Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:June 8, 2015
End Date:April 19, 2024
Contact:Reference Study ID Number: GA29145 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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Trial Summary
Trial Overview
Inclusion Criteria

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

This two-part, open-label extension and safety monitoring study will examine the safety and
efficacy of continued etrolizumab treatment in patients with moderate to severely active
Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.


Inclusion Criteria:

Part 1 Open-label Extension:

- Patients previously enrolled in etrolizumab Phase III study GA29144 who meet the
eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

- Patients who participated in etrolizumab Phase III study GA29144 and are not eligible
or choose not to enter Part 1

- Patients who transfer from Part 1

- Completion of the 12-week safety follow-up period prior to entering

Exclusion Criteria:

Part 1 Open-label Extension:

- Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

- No exclusion criteria
We found this trial at
131
sites
Texas Digestive Disease Consultants - Dallas
3409 Worth Street
Dallas, Texas 75231
347
mi
from
Dallas, TX
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
1038
mi
from
Chapel Hill, NC
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Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
569
mi
from
Houston, TX
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Indiana University
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
642
mi
from
Indianapolis, IN
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
571
mi
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Jackson, MS
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Borland-Groover Clinic
4800 Belfort Rd # 2
Jacksonville, Florida 32256
1062
mi
from
Jacksonville, FL
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Kinston Medical Specialists
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
1133
mi
from
Kinston, NC
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University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
725
mi
from
Lexington, KY
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Gastroenterology Associates of Central Georgia
610 3rd St # 206
Macon, Georgia 31201
868
mi
from
Macon, GA
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Center for Advanced Gastroenterology
260 Lookout Pl # 201
Maitland, Florida 32751
1138
mi
from
Maitland, FL
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
618
mi
from
Nashville, TN
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Internal Medicine Specialists
Orlando, Florida 32806
1143
mi
from
Orlando, FL
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International Clinical Research
819 E 1st St # 6
Sanford, Florida 32771
1135
mi
from
Sanford, FL
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
1113
mi
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Tampa, FL
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Shafran Gastroenterology Center
701 West Morse Boulevard
Winter Park, Florida 32789
1140
mi
from
Winter Park, FL
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University of Michigan Health System
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
808
mi
from
Ann Arbor, MI
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Valley Gastroenterology Consultants
Arcadia, California 91006
1155
mi
from
Arcadia, CA
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Texas Physicians Medical Research Group
Arlington, Texas 76015
348
mi
from
Arlington, TX
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Asheville Gastroenterology Associates, P.A.; Gastroenterology
191 Biltmore Avenue
Asheville, North Carolina 28801
858
mi
from
Asheville, NC
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Agile Clinical Research Trials,LLC
750 Hammond Drive Northeast
Atlanta, Georgia 30342
798
mi
from
Atlanta, GA
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
803
mi
from
Atlanta, GA
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Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
798
mi
from
Atlanta, GA
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Innovative Medical Research of South Florida Inc.
Aventura, Florida 33180
1314
mi
from
Aventura, FL
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Gastroenterology Associates
Baton Rouge, Louisiana 70809
637
mi
from
Baton Rouge, LA
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Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
192
mi
from
Belton, MO
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Massachusetts General Hospital - Crohn's & Colitis Center
Boston, Massachusetts 02114
1444
mi
from
Boston, MA
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
1445
mi
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Brockton, MA
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Investigator's Research Group
Brownsburg, Indiana
631
mi
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Brownsburg, IN
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Hospital Italiano
Caba,
?
mi
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Caba,
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Ventura County Gastroenterology
Camarillo, California 93012
1208
mi
from
Camarillo, CA
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
1063
mi
from
Charleston, SC
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Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina 28207
959
mi
from
Charlotte, NC
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University of Virginia; Gastroenterology and Hepatology
1215 Lee Street
Charlottesville, Virginia 22908
1051
mi
from
Charlottesville, VA
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Clin. Rsrch Inst. of Michigan
30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
860
mi
from
Chesterfield, MI
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Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
1124
mi
from
Chevy Chase, MD
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
609
mi
from
Chicago, IL
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Northwestern Uni-Feinberg School of Medicine
Chicago, Illinois 60611
?
mi
from
Chicago, IL
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Consultants for Clinical Research Inc.
Cincinnati, Ohio 45219
725
mi
from
Cincinnati, OH
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UC Health Clinical Trials Office
Cincinnati, Ohio 45206
728
mi
from
Cincinnati, OH
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West Central Gastroenterology d/b/a Gastro Florida
3001 Executive Drive
Clearwater, Florida 33762
1109
mi
from
Clearwater, FL
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
898
mi
from
Cleveland, OH
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Ericksen Research And Development
Clinton, Utah 84015
792
mi
from
Clinton, UT
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Peak Gastroenterology Associates; Gastroenterology
Colorado Springs, Colorado 80907
387
mi
from
Colorado Springs, CO
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Columbus Regional Research Institute
Columbus, Georgia 31904
807
mi
from
Columbus, GA
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GastroCare; Digestive Care Research
3001 Coral Hills Drive
Coral Springs, Florida 33065
1295
mi
from
Coral Springs, FL
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
349
mi
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Dallas, TX
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
805
mi
from
Decatur, GA
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Rocky Mountain Gastroenterology Associates
Denver, Colorado 80222
409
mi
from
Denver, CO
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Iowa Digestive Disease Center
