Planning & Charter Input
Statistical roles, data cuts, output scope, review cadence and decision-rule requirements.
INDEPENDENT REVIEW SUPPORT
DMC / DSMB Statistical Support
Statistical programming and reporting support for independent data review. The exact TUNECT role follows the study charter, independence model, blinded/unblinded access rules and sponsor governance.
SCOPE
From Charter to Controlled Review Package
Interim Data Preparation
Controlled data snapshots, derivations and programmed review outputs for the defined review cycle.
Open / Closed Session Outputs
Materials aligned with approved shells and the charter-defined audience for each session.
Independence, Blinding & Access Control
Role separation, restricted unblinded access, documented permissions and controlled transfer/storage boundaries where required.
QC & Validation
Independent or targeted checks for critical derivations, tables, figures and cross-output consistency.
Meeting & Follow-Up Support
Statistical support for questions, versioned updates and controlled post-meeting actions where in scope.
WORKFLOW
Controlled Review Cycle
01
Charter & Roles
02
Access Setup
03
Data Cut
04
Program & QC
05
Open / Closed Package
06
Meeting & Follow-Up