Data Management

The Data Management division is your partner for secure and efficient management of clinical study data across different study types and sizes. Its services include eCRF design, reporting and data visualization, data import and migration, support, change and user management.

Two clinical data management systems (REDCap® and secuTrial) and two service models are available:

  • Full Service: Complete database setup managed by our team (REDCap, secuTrial)
  • REDCap® Light: Study team implements database and manages everything around it. (available only to members of the University of Bern and its university hospital)

Training and continuous support are provided in all cases, along with access to learning resources and REDCap® implementation courses.

Overview

eCRF Design & DB Implementation and Reporting & Visualization

Full Service

 REDCap® Light

Reporting & Visualization

We set up your database in REDCap® or secuTrial.

You set up your database in REDCap®.*

Either we or you set up your database.

Includes:

  • ✓ Hosting, license, updates, backup, and maintenance of application and server

Upon costing agreement:

  • ✓ Setup and deployment of study database: eCRFs, randomization, edit-checks, visit stucture
  • ✓ Testing of study database
  • ✓ One-time initial system training, manuals
  • ✓ Management of users, roles and sites
  • ✓ Database closure and creation of archiving package

Includes:

  • ✓ Hosting, license, updates, backup, and maintenance of application and server
  • ✓ 2h course on REDCap® Database Implementation
  • ✓ Project creation
  • ✓ Templates and manuals
  • ✓ Standard role settings
  • ✓ Super user creation

Upon costing agreement:

  • ✓ Initial technical database review
  • ✓ Support during implementation
  • ✓ Randomization
  • ✓ and others

Upon costing agreement:

  • ✓ Descriptive statistics visualized in dashboards or customized reports in different formats (Markdown, Quarto, Shiny)
  • ✓ Data validation reports (Query reports)
  • ✓ Data imports including the analysis of source data, data preparation and quality check of imported data
  • ✓ Progress reports / Accrual plots
  • ✓ Support in data migration from our CDMS to yours or vice versa
  • ! *This service is only provided for members of Inselspital Bern or University of Bern.
  • ! We do not recommend REDCap Light for the following scenarios: blinded studies; studies exceeding the limit of 15'000 records; studies exceeding the limit of 5'000 fields.
  • ! Please refer to our terms and conditions for responsibilities.

Full Service

Full Service: we set up your database

Consulting & Contract

  • If needed, we discuss different solutions, systems and possible collaboration
  • You provide as many study details as available (e.g. synopsis, outline, protocol, CRFs, etc.)
  • We create a costing
  • You agree and we sign a contract

eCRF Design and Database Implementation

  • Timeframe: calculate 2-4 months
  • You provide specifications as complete as possible (e.g. final codebook, study protocol, variable listing, draft case report forms)
  • We draft and test the eCRFs, edit-checks and visit structure in active and close collaboration with you
  • You test and approve the study database as in-line with your specifications

Note: Many changes/new requirements during implementation/testing may have an impact on budget and timelines

Testing

  • Timeframe: calculate 2-4 weeks
  • we perform a final review and testing
  • we discuss all findings and final settings with you
  • we prepare last steps for deployment

Deployment

  • You provide us EC approval, a list of users and sites
  • We set study database productive
  • Your database is ready to include participants!

Changes

  • You inform us as soon as an amendment is planned
  • We might do a risk analysis, depending on the complexity of the change
  • We implement and test the change in close collaboration with you
  • You test and approve the change

Note: Changes/new requirements during data collection must be planned carefully, to ensure that no data are lost/changed. Many changes/new requirements may have an impact on budget and timelines.

User/Site Management

  • You inform us about any changes in user, sites, roles
  • We manage user rights and roles
  • We manage sites

Closure & Archiving

  • We perform accrual closure
  • We perform database closure and archiving
  • We provide you a ZIP-file containing data and meta-data

REDCap Light

REDCap Light: you set up your own database

Consulting & Contract

  • If needed, we discuss different solutions, systems and possible collaboration
  • If you need support, we create a costing
  • If you need support, you agree on the level of support and we sign a contract

eCRF Design and Database Implementation

 

Testing

  • You test your own database

Deployment

  • You finalise all user rights, roles, sites, etc.
  • You deploy your own database
  • We confirm deployment
  • Your database is ready to include participants!

Changes

  • You might do a risk analysis, depending on the complexity of the change
  • You implement and test the change

Note: Changes/new requirements during data collection must be planned carefully, in order to ensure that no data are lost/changed.

User/Site Management

  • We create new users
  • You manage user rights and roles
  • You manage sites

Closure & Archiving

  • You perform database closure and archiving
  • You inform us when your database is closed and archived

Data Visualization and Reporting

Our team provides a range of services tailored to meet your reporting and visualization needs.

What we offer:

Customized Reports

We create customized reports in various formats, such as Markdown, Quarto and others.

Descriptive Statistics Visualized in Dashboards

 Utilizing the Shiny tool, we transform descriptive statistics into interactive dashboards, allowing for easy interpretation and analysis of your data.
Data Imports We handle the entire process of data imports, from analyzing source data to preparing and quality-checking imported data, ensuring accuracy and reliability.
Data Validation Reports We generate data validation reports, including query reports, to identify and address any discrepancies or errors in your data.
Progress Reports Stay informed about the progress of your project with regular progress reports, keeping you up-to-date on key milestones and developments.
Accrual Plots Visualize participant accrual over time with our accrual plots, providing insights into study enrollment patterns.

Support for Data Migration

 Need assistance migrating data from our Clinical Data Management System (CDMS) to yours, or vice versa? Our team is here to help, ensuring a seamless transition with minimal disruption.