Clinical Research Services is a department within St. Alexius Medical Center fully dedicated to providing research support services to physicians within our region and the valued patients they serve. St. Alexius Medical Center is a tertiary care facility affiliated with PrimeCare, a network that includes over 150 physicians both in private and institutional practice. We have been conducting clinical trials for over 25 years. This collaboration between our experienced investigators and highly motivated clinical research team allows us to offer the latest research medicines and treatments to our patients along with the highest quality service to our patients and sponsors.

Our office consists of 6 full-time/1 part-time employees and provides comprehensive research services and personalized care to research patients 24 hours a day, seven days a week (in addition, 9 clinical pharmacists with residency training have extensive experience as study coordinators). Responsibilities of our dedicated staff include placement of studies with appropriate investigators, regulatory and IRB document submission, study tracking, finalizing contracts and budgets, patient recruitment, providing study coordination and completing case report forms.

Careful precautions are taken to ensure the protection of our study participant’s rights and welfare. Participants are kept informed throughout the course of their participation in a clinical trial.

Mission:
The mission of Clinical Research Services is to advance the future of medicine by providing research opportunities for participants, physicians, our community and sponsor organizations. Our comprehensive clinical expertise, innovative approach and high quality are demonstrated by fostering relationships through integrity, teamwork, and excellent customer service.

Vision:
The vision of Clinical Research Services is to be a leading investigative site contributing to the research of groundbreaking medication and future technologies by ensuring accuracy, timeliness, and dependability. This vision supports continuing research endeavors with numerous sponsors, physician investigators, and clinical research organizations.

Clinical Research Services has been involved in clinical research since 1987. Our professional staff has over 160 years of combined experience in clinical trials.

Our involvement in inpatient and outpatient phase II-IV clinical research studies has contributed substantially to the development of new drugs and treatments for the following conditions:

Angina Asthma Cancer: bladder, breast, colon, lung, melanoma, chemo-induced nausea, neutropenia, prostate, brain, pain, multiple myeloma, cachexia Chronic pain Chronic obstructive pulmonary disease (COPD) Community acquired pneumonia Conjuctivitis Coronary artery disease Cystic fibrosis Depression Diabetes - Adult/Pediatric Dupuytren’s Contracture Dyslipidemia Early stage severe sepsis Endometriosis End-stage renal disease Erosive Esophagitis Gastroparesis GERD (Gastroesophageal Reflux Disease) Heartburn Hormone Replacement Therapy Hyperlipidemia Hypertension Incontinence Infectious diseases

Influenza Insomnia Irritable bowel syndrome Mennorrhagia Men's Health Migraine-- adult and pediatric Multiple Sclerosis Myocardial infarction Spinal cord injury Non-Hodgkin’s lymphoma Obesity Orthopedic Conditions Osteoarthritis Osteoporosis Overactive bladder Peptic ulcer disease Post-surgical pain Prevention post-op ileus Rheumatoid arthritis Schizophrenia Sinusitis Stress Urinary Incontinence Stroke Ulcerative Colitis Weight Reduction Women's Health Sleep Apnea Fibromyalgia

Our clinical research team is committed to providing:

• Rapid study start-up
• Pro-active patient enrollment
• Clean data submission
• Highly experienced principal investigators
• Initial training and continuing education for all support personnel

Our reputation for accuracy, timeliness, and dependability stands above the rest as evident by our repeated research endeavors with SPONSORS and CRO’S such as:

Abbott Laboratories Acorda Therapeutics Adolor Corporation Alcon Allos Therapeutics, Inc Amgen, Inc. Arena Pharmaceuticals, Inc. Ark Therapeutics, LTD AstraZeneca Auxilium Pharmaceuticals, Inc. Aventis Bayer HealthCare Pharmaceuticals, Inc. BioCryst Pharmaceuticals, Inc. Biomira, Inc. Boehringer Ingelheim Bristol-Myers Squibb Cell Therapeutics, Inc. Cephalon DePuy Spine, Inc Eli Lilly & Co. Endo Pharmaceuticals Forest Research Institute Genentech, Inc. GlaxoSmithKline Janssen Pharmaceuticals Lorex Pharmaceuticals Luitpold Pharmaceuticals, Inc. Maxim Pharmaceuticals Merck & Co. Microbia, Inc.

Millennium Pharmaceuticals, Inc Mucos Neurocrine Biosciences, Inc. Neurocrine Biosciences Novartis Novo Nordisk OSI Pharmaceuticals, Inc. Organon, Inc Pfizer Inc Proctor & Gamble Purdue-Pharma Rib-X Pharmaceuticals, Inc. R.W. Johnson Research Institute Roche Laboratories Sanofi-Aventis Sanofi-Synthelabo Searle & Co. Serenex, Inc. Shire Development, Inc. SkyePharma SmithKline Beecham Sucampo Pharmaceuticals, Inc. TAP Pharmaceutical Products Inc. Tioga Pharmaceuticals Tranzyme, Inc. Vical, Inc. Vivus Wyeth Xanodyne Pharmaceuticals,Inc.

