Fast-track Route for first-in-patient Studies
Early phase Trials
What is it?
Early Phase Trials Platform
Developed to get to patients sooner, without an IND
Small 1-2 site trials in patients with safety and efficacy endpoints (sometimes with a dose-escalation arm)
10-30 patient studies with some safety and efficacy endpoints
What are the guidelines?
Safety and Regulatory Requirements
Goes through 3 regulatory bodies for approval (IRB, UHAP, COFEPRIS)
Designed with multiple stops for safety, DSMB heavy
Conducted under GCP regulations and ICH guidelines
For who is it?
Tailored for small/mid size startup biotech/pharma/device companies
Designed for riskier areas and exploratory ideas (neurosciences, implantable devices, etc.)
Fast fail/Success idea developed with venture capital input
What are the benefits?
Skip 1 Year / $2M – $4M USD Investing Just To Get To Patients
De-Risk Earlier / Fast Fail
IND Not Required With Valid Data for FDA Submission
Where are the trials conducted?
Location: Monterrey & Mexico City (MX)
Convenient Location – 200 Miles South of Houston
Large, Willing Patient Population due to strong patient-doctor relationship
US and local KOLs and regulatory experts to guide trial design
First-in-human data Faster
Platform developed to provide insight into safety and efficacy early, without consuming all small company’s resources.
It informs later trial for Phase II (endpoints, outcome selection). The studies are conducted with GCP, FDA compliant CRO oversight, so data can be used in the United States for filing purposes later.
Monitoring & Data Management
Safety & Protocol Writing
Therapeutic Area Expertise
We Will Help You Every Step Of The Way
Let’s Start the conversation