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Clinical Research Services

  • Trial feasibility and site selection
  • Regulatory document completion
  • Study design, planning and implementation
  • Patient recruitment and retention
  • General trial management
  • Investigational product management
At IMMUNOe we focus on offering the best services in Clinical Research. Our site requires 25% institutional overhead for the conduction of Clinical Research.

  • Study coordination
  • Principle investigator, CRC selection and training
  • IRB/ethics committee correspondence
  • Ministry of health/governmental approval
  • Customs clearance for investigational product

  • Efficient utilization of resources to meet market goals
  • Trial monitoring and close out activities
  • Data management/analysis
  • Electronic data capture (EDC) with FDA 21 CFR Part 11 adherence
  • Study reporting

Research Capabilities

With over 25 years of research experience and success in conducting clinical trials, IMMUNOe International Research Center has added a new full service facility specializing in both healthy and therapeutic trials.

The only early phase unit that combines an infusion center for biological compounds with a phase 1 unit. The only site that focuses on mechanism—immune-related.


We focus on all new biological therapies.


Phase I Unit Features:

 

  • Private Consenting Area
  • 2 Medical Examination Rooms
  • 1 Procedure Room
  • 2 Nursing Stations
  • Infusion Center: 10 private chairs
  • Living Area with 10 beds
  • Leisure Area
  • Showers, Bathrooms, Lockers
  • Kitchen, Dinning area
  • Laboratory: Draw and processing areas
  • Pharmacy: Laminar Flow Hood
  • Secure Storage

Equiptment
We have all the equipment required to satisfy Pharmacokinetic and Pharmacodynamic studies:

 

  • -70 freezer
  • -20 freezer
  • Refrigerators
  • Refrigerated Centrifuge
  • Centrifuges
  • Portable Oxygen
  • Crash Cart
  • Automated External Defibrillator
  • ECG Machines
  • Cardiac Monitors
  • Pulse Oxymetry
  • Back up Generator
  • High Speed Internet


  • Controlled research delivering high quality and rapid completion of all phases concerning drug trials
  • Full integration between medical/investigator and the administrative/monitoring diagnostic
  • A boutique early phase research facility
  • Infusion facility with trained infusion staff
  • A focus on immune-related disease
  • Ability to recruit patients through a large database and referral network
  • Multiple geographic locations for study implementation
  • Medical and research experience with a variety of FDA approved drugs and devices
  • Pharmacy includes laminar flow cabin, locked drug storage
  • Temperature controlled refrigerator, freezer and log system
  • Dedicated laboratory processing area
  • Centrifuge and calibration log
  • Separate rooms for screening potential subjects and the informed consent process
  • Close proximity to emergency services


Our Scope

  • Mild Asthma
  • Moderate Asthma
  • Severe Asthma

  • Allergic Rhinitis
  • Perennial Rhinitis
  • Eczema
  • Atopic Dermatitis

  • Eczema
  • Sinusitis
  • Atopic Dermatitis
  • Vaccination
  • Migraine
  • GERD
  • Otitis Media
  • Strep Throat
  • Other common childhood illnesses

  • H1N1
  • D-TAP
  • Meningococcal Vaccine
  • HPV
  • Flu

  • IVIG Studies
  • SCIG Studies

  • Autoimmune Related Disease
  • Inflammatory Bowel Syndrome
  • Lupus (SLE)
  • Rheumatoid Arthritis

  • Neuro-Immune Disease
  • Multiple Sclerosis
  • Neuropathy
  • ALS
  • Alzheimer’s Disease

  • ADHD
  • Depression
  • Autism
  • Schizophrenia
  • Bipolar Disorder

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