Services

XClinical offers MARVIN-related services ranging from full service set-up and operation of the system to complete technology transfer enabling sponsors to host and set-up MARVIN independently. Pick your required services from the following, non-exhaustive list:

Study set-up:

• Creation of e-CRFs, queries, sites, users and roles
• Set-up of online reports and data export routines
• Customization of enhanced requirements like randomization, drug accountability and logistics, data dictionaries and libraries
• Configuration of the separate patient identification database and laboratory data import modules

Data Management services:

• Study closure support incl. data exports for statistical analysis, SDTM transformation for submission, archiving of study data
• Set-up of ODM-SDTM mapping instructions
• Generation of SDTM datasets

Operations services:

• Full-service hosting, incl. Hardware and Software set-up, monitoring, backup, hot standby service etc.

Management support:

• Quality Management Support to adapt your SOPs for EDC trials or to perform study-specific validation
  Site selection and qualification
• Project management and support during study conduct
• Full technology transfer, including System installation and qualification, Technical Validation Services and System Administrator Training

Training & Support:

• Investigator, Monitor, Data Manager and Project Manager Training
• Hotline and email support

Of course, the above-mentioned set-up services always include testing and proper documentation.