|
 |
|
|
Premier Research has a network of clinical research centers in the United States. Each of the centers has multiple experienced investigators and a full-time Premier Research staff that is highly trained and experienced. Our most recent FDA audit in September 2009 resulted in no substantial findings and no FDA 483 was issued. Our group of clinical research coordinators is comprised of over 50% licensed staff including registered nurses, licensed practical nurses, and emergency paramedics. Our clinical research coordinators have an average of four years experience in clinical trials. Our sites offer state-of-the-art recruiting and research facilities plus the ability to handle the most scientifically demanding trials in a range of therapeutic areas.
- Protocol Review
- Rapid Feasibility Assessments
- Informed Consent Form Development
- Source Document Development
- Rapid IRB Submission
- Rapid Subject Recruitment utilizing extensive subject databases
- Specimen Collection and Processing
- Data Collection using both paper CRF and eCRF
- Collection of Patient Reported Outcomes (PROs) using electronic and paper diaries
- Project Management
Our experience includes more than 700 in-patient and out-patient studies including:
Phase 1 Studies- Healthy Volunteer
- Proof-of-Concept Studies
- Dose-Ranging Studies
- Specialized Populations including oncology patients
Acute and Chronic Pains Studies- In-patient and Out-patient capabilities
- Proof-of-Concept Studies
- Pivotal Proof of Efficacy Studies
- PK and PD Studies
- Novel Pain Model Development
Phase 2-4 Studies in the following therapeutic areas:- Cardiovascular
- Dermatology
- Gastrointestinal
- Endocrine/Metabolic
- Infectious Disease
- Musculoskeletal
- Neurology
- Oncology
- Ophthalmology
- Psychiatry
- Respiratory
- Women’s Health
Our site management expertise allows studies to be up and running quickly, resulting in a multitude of significant benefits such as:
- Rapid Study Start-ups – With a centrally managed network employing consistent management practices, we can expedite the process of site selection, IRB interaction and approvals, regulatory documentation packages and budget/contract negotiation.
- Efficient Patient Recruitment and Scheduling – Our rapid telephone recruitment and screening system eliminates wasted time and effort and enhances enrollment of qualified patients. The location of our clinics in Arizona, Texas, and Utah makes it well situated for efficient recruitment. Each location has a diverse large population that includes a pool of students at nearby colleges.
- More Accurate Data – Patient testing and evaluation are vitally important in drug trials, especially in areas such as analgesia, where data is mainly derived from subjective reports. At the research centers, our personnel are trained in consistent evaluation and assessment techniques – leading to cleaner, clearer and more accurate data.
Each site is able to perform rapid, proof-of-concept, dose-ranging, single or multiple-dose studies, has private rooms, dormitory and extended stay capabilities, and can perform in-patient multiple- or single-day pharmacokinetic and pharmacodynamic studies. An overview of our facilities includes:
- Overnight stay capability
- 45 Phase 1 beds
- 28 cardiac telemetry units
- 45 dental beds
- 45 surgery beds
- 12 chair chemotherapy room
- Two quiet psychometry suites
- Access to 10+ million people
- Centralized call center
- PK sample storage
The Analgesia Model Development Team at Premier Research is highly experienced in the development and validation of novel models for analgesic research. The purpose of the Analgesia Development Program is to meet the challenges of present day drug development by developing models with a high degree of scientific validity that are also able to address such practical considerations as rapid recruitment and reduction in the signal-to-noise ratio. For example, the post-operative bunionectomy model developed by the team has reduced patient recruitment times by 30-40% using a small number of sites while providing assay sensitivity equal to or better than existing post-operative surgical models.
Other methodologies developed or refined by the Premier Research team include:
- Third molar extraction (wisdom teeth)
- Orthopedic/Podiatric surgery (bunionectomy and hammertoe surgery, knee arthroscopy, ACL repair, knee/hip replacement)
- General/Gynecologic surgery (hernia repair, cholecystectomy, hysterectomy)
- Pioneered Sciatic Block anesthesia techniques for bunionectomy
- Multi-day/Multiple dose designs for acute pain
- Dysmenorrhea repeated dose model
- Pre-surgical anxiety model
- Postoperative nausea & vomiting model
- Two stopwatch method for onset measures
To volunteer for a clinical study at one of the Clinical Research Centers, please click here.
|
|
 |
|