PHASE I CENTER

MCRC offers a full service solution for Phase I trials in rheumatologic research. Our phase 1 unit was designed specifically to meet the unique, demanding structure of these trials. We are a niche provider in early phase research and offer the services that meet the unique and demanding requirements of first in human studies including pharmacokinetic, pharmacodynamics, bioequivalence and bioavailability.  At MCRC we minimize risk by ensuring the safety of study volunteers by

 

 

 

 

 

 

 

  • High clinician-to-volunteer ratio for dosing compliance
  • Time sensitive procedure compliance
  • Vigilant oversight of volunteers by highly trained ACLS staff
  • 24/7 physician coverage

 

 

With a focus on high performance, the safety and comfort of our patients and high quality standards, our phase 1 unit features an inpatient facility that includes a patient monitoring station, 12 orthopedically designed beds, private shower facilities, a large entertainment area with lush seating and a big screen television. wireless internet access, a dining and kitchenette area and catering services.

 

 

 

 

 

 

 

MCRC provides quick study start up and a quality finish for each project. Our strict quality standards produce accurate data, real time results with minimal queries and rapid regulatory response. To accommodate the needs of our Sponsors we offer the following services:

  • Dedicated Regulatory Staff
  • Certified and Experienced Coordinators
  • QA/QC Department
  • Board Certified Investigators
  • EDC Specialists
  • Dedicated Recruiters for rapid enrollment
  • Study participant tracking
  • Access to special populations
  • Dedicated Monitor space with wireless access
  • One week turn around for budgets and contracts

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MCRC Phase I experience includes:

  • Clinical Pharmacology Phases 1a and 1b
  • Early efficacy
  • Pharmacokinetic profiling
  • Proof of Concept
  • MAD/SAD
  • Drug/drug interaction
  • Healthy volunteers
  • First in human
  • First in disease
  • Bioavailability/bioequivalence

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MCRC Phase I Facility Provides:

  • Highly trained and experienced staff of Phase I EMTs, phlebotomists and Certified Coordinatiors
  • Temperature controlled drug storage
  • Pharmacy grade refrigerators and minus 80/20 freezers
  • On-site lab for processing and storing of samples
  • IV infusion preparation capability
  • Dietician services
  • Comfortable environment ensures high rate of study completion

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MCRC Accelerated Enrollment

To accelerate enrollment MCRC offers in-house recruitment and a large database of potential volunteers including special populations. Our partnership with Rheumatology Associates and our database aids us in providing:

  • Healthy volunteers
  • Ethnic diversity
  • Geriatrics
  • Patients with autoimmune disease

 

 

 

 

 

 

 

 

 

 

 

 

 

 

We also provide services for studies in Phases II – IV in many therapeutic areas including:

  • Rheumatoid arthritis
  • Osteoarthritis
  • Scleroderma
  • Sjogrens
  • Lupus
  • Psoriasis
  • Human factors/Device studies
  • Biomarker studies
  • Pain studies
  • Vaccines