Here's what some of our clients have to say about us:
"I've worked with George DeMuth and Stat-Tech Services on 3 Premarket Approval Applications (PMAs) for first-of-a-kind medical devices. Each PMA was reviewed by an FDA Advisory Panel for which George gave the statistical presentation and addressed the Panel's questions. Each PMA was approved within a little over a year from the date it was first submitted. Our company has also worked with Stat-Tech Services on multiple Investigational Device Exemptions (IDEs) and major PMA Supplements. George not only knows the statistical methods that will be acceptable to FDA, he also knows many of the reviewers and statisticians at the Center for Devices and Radiological Health (CDRH). His communication and negotiation skills have been a real asset to our projects. Our continued partnership on many of our major projects is the highest form of praise I can give Stat-Tech Services."
-President & CEO, Regulatory and Clinical Services Consulting Company
"Two weeks before we were scheduled to file an electronic NDA, the FDA requested specially formatted patient profiles be added. We were concerned that our NDA would be delayed, however our Stat-Tech Services team told us they would finish the job on time. Not only did they finalize the patient profiles on time, but also provided a super package containing all bookmarks and hyperlinks. This was extremely convenient because it allowed us to "drop" the profiles right into our NDA. We greatly appreciate their hard work and optimistic attitude."
-Senior Director, Biostatistics, Pharmaceutical Company
"We needed to execute and document SAS programming validation for statistical analyses we conducted for multiple Phase I studies. Due to frequent and effective communication with our Stat-Tech Services team, we were able to successfully complete the project in the desired time frame."
-Director of Biostatistics, Pharmaceutical Company