1378 Northwest 124th Street
Des Moines, Iowa 50312
341
mi
from
Des Moines, IA
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Jesscan Medical Research
10200 Northwest 25th Street
Doral, Florida 33172
1312
mi
from
Doral, FL
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University of Louisville
301 East Muhammad Ali Boulevard
Elizabethtown, Kentucky 42791
657
mi
from
Elizabethtown, KY
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Cumberland Research Associates
Fayetteville, North Carolina 28304
1063
mi
from
Fayetteville, NC
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University of Florida College of Medicine
3450 Hull Road
Gainesville, Florida 32610
1047
mi
from
Gainesville, FL
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Valley View Internal Medicine
Garden Grove, California 92843
1158
mi
from
Garden Grove, CA
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Gastro One
Germantown, Tennessee 38138
481
mi
from
Germantown, TN
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Valley Gastroenterology Cnslts
Glendora, California 91741
1146
mi
from
Glendora, CA
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Gastroenterology Associates of Western Michigan, P.L.C.
2093 Health Drive Southwest
Grand Rapids, Michigan 49506
727
mi
from
Grand Rapids, MI
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Long Island Clin Rsch Asc, LLP
Great Neck, New York 11021
1301
mi
from
Great Neck, NY
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Innovative Clinical Research
7021 Augusta Road
Greenville, South Carolina 29604
883
mi
from
Greenville, SC
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
1345
mi
from
Hamden, CT
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Center for Gastrointestinal Disorders
Hollywood, Florida 33021
1309
mi
from
Hollywood, FL
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The Methodist Hospital Research Institute
Houston, Texas 77030
572
mi
from
Houston, TX
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Grand Teton Research Group
Idaho Falls, Idaho 83404
839
mi
from
Idaho Falls, ID
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Atlantic Medical Group
Kinston, North Carolina 28501
1134
mi
from
Kinston, NC
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University of California, San Diego Medical Center
La Jolla, California 92093
1118
mi
from
La Jolla, CA
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Therapeutic Research Institute of Orange County
Laguna Hills, California 92653
1149
mi
from
Laguna Hills, CA
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Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
7000 West Colfax Avenue
Lakewood, Colorado 80215
414
mi
from
Lakewood, CO
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Florida Center for Gastroenterology
Largo, Florida 33777
1103
mi
from
Largo, FL
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VA Long Beach Healthcare System
Long Beach, California 90822
1167
mi
from
Long Beach, CA
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University of Wisconsin
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
574
mi
from
Madison, WI
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
788
mi
from
Marietta, GA
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Community Clinical Research Network
Marlborough, Massachusetts 01752
1419
mi
from
Marlborough, MA
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Advanced Medical Research
4730 West Bancroft Street
Maumee, Ohio 43537
798
mi
from
Maumee, OH
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Great Lakes Gastroenterology Research
Mentor, Ohio 44060
915
mi
from
Mentor, OH
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City Medical Group
1611 Northwest 12th Avenue
Miami, Florida 33130
1319
mi
from
Miami, FL
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Advanced Clinical Research of Miami
Miami, Florida 33155
1317
mi
from
Miami, FL
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Regenerate Clinical Trials
Miami, Florida 33155
1321
mi
from
Miami, FL
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IMIC, Inc
Miami Beach, Florida 33140
1323
mi
from
Miami Beach, FL
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FQL Research, LLC
Miramar, Florida 33025
1307
mi
from
Miramar, FL
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Gastroenterology Group of Naples
Naples, Florida 34102
1231
mi
from
Naples, FL
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Aquiant Research
2630 Grant Line Road
New Albany, Indiana 47150
653
mi
from
New Albany, IN
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North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation
1999 Marcus Avenue
New Hyde Park, New York 11042
1303
mi
from
New Hyde Park, NY
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Advanced Research Institute, Inc
New Port Richey, Florida
1096
mi
from
New Port Richey, FL
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Concorde Medical Group
New York, New York 10016
1288
mi
from
New York, NY
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Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York 10021
1289
mi
from
New York, NY
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Mount Sinai - PRIME
New York, New York 10029
1290
mi
from
New York, NY
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Lenox Hill Hospital
New York, New York 10021
1289
mi
from
New York, NY
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Digestive and Liver Disease Specialists
Norfolk, Virginia 23502
1186
mi
from
Norfolk, VA
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Central Sooner Research
Norman, Oklahoma 73069
175
mi
from
Norman, OK
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Clinical Trials of South Carolina
North Charleston, South Carolina 29406
1054
mi
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North Charleston, SC
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Med-Care Research
North Miami Beach, Florida 33162
1314
mi
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North Miami Beach, FL
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California Medical Research Associates Inc.
Northridge, California 91324
1181
mi
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Northridge, CA
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Southwest Gastroenterology
Oak Lawn, Illinois 60453
600
mi
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Oak Lawn, IL
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Advanced Research Institute
Ogden, Utah 84405
789
mi
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Ogden, UT
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University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
154
mi
from
Oklahoma City, OK
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Quality Clinical Research, Inc.
10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
260
mi
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Omaha, NE
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University of California, Irvine Medical Center
101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
1153
mi
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Orange, CA
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Medical Research Group of Central Florida
Orange City, Florida 32763
1128
mi
from
Orange City, FL
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Premier Medical Group of the Hudson Valley
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
1294
mi
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Poughkeepsie, NY
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McGuire Research Institute; Gastroenterology
Richmond, Virginia 23249
1111
mi
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Richmond, VA
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