Handling unblinding data requires specialized expertise. Our Secure Data Office is an independent group that is authorized to handle all data of potentially unblinding nature, such as randomization data, pharmacokinetic concentrations, and laboratory and anti-body data.
Why choose the SGS Secure Data Office?
We can provide:
- Handling of blinded (and limited access) data and cleaning of sample identifiers without the unblinding of the sponsor and project team. This leads to fewer inconsistencies and issues at time of database lock. The reconciliation of the sample identifiers is performed in collaboration with a data management department
- A smooth integration of the data before database lock by converting the bio-analytical data to the required database format and merging of the bio-analysis data with the clinical Study Data Tabulation Model (SDTM) data
- Fast turnaround in delivery of unblinded datasets to Data and Safety Monitoring Boards (DSMBs) or Independent Data Monitoring Committees (IDMCs)
- Trial efficiencies, including reduced reporting timelines by programming of the unblinding Non-Compartmental Analysis (NCA) and Non-linear Mixed-Effect Modeling (NONMEM) PK input files prior to database lock
The Industry’s Trusted Secure Data Office
Our team consists of biostatistical SAS programmers and biomedical experts supported by Oracle programmers who work in a separate and secured environment, which includes separate database and server folders with restricted access. These precautions guarantee that only the Secure Data Office team is able to access the unblinding data. This approach is supported by well-defined and strict procedures, describing in detail how the unblinding/limited access data will be handled and who is authorized to receive access.
Our services include:
- Creation, distribution and review of randomization lists
- Creation and distribution of code-breaking envelopes used for emergency unblinding at sites
- Storage of randomization lists until release at database lock
- Review of medication kit misallocation and drug dispensation pages
- Delivery of unblinded datasets in view of SUSAR reporting or emergency unblinding
- Set-up of transfer agreements with the bio-analytical lab (or with other blinded data providers) and handling of blinded data before database lock
- Creation of cleaning transfers by removing data of potentially unblinding nature from the lab data transfer. This allows data management to perform the reconciliation between sample identifiers of the lab data and CRF data prior to database lock without being unblinded
- Blinding of data to support pre-lock activities, such as biometric dry-run activities, interim PK calculations
- Set-up and programming of PK input files (NCA and NONMEM input files) before Database Lock
If you need information on how to handle unblinding data, our expert team will work closely with you to develop a tailored solution by:
- Defining study-specific blinding requirements and specifications
- Setting up a customized, secure data flow
- Deidentification of clinical data linked to biobank samples
To find out how our Secure Data Office can help you, contact us today.