We have experienced staff who are well-versed in the planning of clinical trials as well as the analysis of data. We can provide expertise for whatever level of support you need – including the ability to support the management of study data.
Review or author protocol sections with respect to statistical methodology and data management
Create randomization schedules.
Author protocol-specific Statistical Analysis Plans (SAPs) including creation of table shells and listings
Conduct analyses per the SAP using SAS
Provide interpretations from data analyses to be incorporated into reports or presentations
Creation of data management plan (DMP)
Tracking of regulatory documents
Creation of integrated payment rules and creation of check requests for site payment of enrollment or form completion
Working with study coordinators to assure scheduling of protocol-required follow-up visits
Reviewing data entry and assessing necessary database changes to fields and edit checks
Reviewing data and adding or closing queries per the protocol and DMP