Local lab data management

Local laboratories are labs commonly on-site or close to the investigator site, and they are often utilized in a clinical trial when data is needed immediately for treatment or randomization.

When a clinical trial requires local or point-of-care laboratory testing, managing the resulting data can be a significant burden to a sponsor and the investigator sites. There are several factors driving the need for local labs: laboratory reports vary greatly across the globe; remote laboratories and investigator sites may not have IT support; and point of care testing can involve remote testing or satellite lab testing at or near a patient. The number of local labs needed will vary by study: for instance, it is estimated that a late phase study might utilize >500 local laboratories.

Some lab data challenges include multiple vendor usage, additional site burden and consistency issues. Therefore, managing local labs can require extensive Clinical Trial Management and sponsor oversight. The local lab data manager reviews and addresses issues reported in reconciliation logs sent by the sponsor or CRO to address inconsistency of reported data in two different databases. Additionally, we offer services to convert central lab studies to local labs permanently or temporarily —as is the case of the current pandemic— to assure continuity of data reporting.