PRODUCT DEVELOPMENT SERVICES
Data Management and SAS Programming
ICON Development Solutions is able to customize its database services based on
clients' needs and preferred processes in all phases of clinical trials and
pre-clinical studies:
Develop databases based on clients’ Case Report Forms (CRFs) and specifications,
with full documentation
Transfer and verify all data from CRFs via double data entry, resolve all
discrepancies, and establish an audit trail by automatically tracking data
entries, changes and deletions
Ensure data quality and integrity through extensive validation checks
customized for each study
Load electronic clinical laboratory data into database and bioanalytical
data into PK databases
Code all Adverse Events, prior and concomitant medications to standard
dictionary terms
Change control and data security (e.g. encrypted electronic transfer)
enforced and monitored by strict control protocols
Standard SAS® programs to prepare tables and listings of
pharmacokinetic and clinical data from studies for preparation
of ICH-Compliant study reports and Integrated Summary of Safety (ISS)
and Integrated Summary of Efficacy (ISE)
