management System (CTMS)

Study design and study setup based on templates

Local, regional and global studies

Site and principal investigator (PI) data base

Study and site budgets

Milestones and activities

Risk based site monitoring

Offline monitoring

Tracking of risks, issues, protocol deviations and (SAEs)

Risk based site contract and invoice tracking

Tracking of complete study communication (e-mail, phone, calls, letters...)

Electronic Trial Master File (eTMF)

TMF reference model from DIA

Document plans with automatic creation of placeholders

Work on, upload, link, and save documents and e-mails

Review and approval workflows including electronic signatures

Document deadlines with alerting functions

Download complete eTMF with optional PDF/A conversion

Five Ways a MedTech eClinical Suite Helps with MDR/IVDR Compliance

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