Life Sciences

HITRUST, or the Health Information Trust Alliance and integrates multiple regulations into a seamless framework.  With the integration of programs such as HIPPA, PCI and FTC (plus many more!) we can integrate platforms to handle many common issues with one implementation.

HIPAA keeps patient data private and secure.  Think of HIPPA like a top secret government secret distributed on a strict need-to-know basis – and you don’t need to know.  Those who do need to know are the doctors and practitioners treating and consulting with a patient.  Keeping the data safe until the right person opens the file.

FDA Pre-Cert is an up and coming program that will allow for communication and marketing of select pre-certified software based devices prior to final FDA approval.  This pre-certification is based on the premise that these elements are updates to

previously approved devices or considered low risk for failing FDA approval.

CFR 21 Part 11 takes all the current good manufacturing practice documentation standards and updates the regulations to allow for digital compliance.  From collecting the data as it occurs to traceability, storage and maintenance, we use Part 11 to make sure your team stays compliant while allowing you to adapt to the technological advances.

Clinical Trials are the culminating event of many life sciences lifecycles, bringing products, devices, treatments and drugs one step closer to sale and distribution.  Containing the data from research and development to the impact for treatment and side effects in patients, this data still has the ability to mold the development of life-saving treatments advancing our healthcare.