CRI Worldwide

• Services
• Phase I / Early Stage
  Clinical Services
• Inpatient Clinical Services
• End-to-end Clinical
  Research Services
• Patient Center
• Center for the Research
  of Pain Disorders
• Cognition Center
• The Pediatric Center
  of Excellence
• The Sleep Center

Critical Phase I Done Right

Careful study of advanced pharmaceuticals for client success

At CRI we believe in working closely with our sponsors throughout the drug trial process. Phase I research includes the initial introduction of an investigational new drug in people. We're here to anticipate the needs of our clients and patients. In these studies, physicians and research scientists closely monitor medically stable patients and/or healthy volunteer subjects. Most Phase I studies are designed to determine the metabolic and pharmacological actions of a drug or biologic in humans, any side effects with increasing doses and, if possible, to gain early evidence of effectiveness. We're trying to find what works. During Phase I, we gather sufficient information about the compounds' pharmacokinetics and pharmacological effects so we can design well-controlled, scientifically valid, Phase II studies. CRI works with sponsor partners to assist pharmaceutical and biotech companies in the design of a drug development plan that expedites the successful transition to Phase II proof of concept.

Constant care & monitoring capabilities

The people separate us from the rest when it comes to successful trials. The personal touch makes a difference when it comes to recruiting and retaining participants and generating effective results. Our boutique staff of diverse disciplines ensures quick and flexible responses to changing scenarios. With speedy medical reviews and filings, as well as ongoing record reviews, we are able to offer unparalleled attention to our patients and our clients. Reports are generated to demonstrate trends and to assess the need to change the process. We pay careful attention and are open to new directions. Constant review keeps us in the know. From the clinicians to the care staff, we are passionate about the role we are able to play in trial research. Clinical trials research is more than what we do. We are proud of the role we play in helping our sponsors, helping our patients, and ultimately helping humanity.

CRI Worldwide conducts both inpatient and outpatient Phase I clinical trials. Our inpatient facility allows significant pharmacokinetic testing, 24/7 patient monitoring, and the around-the-clock blood draws required for successful Phase I work. As needed, patients can be sequestered and monitored to ensure compliance with study-related restrictions such as food and beverage consumption as well as tobacco use, exercise, etc. Sequestered patients are monitored around the clock by our multi-disciplinary clinical team.

Unique range of study specialists

Conveniently located inside Lourdes Medical Center, a full service medical hospital, allows the CRI Phase I clinical research team broad coverage across the clinical specialties associated with Phase I clinical research. This diverse team of specialists comes together to conduct studies in order to better understand:

• ADME
• Bioequivalence / Bioavailability
• Cardiac Safety & QTc
• Dose Ranging & Maximum Tolerability
• Drug Interaction & Drug Metabolism
• Food Interaction
• EEG / ECG
• Mechanism of Action
• MRI
• PET Scanning
• Pharmacokinetics (PK)
• Pharmacodynamics (PD)
• Radio-labeling
• Safety & Efficacy Testing
• Smoking Control
• Structure-activity Relationships
• Surrogate Marker