Helping You Get Your Submissions Right!

Patients are waiting for your treatments and regulatory agencies want consistent data in recognised formats that follow industry standards. All helping you get to submission, and market, faster.

CentraLabS understands the need for clean data. A consistently exceptional database, delivered on time, is required every time you lock your database. Right from study start we take great care to understand your data management and data transfer needs for each specific protocol.

The results? Data Managers who understand your need for accurate and clean patient data. Providing you with complete data sets, in a flexible format that you define.

Features of our Data Management Services include;

• Use of fully integrated global data LIMS system to collect and clean data
• Single global database, standardised reference ranges, flags & panic alerts.
• Data consistency checks applied during sample accessioning allowing “real time” data cleaning.
• Final reports not issued until all inconsistencies are resolved.
• CDISC, HL7 and other standard data export protocol formats supported
• EDI exports in A
• SCI II , ODBC & SAS data sets available.

Regulatory Compliance

CentraLabS data collection and management systems are all deployed as part of a validated system that complies with GCP/GLP predicate rule requirements, laws, and regulations for clinical trial conduct and FDA 21 CFR 11 for electronic record and signature use.