Here's what some of our clients have to say about us:
"I have worked with George DeMuth since prior to his establishing Stat-Tech Services in the mid 1990's. I have worked with Stat-Tech Services on multiple studies since 2001. I have found Stat-Tech Services and its employees to be very knowledgeable and professional. Having recently submitted two PMA's within a 5 month period, I found George and his group to have been very thorough and responsive to requests that sometimes gave them very little time to respond. George is very experienced in the medical device area, something that is difficult to find in an industry heavily populated by very large drug studies, and his knowledge has proved invaluable in maximizing a positive response from FDA for our data presentations. I will definitely continue working with his company on future projects."
-VP Regulatory and Clinical Affairs of a Medical Device Company
"Our medical device company was in the middle of its first IDE study and planning a PMA submission in the near future. The CRO we were using for data analysis and reporting went out of business after our first interim analysis. We needed a CRO who could dive into the middle of our trial and perform 2 interim analyses and a final analysis. We chose Stat-Tech Services for three reasons: First, they have a considerable expertise in device trials where some CROs focus primarily on pharma and biotech studies. Second, we were confident that their quality processes were at or above those of any CRO. Finally, they have a proven track record of delivering statistics packages on time and within budget. Their high-quality deliverables and rapid production enabled us to file the PMA on time with great confidence in the results. We would not hesitate to work with Stat-Tech again in the future for statistical consulting and SAS programming."
-Sr. Director, Clinical Data Management & Biostatistics of a Medical Device 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
"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