CLINICAL RESEARCH ORGANIZATIONS:

Akzo Nobel Biopharm Cell Therapeutics, Inc Chiltern International Inc. Clinical Research Group Clintrials Covance CTMS DP Clinical GH Besselaar Associates IBRD ICON INC Research Innovex Inveresk Research Kendle International LBR Regulatory

Medici Group Medpace Med Search, Inc. MedSource Millenix MTRA Omnicare Paragon Biomedical, Inc. PAREXEL PharmalinkFHI PPD Development PRA International PRN Quintiles Target Research Associates The Freeman Group United BioSource Corporation

Clinical Research Services offers a professional atmosphere for our research patients and monitors. We are also equipped with a patient waiting room, complete exam rooms, a phlebotomy station with processing capabilities, and a secured area for investigational drug storage. We provide a dedicated room for our monitors complete with phone and computer accessibility. This room has its own separate access so that our monitors can work even when our main office is closed. We also provide wireless internet access.

As a department within St. Alexius Medical Center, a Level II Trauma Center with 308 licensed beds, Clinical Research Services is centered among nine multi-specialty clinics. The medical complex is equipped with CT, MRI, Hologic DEXA scanners, a state-of-the-art radiotherapy Cancer Care Center, an outpatient hemodialysis and peritoneal dialysis center, and regional laboratory services. It also has full electrophysiologic and interventional cardiology labs. St. Alexius Medical Center and affiliated clinics have a large database accessible by ICD-9 diagnostic codes.

Clinical Research Services is also easily accessible by public transportation. We are only 10 minutes from Bismarck International Airport, which is served by two major airlines via Minneapolis and Denver.

• John Windsor, DO
  Area of Expertise: Cardiology/Interventional Cardiology

• Gordon Leingang, DO
  Area of Expertise: Emergency Medicine

• Bilal Ahmed, MD
  Area of Expertise: Endocrinology

• Jeffrey Orchard, MD
  Area of Expertise: Family Medicine

• Shelly Seifert, MD
  Area of Expertise: Family Medicine

• Dr. Shelley Killen, MD
  Area of Expertise: Physical Medicine and Rehabilitation

• Steven Scherr, MD
  Area of Expertise: Family Medicine

• Bipinkumar Amin, MD
  Area of Expertise: Hematology/Oncology

• M. Roy Thomas, MD
  Area of Expertise: Hematology/Oncology

• Robert Tanous, DO
  Area of Expertise: Internal Medicine

• Earl Dunnigan, MD
  Area of Expertise: Nephrology

• Ralph T. Dunnigan, MD
  Area of Expertise: Neurology

• Syed Hyder, MD
  Area of Expertise: Neurology

• Chatree Wongjirad, MD
  Area of Expertise: Neurology

• Robert Bury, MD
  Area of Expertise: Obstetrics/Gynecology

• John Witt, MD
  Area of Expertise: Obstetrics/Gynecology

• Jerry Obritsch, MD
  Area of Expertise: Obstetrics/Gynecology

• Shannon Bradley, MD
  Area of Expertise: Obstetrics/Gynecology

• Jan Bury, MD
  Area of Expertise: Obstetrics/Gynecology

• Thomas Hutchens, MD
  Area of Expertise: Obstetrics/Gynecology

• Joan Connell, MD
  Area of Expertise: Pediatrics

• Carla Zacher, MD
  Area of Expertise: Pediatrics

• Kathryn Obregon, MD
  Area of Expertise: Pediatrics

• Siriwan Kriengkrairut, MD
  Area of Expertise: Pediatric Neurology

• James Hughes, MD
  Area of Expertise: Pulmonology

• Somsak Kriengkrairut, MD
  Area of Expertise: Pulmonology

• Monica Paulo, MD
  Area of Expertise: Pulmonology

• Nowarat Songsiridej, MD
  Area of Expertise: Rheumatology

• Lewis N. Cunningham, DO
  Area of Expertise: Urology

• Stan T. Diede, MD
  Area of Expertise: Cardiovascular Diseases, Internal Medicine

