Start your clinical trial database on the pathway to successful results with Biorasi. Our proactive strategy to data capture, monitoring, and cleaning gives your studies the edge over your competition by leveraging speed, agility, and quality.
Accomplish database build in 6 weeks or less
Biorasi is an industry leader in delivering premium quality databases with the flexibility of accelerated study builds. We follow a proactive, agile approach for designing databases by choosing design components from a centralized repository of CDISC and CDASH compliant standard CRFs, data dictionaries, code lists, derivations, and edit checks.
Our build speed is powered by data programmers and designers who are highly experienced and professionally certified in multiple industry-leading EDC platforms, practicing optimum utilization of the platform technologies and their features:
- Designing in a collaborative environment
- Promoting standards, best practices, and enforcement of design protocols
- Leveraging agility in developing high-standard study databases
This results in database builds that are 50 percent faster than the industry average – preventing obstacles and other bottlenecks and keeping your study up and running.
Complete database lock in 4 weeks or less
Biorasi begins planning for effective and efficient database locks early in the study by creating comprehensive data management and validation plans that ensure robust edit checks and manual checks. And, throughout the clinical trial, we relentlessly focus on real-time data collection, monitoring, and cleaning, and strategically triage data for systematic review. Below are just a few of strategies Biorasi deploys to enable the earliest quality data lock possible.
Real-time data cleaning
Data issues are spotted and addressed earlier, and queries are resolved in a timely manner, which means less burden on site staff and cleaner data
Batched data reconciliation
Data is triaged into batches which can be cleaned and reconciled long before the last patient out (LPI) milestone, enabling more efficient, rapid lock of the whole clinical database within a few weeks following LPI
Real-time alerts
Respond quickly to any trends or obstacles throughout your trial, giving you the flexibility to review data and make necessary corrections during the study execution, increasing data quality
These practices and others facilitate cleaning large amounts of data, earlier, resulting in CRFs being locked and signed earlier, streamlining the data workflow and delivering industry-leading results.
Achieve top-line results in 7 working days
Biorasi delivers top-line results faster by taking a proactive approach to your clinical trial data from day one. While many CROs wait until after database lock to compile and analyze study results, Biorasi gets hands-on with your data analysis from the point of data entry:
- Developing SDTM and ADaM deliverables during enrollment and treatment phases of the project
- Building TLF shells and setting up other data forms ahead of database lock
- Deploying rapid statistical analysis after database lock, shortening the steps to the successful standardization of your study data and final statistical analysis
Your top line results are oftentimes the most anticipated delivery milestone in the entire clinical study. Our statistical solutions are focused on streamlining the path to data readout so that you can get the results you need, faster.