IMMUNOe 1st International Research Centers’
global perspective is unique in its capacity to
manage clinical trial operations for both pharmaceutical
and investigator-initiated research studies.
IMMUNOe 1st International Research Centers
delivers data in a timely fashion with the highest
and most consistent quality from each of our
research sites, offering the best solutions for
small and early phase studies.
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
- 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
We provide large and small pharmaceutical and CRO companies the following advantages:
- Cost-effectiveness
- Broad site selections
- Superb company-wide quality assurance
- Rapid turnaround
PHASE I–IV RESEARCH CAPACITY
Our qualified staff of project managers, principle
investigators, clinical trial coordinators, regulatory
specialists, pharmacists and quality control experts
has successfully completed Phase I–IV clinical research
trials in the United States, Latin America and Europe.
We offer all aspects of clinical research:
- Controlled research delivering high quality and rapid completion of all phases concerning drug trials
- Full integration between medical/investigator and the administrative/monitoring diagnostic
- An infrastructure for early phase research
- 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
