Management: Your Data Becomes the Most Important Asset

In addition to managing the clinical study we can also provide full data management services to ensure the clinical trial generates accurate data in a compliant and timely fashion. Whether you have a small investigator-initiated study that needs data hosting and statistical support, or a large international multi-center study relying on remote data capture and robust analysis for inclusion in a PMA, our capabilities and commitment will help meet these challenges and assist in achieving your product development milestones.

Database Design. Our team works with you to design a unique database that mirrors your case report forms. Our streamlined database platform enables us to provide cost-effective solutions to data hosting needs with minimal start-up time. Throughout the study, we provide clients with real-time access to data as it suits their needs.

Query Resolution. Mistakes happen at clinical sites. This process is made visible so you are always aware of the status of your data, enabling improvement to the design and management of the clinical trial.

Part 11 Compliance. The value of data lies in its validity. From the moment our team receives your data, we ensure that all data management functions are performed in compliance with 21 CFR Part 11 governing electronic records. Whether double entered by our well-trained staff or entered on-site through electronic data capture, your data will be maintained in a secure database that is properly backed-up off-site.

Analyzing Data. Generating good quality data is only half of it. HPA Inc.’s statisticians will conduct the analysis you need to provide the timely results you want, all with an eye towards compliance. Whether it’s an interim analysis to check on the progress, or generating a final report for inclusion in a submission, we aggressively pursue results with an aim at providing a return on your clinical trial investment.

We understand that the key asset to your growth as a company is your clinical data. Our qualified professionals seek to consistently exceed expectations by providing datasets, conducting analysis and generating reports to maximize investments.