• John J. Hagan, MD
  Area of Expertise: Internal Medicine

• Keith R. Happel, MD
  Area of Expertise: Internal Medicine

• Paul E. Jondahl, MD
  Area of Expertise; Family Practice

• Mustafa Kathawala, MD
  Area of Expertise: Gastroenterology, Internal Medicine

• Kathleen Nordstrom, MD
  Area of Expertise: Radiation Oncology

• Julie M. Schwartz, MD
  Area of Expertise: Internal Medicine

• Marny Hauge, PsyD
  Area of Expertise: Child & Adolescent Psychology

• Craig Degree, PhD
  Area of Expertise: Psychology

• Terri Hanson, PhD
  Area of Expertise: Psychology

• Niran Kotrapu, MD, FAAP, FRCP
  Area of Expertise: Pediatric & Neonatal Cardiology

• Amer Yar Khan, MD
  Area of Expertise: Internal Medicine

• Brian J. Hebert, MD
  Area of Expertise: Internal Medicine

• Robert G. Oatfield, MD
  Area of Expertise: Cardiology

• Cindy Kaye Sharp, MD
  Area of Expertise: Nephrology

• Richard Arazi, MD
  Area of Expertise: Neurology

• Jose Wiley, MD
  Area of Expertise: Cardiology
• Vijayarama Rao Phooshkooru, MD
  Area of Expertise: Oncology
• Nicholas Henry Neumann, MD, MMM, FACP,FCP, CHE
  Area of Expertise: Pulmonology
• Prashant Kaushik, MD
  Area of Expertise: Rheumatology
• Jeffrey Eugene Hostetter, MD
  Area of Expertise: Internal Medicine
• Michael Ray Brown, MD, PhD, FACS
  Area of Expertise: Cardiothoracic Surgery
• Kevin Robert Dahmen, MD
  Area of Expertise: Pediatric Psychiatry
• Steven Douglas Spotts, MD
  Area of Expertise: Otolarynology
• Troy Darin Pierce, MD, MS
  Area of Expertise: Orthopedics
• Leslie Mark Rainwater, MD, FACS
  Area of Expertise: Urology
• Heidi Jane Goldstein, MD
  Area of Expertise: Pediatric Physiatry
• Eric Belanger, MD
  Area of Expertise: Neurosurgery
• Donald Howard Grenz, MD
  Area of Expertise: Internal Medicine
• FEK Addo, MD
  Area of Expertise: Oncology
• Supha Kijpttayarit Arthurs, MD
  Area of Expertise: Infectious Disease
• David Harold Larsen, DO
  Area of Expertise: Orthopedics
• Timothy John Bopp, MD
  Area of Expertise: Orthopedics
• Michelle Mjelstad Maier, APRN, BC
• Tanya Patzer Guthmiller, FNP
• Heather Jacobsen Bauer, RN, FNP
• Cammy Schafer Olson, MSN, FNP-C
• Carol Koenig Miller, RN, FNP

Dan McPherson, PharmD, BCNSP
Area of Expertise: Cardiology/Critical Care/Nutrition
20 years experience in clinical research

Deb McPherson, PharmD, BCNSP
Area of Expertise: Pediatrics/Neonatal Intensive Care/Nutrition
20 years experience in clinical research

Dawn Gronneberg, PharmD
Area of Expertise: Anticoagulation Services
8 years experience in clinical research

Julie Wetzstein, CCRC
10 years experience in clinical research

Kara Finneman, CCRC
8 years experience in clinical research

Sheri Hardy, LPN, CCRC
4 years experience in clinical research

Jackie Mattison, Research Secretary/Specialist

Joan Johnson, RPh
Area of Expertise: Oncology/Hospice
25 years experience in clinical research

Kenton Omvig, PharmD
Area of Expertise: Geriatrics/General Practice
14 years experience in clinical research

Carrie Sorenson, PharmD
Area of Expertise: Surgery/Infectious Disease
8 years experience in clinical research

Mindy Sturn, Business Development & Regulatory Specialist
1 years experience in clinical research

Characteristics of our patients include prominent northern European and Native American populations with a low drop-out rate and low incidence of communicable diseases. We also have the largest per capita diabetes population in the nation. Our service area encompasses central, eastern, and western North Dakota, northern South Dakota, eastern Montana, and western Minnesota. This area is made up of a population of approximately 300,000 individuals.

Clinical Research Services has the option of using our own local Institutional Review Board or central IRBs for clinical trials.

Our department personnel have experience in using Remote Data Entry.

CenterWatch is listing the following trials that are actively recruiting patients at this center.

• A research study for Acute Otitis Media
• A research study for patients with metastatic prostate cancer
• A research study for prostate cancer patients
• A research study to determine the safety and effectiveness of a carotid stent system
• A study for rheumatoid arthritis
• A women's health research study

For more information, please contact:

Elaine Kucera, MM, MT(ASCP) SBB
Director, Clinical Research Services
St. Alexius Medical Center
Clinical Research Services
810 E Rosser Ave.
Suite 202
Bismarck, ND 58501 USA
Phone: 701-530-6954
Fax: 701-530-6970
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on August 21, 2008