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.
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:
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.
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.
2nd Floor Alegria Office Building. 2229 Chino Roces Avenue,
1223,
Makati, Metro Manila, Philippines