BDLS provides specialist biometric services that cover all activities of data management, biostatistics, programming and medical writing. Our experienced project teams provide integrated, pragmatic solutions that are flexible, adaptable and generate high-value for our clients.
From database set-up, collection and monitoring through to analysis and reporting, BDLS biometric services collaborate to ensure data integrity is maintained throughout the clinical study life-cycle, by allowing data traceability and transparency in accordance with all data standards.
Our BDLS standardised libraries allow for the development of regulatory compliant, submission-ready packages. All BDLS teams are trained in Good Clinical Practice (GCP) and develop all projects in line with our standard operating procedures (SOPs) to ensure adherence to quality control processes and documentation of procedures and client SOPs
Since July 21st 2014, it has become mandatory for all sponsors to enable transparency by posting their clinical trial results in the European Clinical Trials (EudraCT) Database, managed by the European Medicines Agency (EMA).
To ensure compliance with regulatory standards, BDLS has developed a wide range of industry-leading solutions to assist clients with entering clinical trial summary results into the EudraCT Database. Our processes reduce backlog and aid in the development of processes for ongoing studies, including the provision of general consultancy advice, requirements and the technical aspects of these requirements.
De-identification of data
Following the introduction of Policy 0070, it has become critical to ensure patient privacy without limiting access to patient data. At BDLS, we understand the balance between the usability of propriety clinical data and protecting patient privacy and apply the principle of 7 PhUSE de-identification methods across all clinical trial data. This consists of three steps:
- Assessing the role of each variable by determining its identification potential, quasi and direct identifiers across all datasets;
- Assigning primary and alternative rules for de-identification;
- Understanding all rationale and addressing exceptions and special considerations.
BDLS also provides a residual risk analysis that provides evidence to regulators that the risk of specific data re-identification is low and allows for the release of highly granular data.