Lab21 developed its sample and data management protocols and
infrastructure in the time-critical environment of the healthcare sector. The company has invested in industry standard applications and in ensuring that all data is stored in a secure managed environment. All Lab21 systems have comprehensive backup, recovery and contingency plans.

Lab21 IT and sample-handling systems adhere to ICH Good Clinical Laboratory Practice (GCLP) and College of American Pathologist (CAP) guidelines in addition to the specifications of the US FDA, as laid out in 21 CFR Part 11.

Each trial database is designed to meet the individual needs of the client. We export the data from our bespoke, secure database environment in a format that best suits the client’s receiving system, whether that is Oracle Clinical, Clintrial or SAS.

In addition to secure handling, storage and transfer of clinical data, Lab21 also provides on-demand status reports on any given parameter, secure online access to trial related reports and secure data warehousing.