Services
| Biometrics
| Data Management
ORION’s
dedicated team of Data Managers, Data Coordinators and Data
Entry staff work in close collaboration with the Clinical Research,
Project Management and Pharmacovigilance teams. They work either
to our own in-house procedures or the client’s SOPs,
in full conformity with ICH.
Our internal Quality Assurance Department regularly audits the
Biometrics Department in the context of both System and Project
related audits.
Our services include:
-
Database
design and validation
-
Dictionary
set-up and coding
-
Programming
of edit checks
-
Development
of query resolution conventions
-
Independent
double data entry and reporting
-
QC
of database and database lock
-
Blind
review and reporting including ongoing safety table generation
if required
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