Discuss Your Study

Phase I / Early Phase

140 Phase I Beds.
Two Dedicated Units.
One Integrated Operation.

Dedicated early-phase infrastructure for studies where dosing, monitoring, sampling and execution have to stay tightly coordinated—from First-in-Human through early proof of concept.

Discuss an Early-Phase Study Explore Capabilities

Built for early-phase execution

Capacity matters. So does what happens around every bed.

Core’s units are dedicated to early-phase research—not general clinic space shared between studies. The platform combines protocol-specific study capability with the monitoring, sample-processing and dosing infrastructure required for tightly controlled execution.

Study Capabilities

First dose → early PoC
FIH First-in-Human Programs entering human studies for the first time.
SAD / MAD Ascending Dose Single- and multiple-ascending-dose protocols and cohort escalation.
PK / PD Pharmacokinetics & Pharmacodynamics Intensive protocol-defined sampling supported by on-site PK processing.
BA / BE Bioavailability & Bioequivalence Comparative pharmacokinetic study designs.
Food Effect Fed / Fasted Designs Protocol-defined food-effect study execution.
Early PoC Early Proof of Concept Studies informing the next development decision.

Execution Infrastructure

Verified capabilities
01
Dedicated Early-Phase Environment

Two units dedicated to early-phase research.

02
Cardiac Telemetry & Monitoring

Infrastructure supporting protocols with intensive cardiac and safety-observation requirements.

03
On-Site PK Sample Processing

Supports time-sensitive specimen workflows required by pharmacokinetic protocols.

04
Overnight & Staggered Dosing

Capacity for overnight stays, staggered dosing and intensive timepoint schedules.

One integrated operation

Two units. One Core relationship.

Core’s Phase I capability sits inside the same clinical trial execution model as the broader Core network—giving sponsors and CROs a centralized operating relationship without blurring sponsor oversight.

Core Coordinates

  • Feasibility and unit fit
  • Startup and activation
  • Contracting and budgets
  • Study-level operational coordination
  • Protocol execution at the unit
  • Performance visibility and escalation

Sponsor / CRO Retains

  • Study-level strategy and oversight
  • Monitoring
  • Data management
  • Medical monitoring
  • Sponsor governance and decision-making
The operating model consolidates.
Sponsor visibility does not.

And when development moves beyond the unit, Core can evaluate protocol-matched community and specialty investigators through the same coordinated organization.

Clinical Operations

Bring us your early-phase program.

Share the synopsis or protocol. Core Clinical Operations will assess the study against available early-phase capacity, unit capabilities and the broader execution needs of the program.

Discuss Your Early-Phase Study Call Clinical Operations 561-765-7673

Have confidential study information to share? Core can execute an NDA before receiving your protocol, synopsis or other confidential study materials.