SERVICES

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Data management

• Data Management Plan (DMP), Data Validation Plan (DVP)

• Database design

• Development of EDC tools (customized web-based tools and surveys)

• Annotated CRF

• Data collection, CRF tracking

• Data entry, data cleaning, data aggregation, data exports

• Users management

• Training and user support

• Discrepancy management

• Medical coding

• Database locking

• Hosting

 

Software development & Testing

• Web Solutions

• Desktop and Server Solution

• Mobile Solutions

• Validation & Software Testing

 

IT Services

We perform for you the following tasks:

• Software installations and upgrades

• Migration projects

• Network administration and audit

• System administration

• Operating systems installation and configuration

• Work station installation and administration

• Local or remote server’s administration

• Firewall installation

• Data back-up

 

QA/QC & Validation

TherAxess’ consultants and partners have been involved in various IT systems implementation and software validation for the pharmaceutical and non-pharmaceutical industry.

We combine the extensive knowledge of risk-based validation approach and the best practices in the pharmaceutical or non-pharmaceutical.

• QMS definition – preparation of SOPs, FORMs, GUIs

• Computerized system validation

• IT infrastructure qualification

• Project management

• Change management

• Supplier assessment