Services >> Clinical Data Management

.........................................................................................................................................................................................................................................................................

Roxaane's Data Management team comprises of Data Managers, Quality Review personnel, Database administrators, Clinical programmers and Medical Coders. They have considerable experience having managed several projects for several Pharmaceutical and Biotech companies for Phase I to IV clinical trials

Roxaane's staff has several years of experience in Oracle Clinical for Paper studies and also in industry standard Electronic Data Capture systems. Medical Coding will be done by appropriately trained Medical personnel. All personnel are extensively trained in 21 CFR Part 11, ICH GCP, CDISC, relevant SOP's and functional training.

Roxaane's infrastructure includes Oracle Clinical Data Management System, MedDRA and WHODRUG for Coding, Crystal reports for report generation, WinNonlin for Pharmacokinetic Analysis. We also provide services for any client specific CDMS on an ASP model

Production servers will be hosted at a Level III data centre with redundant IT infrastructure like power and internet connectivity, regular scheduled backups and disaster recovery. This facility has been audited by several customers with no findings

Roxaane is well equipped with physical as well as electronic access control measures viz. biometric access controlled Central Archival room for CRFs and study documents, off-site storage of back-up tapes and CDs, as well as daily/weekly/monthly back-ups

Roxaane's services include

Intelligent CRF designing to capture Data based on Protocol

Robust database design and set up

Effective Validations for a smooth database closure

Meticulous manual review of data

Medical coding by appropriately trained medical personnel

Scheduled report generation to get a feel for Data quality