Life Sciences

SageKey Software specializes in medical software development

We have been building software applications for the life sciences industry since 2001. We've completed a wide range of projects to high standards of quality and customer satisfaction.

We are not an ordinary company and we do not create ordinary results. Some of the things that set us apart are the quality of our developers, a fully audited manufacturing process and the company infrastructure required to create software for FDA regulated applications such as clinical trials and electronic health records.

We have a track record of creating exceptional software for our clients. We set high standards for ourselves and have a reputation for building great working relationships with our clients and their end users which allows us to design better software. We are results oriented and use a nimble, proactive approach to software development that balances rapid development and creativity with the documentation and process required of FDA compliant software.

Developing custom medical software that complies with FDA standards is a specific, provable, auditable set of skills, procedures and infrastructure that only a few custom software companies possess. We have this capability and we have passed independent audits that prove it. We welcome you to visit us and conduct your own audit of our methodologies, capabilities, standard operating procedures and infrastructure.

Some examples of our work for clients are:

A full EMR for dialysis clinics built to FDA standards, that manages all patient data and includes interfaces for lab results and a direct data feed from the dialysis machines.
A cardiovascular outcomes research data gathering program installed in over 200 clinics.
An economic modeling program used to analyze the total costs to the healthcare system associated with introducing a new drug or technique into an existing healthcare environment.
Over a dozen marketing tools that show the economic impact on total healthcare costs of using one drug verses another.
An outcomes data gathering tool designed for use on PDAs.

HITECH Act

Industry experts estimate that 60% of the medical software in use within the United States today is not compliant with HIPAA and FDA regulations.

The Health Information Technology for Economic and Clinical Health Act introduced in 2009 increases the enforcement of HIPAA and FDA regulations...

FDA

21 CFR Part 11 is the FDA Regulation that set the standards for Electronic Medical Data.

Part 820 defines the manufacturing process required for FDA regulated environments.

Building software to FDA standards ...

HIPAA

The Health Insurance Portability and Accountability Act protects the privacy of patient data.

Software that contains patient data is required to have specific features that protect this data from misuse...