ethica has a dedicated department of Data Management experts that provide accurate, regulatory-compliant clinical data solutions. Regardless of whether your data are collected using:

• Paper 
• Facsimile
• Electronically (web-based or remote), or
• Interactive voice response (IVR) systems,

your data are always processed in an expedited manner.

Our data management services and procedures include:

• Data management plan (Quality Control Guidelines)
• Database design and validation plan
• Quality control testing of database
• Data entry (double)
• Data clarification, consistency/logic checks and querying
• Adverse event coding (MedDRA®)
• Concomitant Medication coding
• Central laboratory data import 
• Data lock, audit and export (SAS, ASCII, etc.).

Through our secure website, we are pleased to provide Sponsors with up-to-date tracking of a multitude of study parameters such as screening/enrollment status, CRF status, study medication inventory, Investigator payments, adverse events, primary/secondary outcomes, etc.

Our Data Management platforms are based on Oracle® Clinical™. All of our systems and software platforms are fully validated and comply with ICH Guidelines and current US and Canadian government regulations.