This month, S-cubed’s Biometrics team, discusses how S-cubed can help companies that outsource Biometrics activities to a full-service CRO, and need additional support.

Supporting Biometrics activities on a clinical trial

In the role of a Consultant Statistician and/or Senior Data Manager, one of the activities we regularly get involved in is supporting clients who have already contracted out the full set of trial services to a full-service CRO, but have no in-house Statistician or Data Manager employed to review and approve Biometrics related activities which they are performing.

Statistical Support

For the statistical support, we in effect sit as their “company statistician” acting on their behalf (although ultimate responsibility still remains with the client), to carry out activities such as:

  • Statistical review of protocols
  • Blinded sample size review
  • Statistical analysis plans (SAPs) review
  • Blinded dry-run Tables, Figures and Listings (TFLs) review
  • Commenting on final unblinded outputs
  • Review of clinical study reports (CSRs).

Data Management Support

For data management support, our experienced Senior Data Managers can perform activities such as:

  • Data Management Plan (DMP) review
  • Data Validation Plan (DVP) review
  • eCRF review
  • Review of data validation checks
  • Database user acceptance testing

For both the Statistician and Data Manager roles we can work on behalf of the client to manage the CRO (liaising directly with their project manager) to assess timelines, discuss and resolve ongoing issues, and tracking data flow, data entry, data queries, etc. In addition, we can routinely attend data review meetings, and also regular project team meetings.

Additionally, if the full-service CRO is contracted to produce datasets in CDISC format (along with other CDISC deliverables, e.g. Define.xml, SDTM annotated CRF, reviewer’s guide) then we can provide a service whereby our S-cubed experienced CDISC programmers can review the CRO’s CDISC deliverables for compliance against the latest FDA standards.

Contact our Biometrics Team, if you require any further guidance or support.