In double blind studies, unblinding data or limited access data, such as randomization data, pharmacokinetic concentrations, laboratory and anti-body data, can cause delays in database lock and affect study timelines. Fully independent handling with a secure data office improves data quality, reduces study timelines and eliminates the risk of unblinding the study team.
Secured environment
Our highly skilled team of biostatistical SAS programmers and biomedical experts are supported by Oracle programmers. They operate in a secured environment that is authorized to manage all unblinding data. For each external transfer of information, a data transfer agreement will detail the agreements and variables.
Solutions cover:
- 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 and handling of blinded data before database lock
- Creation of cleaning transfers for data management by removing data of potentially unblinding nature from the lab data transfer.
- 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
Prior to database lock, we can also offer secure blinded and limited access data, as well as the cleaning of sample identifiers. Data is converted smoothly into the required Study Data Tabulation Model (SDTM) dataset structure.
Why choose secure data office from SGS?
We are recognized as the benchmark for quality and integrity in data management for clinical trials. Whatever your clinical trial requirements, our experts will support you with solutions that reduce risks and optimize outcomes.
