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.
Chosen for nearly two dozen FDA data-integrity audits.
Built for inspections, not just enrollment.
Decades guiding high‑stakes medtech and biotech programs.
Health Policy Associates works with our clients to develop study-specific, customizable databases, and electronic data capture interfaces. Our services include:
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:
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)
When the stakes are high, HPA turns ambiguity into clear findings, prioritized risks and next steps, so your team stops debating in gray areas and starts moving with conviction.
HPA helps you make decisions and build evidence that holds up under FDA questioning—especially when data integrity, framing, or compliance concerns could derail your program.
Our senior-led team stays with you and manages scope changes transparently, so you avoid handoff drag, reduce rework, and control spend without the change-order spiral.
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.
You can find plenty of partners to run site visits, collect data, or assemble slides.
HPA is different: we are a senior‑led, FDA‑focused team built to help you:
And we do it all with a stable team and predictable budget.
If you’re carrying the pressure of an FDA setback, a critical submission, or a high‑risk trial, you don’t have to navigate it alone.
