Data Management and Analysis
As industry standards evolve, Health Policy Associates has deftly responded to changing requirements and the changing needs of our clients. In addition to our regulatory and clinical experience, we have robust database management capabilities, including software development and a wide scope of data analysis services.
Database Development and Data Management
Health Policy Associates works with our clients to develop study-specific, customizable databases, and electronic data capture interfaces. Our services include:
- Customized database development and EDC system design in SDTM format with user acceptability testing and validation documentation
- Case Report Form design and CDISC-compliant annotated CRFs
- Customized training and EDC helpdesk for EDC users
- Real-time dashboard data overview
- Application design for QSR workflow analysis, CAPA management, clinical data, complaint handling, MDR reporting, and Part 11 compliance gap analysis
- Management of clinical data entered electronically by trial sites, through paper data entry at Health Policy Associates (double-entry and verification, or in combination)
- SAS-based query identification and resolution
Our team of SAS-certified programmers performs detailed statistical analyses using SAS version 9.3 or higher, including a priori analyses and ad hoc requests. We contract with top statisticians and biostatisticians as needed.
Our data analysis capabilities include:
- Developing and Executing Statistical Analysis Plans, identifying primary and secondary endpoints, and producing Tables, Figures, and Listings using appropriate statistical analyses
- Converting pre‑existing, noncompliant datasets into CDISC SDTM and ADaM formatted datasets for easy submission based on developing industry standards
- MedDRA and WHO Drug coding for Adverse Events, Medical Histories, and Concomitant Medications
- Writing and reviewing Clinical Summary Reports, presenting and defending data upon delivery, and providing support for FDA presentations and submissions (including panel meetings and PMA requests)
Proud Partner of MedNet Solutions
MedNet Solutions is a leading healthcare technology company specializing in electronic data solutions designed for the global life sciences community. MedNet’s proven, flexible and easy-to-use cloud-based eClinical systems dramatically improve the efficiency of clinical studies and registries of all types and sizes. Beyond simply electronic data capture (EDC), MedNet’s solutions deliver the tools and dashboards required to expertly manage all aspects of clinical research. Since 2001, pharmaceutical, medical device, biotechnology and Contract Research Organizations (CROs) around the world have trusted MedNet to consistently deliver the technology innovation, experience and reliability they need for success. For more information, please visit www.mednetstudy.com.