For Pharmaceutical and Medical Device Sponsors
Highly Scrutinised Data
Blood pressure is frequently used as a primary or secondary endpoint in both pharmaceutical and medical device clinical trials. Yet its variability and operational fragility make it one of the most scrutinised datasets in any submission.
Non-Standardised Protocols
Gaps in Audit Trails
Inconsistent Collection Methods
…all introduce regulatory risk, regardless of therapy outcomes.
Errors compound when blood pressure data is not validated at the point of capture. What begins as a site-level oversight can increase operational burden downstream and, in serious cases, compromise the integrity of the final dataset.
dabl’s Solution for Standardisation
dabl is a specialist solution for blood pressure endpoints and data completeness — a focus we have refined over 25 years across a wide range of pharmaceutical and medical device trial designs.
By helping sponsors standardise their blood pressure operations, dabl enables study teams to reduce operational burden, streamline timelines to database lock, and ensure their data is built to withstand regulatory scrutiny from the outset.
Tailored to the Specifics of Your Protocol
Every clinical study is unique, and dabl is designed to flex around your specific requirements. Our team works alongside yours from study start-up, configuring the dabl solution to accurately reflect your protocol and support your therapy endpoints.
Timing windows, blinding rules, validation and inclusion criteria, and role-based permissions are just some of the options available — all delivered through a user-friendly interface built for clinical environments.
Confidence in Data Accuracy
All data is validated at the point of capture to ensure accuracy and protocol compliance. Comprehensive audit trails record the who, what, when, and why of every action or change – providing a clear, defensible record of protocol adherence and data integrity throughout the trial lifecycle.
Flexible data export options ensure smooth, reliable transfer into your EDC of choice, with no manual reformatting or reconciliation required.
Reproducible Endpoints Through Standardisation
dabl provides a centralised collection point for blood pressure data across multiple sites, countries, and devices. Our systems are built for compliance and adhere to the local regulations of each of your site regions – giving you a single, complete source of truth for all raw blood pressure measurements, regardless of trial geography or scale.
Faster and Cleaner Trials
dabl offers live and on-demand training for site users, supporting fast study start-up with minimal friction. Our commitment to validated, complete datasets mean fewer blood pressure-related data queries and faster database locks.
The dabl system proactively flags BP-specific risk indicators including data completeness, variability, and outliers before results reach your EDC, reducing the burden on both site staff and data management teams throughout the trial.
Without dabl
Outcome
- Fragmented, unvalidated data
- High query volume at lock
- Delayed database lock
- Regulatory scrutiny risk
With dabl
Outcome
- Standardised, complete data
- Queries resolved at capture
- Faster database lock
- Audit-ready from day one