Milestone Regulatory Experts
MILESTONE shepherds your clinical research endeavors through the complex world of FDA regulations and GCP compliance. Whether you’re an academic sponsor-investigator, a clinical investigator conducting FDA-regulated research, or a small start-up looking to conduct commercial clinical trials, we will guide you step-by-step through every phase of the process, supporting your efforts toward achievement of every milestone. We bring experience and professionalism to every project and customize our collaborative support to your individual needs. With MILESTONE, you have an expert on call.
Contact
➤ LOCATION
St Petersburg, Florida
➤Email & PHONE
tcjarrell@milestoneregulatory.com
301.905.6702
Testimonial
“Milestone supported our organization’s recent pre-IND meeting with FDA. Che proved to be an invaluable asset in advising our team and compiling/submitting our FDA meeting request letter and meeting briefing package (and handling all correspondence with FDA as our designated regulatory representative). All project deliverables were submitted on-time, with the utmost attention to detail, and under budget.”
Latest News
November 2020: Gallia GL, Holdhoff M, Brem H, Joshi AD, Hann CL, Bai RY, Staedtke V, Blakeley JO, Sengupta S, Jarrell TC, Wollett J, Szajna K, Helie N, Mattox AK, Ye X, Rudek MA, Riggins GJ. Mebendazole and temozolomide in patients with newly diagnosed high-grade gliomas: results of a phase 1 clinical trial. Neurooncol Adv. 2020 Nov 12;3(1):vdaa154. doi: 10.1093/noajnl/vdaa154. PMID: 33506200; PMCID: PMC7817892.
January 2018: MILESTONE is now offering electronic submissions of eCTD-compliant US Investigational New Drug (IND) applications and Drug Master Files (DMFs) via the FDA's Electronic Submissions Gateway.
October 2017: A paired training curriculum and internal monitoring program for clinical research regulatory compliance in the emerging era of the single Institutional Review Board is published in the Journal of Clinical and Translational Science. (T. Che Jarrell, et al)