Blue Bell-based Pinnacle 21 is seeing demand for its services grow as companies rush to get new drugs and vaccines on the market due to the pandemic, writes Abby Lee Mosconi for the Technical.ly.
The company’s clinical data standardization platform streamlines the drug approval process and clears a more efficient path for getting life-saving drugs and medical devices to patients.
“All of the data our users gather is for proof that a new drug is doing what it is supposed to be doing,” said Bob Ganski, Pinnacle 21 principal software engineer. “The challenge is that the data being collected comes in many disparate formats from many different vendors.”
This is where the Pinnacle 21 platform comes into its own. It allows users to process the data points that arrive from clinical lab tests and patient questionnaires and prepare them for submission to the FDA and other regulatory agencies.
The company also makes sure to continuously optimize its process, such as adding “a new piece that requires vendors to more carefully validate their data before they send it to the pharma sponsoring the study,” said Ganski.
Read more about Pinnacle 21 at the Technical.ly by clicking here.