ABOUT US
Every trial needs total control of the data.
At TradeCraft, this belief drives everything we do — from how we structure datasets to how we guide sponsors through every phase of their clinical trials.
We know how important it is to feel comfortable and included each step of the way, while being guided by experts in the field. We apply the highest standards based on our long-term CDISC membership - and, our 100% on-shore teams, have a history of finding what others cannot.
Since our founding, we have had a 100% FDA submission accuracy (versus the industry average of below 85%). We get it right the first time as evident in our 0% rework requests. And, since rework directly correlates with costs, our process avoids the average industry of adding 15% in fees for additional work.
TradeCraft offers a regulatory submission acceptance guarantee.
History:
TradeCraft was founded by a statistical programmer who saw how sponsors lost control of their data—and the future of their trials—with large CROs. We built a team dedicated to one mission: To ensure our clients are never rejected by a regulatory agency
Our ability to guarantee submission hinges on our commitment to live out our core values:
-
Diligence in the Details
-
Commitment to the Craft
-
Proactive in Partnership
How We Work with Clients:
TradeCraft Clinical Research is a life sciences consulting firm providing expertise in the Statistical Programming and Biostatistics disciplines for life sciences organizations.
We specialize in the sponsor, becoming an extension of your team with expert biostatistics, programming, and proactive project management. Part of our proactive "value intrinsic" process includes an ever critical feedback loop where each step of our work (from deliverables, to data imports to data checks, to compliance, to stats review, and back again) continuously reviews and monitors data quality.
About Our Teams:
When it comes to statistical programming, we are the hands down experts in our area.
Our leadership board has nearly 100+ years combined experience in pharma. Our SAS programming staff have an average of over 15+ years regulatory experience (exceeding the industry average of 7-8 years) with continuous ICH/GCP and CDISC training. And, we maintain a CDISC Gold Member Status.
We do not replace your team. We augment it.
LEADERSHIP TEAM
Mike Willis
CEO & Founder
Brittaney Ortland
Vice President,
Project Management
John Ilgenfritz
Vice President, Biostatistics
As our CEO, Mike's focus has always been on keeping us accountable to our clients. His is a process-oriented leadership style that places ethics as our number one priority and follows it up with 22 years of experience in pharmaceuticals, a phenomenal set of technical skills, and a commitment to the exchange of ideas. He is also a PharmaVOICE 100 recipient! Contact
Brittaney is our Vice President of Project Management. Her collaborative approach, attention to detail, and understanding of our clients’ goals help us maintain speed and transparency across our portfolio of projects. Her adept planning methods and flexible management techniques help us deliver greater value to our clients every day.
With going on 30 years of experience in the field, John’s statistical analysis expertise in the planning, analysis, and interpretation of clinical trials is beyond comparison. He knows the industry and focuses on clients’ needs with pinpoint precision.
J. Kanan Sawyer, Ph.D.
Head of Communications and Marketing
Kanan was lured to return to our team after years with AWS, where she applied her decades of communication experience to cloud technologies. She has been a college professor, enterprise level keynote writer, author, researcher, and more.
Kristina Wriston, BSN, RN, CCRC
Senior VP of Business Development
Kristi has over two decades of experience driving innovation and operational excellence in clinical trial research. Kristina is able to leverage her robust background, that includes her work as a as a Sub-Investigator, Clinical Site Director of Operations, and a Registered Nurse to deeply understand sponsor needs and match them with TradeCraft services.