Dosing
Where First DosesBecome First Evidence.
A Phase I research facility where biotech sponsors bring their most promising molecules — and leave with clean data, intact timelines, and zero regulatory findings.
Dr. Rachel Okonkwo, MD PhD
Principal Investigator · 18 years FIH experience
Harvard Medical School · 127 Phase I trials completed
Four Voices. One Pattern.
Every sponsor, every volunteer, every biostatistician — they all describe the same thing: a facility where nothing is left to chance.
"We handed them a compound no one had dosed in a human being. Fourteen weeks later, the safety data was so clean our CMO read the topline twice just to make sure."
Diane Marchetti
VP Clinical Operations · Helix Therapeutics
Trial Context
A first-in-human SAD/MAD study for a CNS-active small molecule with a narrow therapeutic window and no prior human PK data.
The Challenge
Helix needed a site with deep neuro experience, telemetry capacity for overnight observation, and a PI who had personally managed CNS dose-escalation holds before.
The Outcome
All 6 cohorts dosed on schedule. One protocol deviation — caught internally, self-reported, closed before the FDA even asked. Final CSR delivered 11 days ahead of contract.
0
FDA Findings
Across 17 years and 214 trials
48
Inpatient Beds
6 dedicated clinical suites with 24/7 telemetry
23 days
Avg. Enrollment
Median time from site activation to first dose
214
Phase I Trials
FIH studies completed since 2009
"I've been a study volunteer for four trials here. The nurses remember your name. The PK draws are timed to the second. You never feel like a data point — you feel like the reason the work matters."
Marcus Webb
Phase I Study Volunteer · Participant since 2021
Trial Context
Marcus has participated in four separate Phase I studies at Dosing across oncology supportive care and metabolic disease programs.
The Challenge
High-quality Phase I data depends on volunteer retention and protocol adherence. Sites that treat participants as throughput see dropout rates above 18%.
The Outcome
Dosing's 3-year volunteer retention rate sits at 94%. Marcus has referred six friends. Zero SAEs across all four of his studies.
"The PK modeling came back with concentration-time curves so well-characterized that our biostatistics team had what they needed for the Phase II dose selection within 48 hours of the last sample."
Dr. Priya Sundaram
Senior Biostatistician · Quantile Clinical Analytics
Trial Context
A rare metabolic disease program requiring dense PK sampling across 12 timepoints per period, with samples requiring specialized handling at −80°C.
The Challenge
Timing variability of even 4 minutes on a dense PK schedule can introduce enough noise to require additional cohorts. Most sites accept ±10 minutes as standard.
The Outcome
Mean sampling deviation across 847 draws: 1.8 minutes. Zero samples outside the ±5 minute protocol window. The sponsor's modeling team called it "the cleanest Phase I dataset we've ever received."
1.8 min
Mean PK Deviation
Across 12,400+ pharmacokinetic draws
94%
Volunteer Retention
3-year average across all active protocols
11
Therapeutic Areas
Oncology · Neuro · Rare Disease · Metabolic · Cardio
<90 days
IND to First Dose
Median site activation timeline for new sponsors
Download Our Capabilities Deck
A detailed overview of our clinical suites, investigator team, regulatory track record, and Phase I service portfolio. No sales call required.
"I've reviewed the regulatory correspondence for eleven Phase I studies run at Dosing. The information requests are rare, the responses are surgical, and the inspection outcomes speak for themselves. This is what a low-risk CRO partnership looks like."
James Holloway
Regulatory Affairs Consultant · Apex Regulatory Group
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Our investigator team reviews every new inquiry personally. No intake forms sent to a call center — a real response from a real clinician.
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