Research Center Profile:
Cardiology/Vascular Diseases
Premier Research Group is a dedicated clinical research center located in Austin, Texas. Dr. Stephen Daniels, the Executive Medical Director, oversees the center's experienced investigators, acts as a Principal Investigator on most studies and is well published in the analgesic research field. The site employs a highly trained and experienced staff. The most recent FDA audit in September 2009, which resulted in no substantial findings and no FDA 483 being issued, exemplifies an expertise of over 30 years in this rigorous and competitive area of clinical research.
Our clinical research coordinators are comprised of over 60 percent licensed staff including registered nurses, licensed practical nurses, and emergency paramedics. On average, our clinical research coordinators have eight years’ experience in clinical trials. The site offers state-of-the-art recruiting and research facilities plus the ability to handle the most scientifically demanding trials in a range of therapeutic areas.
Premier Research is dedicated to providing a full range of services that meet our client’s individual needs, whether based on the conduct of a single study or a series of studies. Services we offer include:
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
Access to Premier Research Group's CRO services
Number of Studies Conducted:
200+ Number of Studies Actually Completed:
200+ Number of Active Patients in the Database:
>14000 Regulatory Submission Turn-Around Time:
7 Business Day(s) Average Percent of Total Patients Randomized:
97% Average Percent of ‘Completed’ Studies that met Enrollment Goals:
97% EDC Capabilities:
Yes
Our experience includes more than 200+ in-patient and out-patient studies in the following phases and therapeutic areas:
Phase I
Phase II-IV
Acute Pain
Oral Surgery
Orthopedic Surgery
Bunionectomy
Knee arthroscopy
Hammer toe
Total hip replacement
Herniorrhaphy
Headache (migraine and tension)
Dysmenorrhea
Lower back pain
Chronic Pain
Osteoarthritis
Lower back pain
Device
Fever
Musculoskeletal Injury
Ophthalmology
Perioperative trials
Pre-op anxiety
Post-op nausea and vomiting
Restless Leg Syndrome
The research center, located on a city bus route, and within one mile of the University of Texas campus, has the capability to perform rapid, proof-of-concept, dose-ranging, and single or multiple dose studies. Within the facility are both private rooms and dormitory style accommodations that allow for extended-stay studies and for the performance of in-patient multiple- or single-day pharmacokinetic and pharmacodynamic studies.
In addition to the many impressive features listed below, the research center has a full time Executive Medical Director with over 18 years’ experience as a Principal Investigator. Plus we have access to the growing community of Austin, Texas and surrounding metropolitan area, as well as a steady supply of new incoming University students each school year.
Centralized Call Center
Overnight stay capability
18 hospital beds
24 non-hospital beds
Food preparation areas
Lounge and quiet areas
Showers
Equipment
10 cardiac telemetry units
PK sample storage and refrigerated centrifuges
24 hour temperature monitoring and alert notification system
Back-up generator
Pulse oximeters
ECG machines
On-site x-ray equipment
Operating room
Negative flow vent hood and compounding pharmacy
IV pumps
In addition, conference rooms and dedicated CRA offices make for a congenial and comfortable working environment for sponsor visitors and monitors.
Stephen E. Daniels, DO,
Dr. Daniels has more than 18 years of experience in the clinical research industry. Since joining Premier Research in 1997, he has served as Principal Investigator on more than 200 clinical trials in analgesia and general medicine. He provides medical guidance and serves as Medical Monitor on many of the clinical trials conducted at the Premier Research centers.
Prior to joining Premier Research, Dr. Daniels was the Medical Director at Research for Health, a large clinical research site in Houston, Texas, for three years. He also served as the Medical Director at RLC Healthcare Urgent Care Centers in the Greater Houston area for two years.
Dr. Daniels received his B.B.A. from Texas Wesleyan College, and his doctorate in osteopathic medicine from the University of North Texas Health Science Center in Fort Worth, Texas. He has professional associations and/or memberships in numerous professional societies including the American Academy of Family Physicians, the International Association for the Study of Pain, the American Society for Clinical Pharmacology and Therapeutics and the Drug Information Association. Over the past 14 years, Dr. Daniels has been the first author and/or co-author of more than 20 abstracts and publications in peer-reviewed medical journals.
Sub-Investigators
Permanent, full-time and part-time staff include registered nurses, licensed vocational nurses, paramedics, emergency medical technicians, clinical assistants, laboratory technicians and pharmacists.
All clinical staff are BLS certified with 50 percent also holding ACLS certification to ensure participant safety. In addition, 50 percent of our Clinical Research Coordinators are ACRP (CCRC) or SoCRA (CCRP) certified. Our research physicians who oversee the studies are board-certified and provide expert medical attention to study participants during a clinical trial. .
All of the site managers, study coordinators, patient recruitment specialists, and support personnel are Premier Research employees. They are specifically and extensively trained and know how to work efficiently to facilitate the conduct of your study.
Patient testing and evaluation are vitally important in drug trials, especially in areas such as analgesia, where data is mainly derived from subjective reports. Our personnel are trained in consistent evaluation and assessment techniques, leading to highly reliable and valid data for informed program decisions and subsequent submissions to various regulatory bodies. Our experienced clinical staff have used a multitude of eCRF and eDiary systems allowing them to accurately collect and enter study data with limited queries and excellent turnaround time..
We also have a comprehensive training program that involves new-hire and ongoing study-specific development at all levels. .
A proven Quality Assurance (QA) program minimizes site errors and allows for cleaner data. What we learn from internal QA audits is proactively applied to staff retraining. .
The city of Austin and surrounding metropolitan area records a population of over 1.7 million people with a widely diverse population. The University of Texas, located near the research center, has an annual enrollment of over 50,000, drawing students from across the nation and around the world. Austin's dynamic, sitting at the cutting edge of technology and research in many varied fields, lends itself perfectly to clinical research. The population is educated and informed regarding the benefits of all realms of research, including investigational drug and device trials.
In addition, with a database of over 14,000 subjects for both healthy studies and numerous other therapeutic indications, our research center has refined the process of subject recruitment through its extensive experience in recruiting clinical trials. The research center has a 97 percent enrollment rate (defined as the number of participants enrolled into a study divided by the contracted number). Other companies generate high volumes of potential participants but through targeted marketing and specific pre-screening performed by a centralized call center; our clinical research center recruitment department provides high quality evaluable subjects.
Our research center is well experienced with central IRBs. We are currently or have recently used the services of Sterling IRB, Schulman Associates IRB, IntegReview, Quorum IRB, and Copernicus IRB, to name a few. IRB selection is made by the research center if one is not pre-determined by the study sponsor. IRB submissions, consent form creation, and turnaround times are quick and handled by in-house personnel especially identified for this specific area of the research process.
Premier Research also has a dedicated clinical research center in Phoenix, Arizona:
Kyle Patrick, DO, Medical Director
Premier Research
Clinical Research Center
20414 North 27th Avenue, Suite 200
Phoenix, AZ 85027
(623) 815-9714
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the email form below. A representative from
the research center will then follow up with you.
