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Good People Working on Good Projects with Good Process

Client Testimonials

“As experts in risk based monitoring, the Frestedt Inc team effectively negotiated a monitoring plan with our IRB to lift a hold on the study and manage a difficult site. Their risk based monitoring approach helped contain costs and get the study back on track for completion. I look forward to working with them again.”
– Humanetics Pharmaceuticals


“This group is a fantastic group to work with. They are extremely knowledgeable, diligent and professional.”
– Product Manager, medical device company

“I would recommend this group’s services due to their knowledge base, work ethic and professionalism.
– Product Manager, medical device company

“They [your competitor] took more time, and did not take as much responsibility for the project or content decisions. Your comfort with making decision and suggestions made working with you easier because we didn’t know what we wanted …that’s why we hired someone in the first place.”
– Manager of Clinical Operations, medical device company

“Really like the depth of knowledge, organization and ability to understand clients’ projects.”
– Anonymous response

“Frestedt was on time and within the target budget. Easy to work with.”
– Anonymous response

“Everything from the Frestedt group came in on time”
Senior Regulatory Affairs Specialist, medical device company

“Frestedt provides a dedicated resource throughout the process. I feel as though with RCRI/NAMSA/etc you will go through several different contacts with the need to reiterate and resend information. Having a singular point of contact is invaluable.”
Senior Regulatory Affairs Specialist, medical device company

Testimonials about Dr. Frestedt’s book
Warning Letters – 2016 Reference Guide:

“If I got a warning letter, I would hire you to fix it!”
– Director Clinical Affairs

 “This book will be a great tool for any company currently holding a warning letter.”

“I’ve seen a huge increase with more than 7 site inspections by FDA in the first 2 months of 2016. Sometimes the FDA inspectors are brand new and sometimes the trials have just started (less than 20 enrolled in large multi-year trials). This book will be amazingly helpful as I train my staff (and our sites) to be prepared for these ‘early intervention’ inspections.”

“Fantastic work on getting this book together… this is great information.”
– Director, Global Operations


Testimonials about Dr. Frestedt’s Seminars and Talks:

“I really enjoy and learned so much having Dr. Frestedt as the instructor.  She is very experienced and skilled person. I was delighted with the whole information and the easy way to teach it.”

“It is a very complete and up to date seminar.  Very useful for people working in Academic and company.”

 ”The instructor was one of the most gifted teachers I’ve ever had. She kept us on track while concurrently encouraging great interaction and tailoring the material towards the audience’s interests. She demonstrated great subject manner expertise, but used that to keep the course engaging and relevant rather than trying to show off how much she knows (which I’ve seen frequently elsewhere).”

 “Really good and knowledgeable instructor.  Excellent.”

“Excellent instructor, great expertise. It would be great if we have a little bit time, the contents is heavy and fruitful. 3 days would allow more breathing time to allow the team to digest and review the content. Overall great course, highly recommended. Thank you!”

“I have already sent an email to my colleagues to attend this course which is critical for our daily business. Great course!”