Document text
C4591001 Page 1of 17
CONFIDENTIAL 15-Nov-2021 11:54:10 GMT
16.1.4.1 LIST OF INVESTIGATORS AND NUMBER OF SITES AND PARTICIPANTS BY COUNTRY
Total Number of Sites (Per Study ):29
Total Number of Subjects Screened (Per Study ): 2268
Total Number of Subjects Randomized/Entered (Per Study ):2268
UNITED STATES
Number of Sites (Per Country ): 29
Number of Subjects Screened (Per Country ): 6713
Number of Subjects Randomized/Entered (Per Country ): 6500
Coordinating Investigator:
Stephen Thomas
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1005 Matthew Davis Chelsea Bork
Michelle Burgett
Therese Dayton
Kathleen Ebeling
Victoria Fink
Jennifer Foley
Deborah Hodges
Sarah Ingalsbe -Geno
Patricia Larrabee
Joseph Mann
Julie Mooney
Katherine
Pagenkemper
Tammi Shlotzhauer
Susan WillerRochester Clinical Research, Inc.
500 Helendale Rd, L20
Rochester, NY 14609
UNITED STATES34 34
Rochester Clinical Research, Inc.
500 Helendale Rd, Ste 265
Rochester, NEW YORK 14609
UNITED STATES
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Jaclyn Zona
Zerina Zornic
Jenna Baer(Previous
SubI)
Julie
Callahan(P revious
SubI)
Cristina
Cramer -Mills(Previou
s SubI)
Kara
Cristales(Previous
SubI)
Geesue Hah(Previous
SubI)
Previous SubI)
Diana
Kailburn(Previous
SubI)
Mackay
Kanaley(Previous
SubI)
Abigail
Miller(Previous SubI)
Jennifer
Rowlinson(Previous
SubI)
Sally
Thomas(Previous
SubI)
Julie
Wentw orth(Previous
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
1006 James Peterson Natalie Bee
Alexander Clark
Shana Eborn
Susan Edwards
Dan Henry
Heather Jackson
Gerald Kelty
Jacqueline Rohrer
Issac
Pena- Renteria(Previo
us SubI)
Jack Taylor(Previous
SubI)J. Lew is Research, Inc. / Foothill Family Clinic
2295 Foothill Dr
Salt Lake City, UT 84109
UNITED STATES89 89
1007 Robert Frenck Rebecca Brady
Kristen Buschle
Michelle Dickey
Grant Paulsen
Felicia Scaggs -Huang
Paul Spearman
Eleanor Widdice
David
Bernstein(Previous
SubI)Cincinnati Children's Hospital Medical Center
Cincinnati Center for Clinical Research (CCCR)
619 Oak St
Cincinnati, OH 45206
UNITED STATES173 173
Cincinnati Children's Hospital Medical Center
Gam ble Program for Clinical Studies
3333 Burnet Ave, MLC 6014
Cincinnati, OH 45229 -3039
UNITED STATES
1008 Timothy
Jennings Tonya Clausen
Siddharth Kaul
Anthony Margherita
Brittany Nguyen
Ann PatekClinical Research Professionals
17998 Chesterfield Airport Rd, Ste 100
Chesterfield, MO 63005
UNITED STATES179 179
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Fredric Prater
Dawn Ringling
Richard Summa
Terry Weis
Alaina Yarber
Stacey
Miner(Previous SubI)
1009 Shane
ChristensenHolly Anderson
Emily Bloomquist
Ross Brunetti
Thomas Conner
Gina Cox
Diana Grazulis
Wesley Lewis
James Longe
Christopher Matich
Bryan Nelson
John Witbeck
Stephen Wood
Emily
Raming(Previous
SubI)
Sarah Scott(Previous
SubI)J. Lew is Research, Inc. / Foothill Family Clinic South
6360 S 3000 E, Ste 100
Salt Lake City, UT 84121
UNITED STATES158 158
1013 Michael Dever Chanel Adams
Patricia Brow n
Joan Cutillo
Letitia Griffin
Linda Harper
Rebecca Klipper
Robert Molpus
Priya MoorhouseClinical Neuroscience Solutions, Inc. dba CNS Healthcare
618 E. S St, Ste 100
Orlando, FL 32801
UNITED STATES53 53
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Penny ONeal
Felipe Suplicy
Geraldine
Marino(Previous
SubI)
Deborah
Renner(Previous
SubI)
Trey (William)
Schesser(Previous
SubI)
1016 Daniel Finn Ashley Bennett
Melanie Bishop
Lindsay Blackmon
Stanley Block
Christal Denton
Lisa Dones
Rebecca Findlay
Kayla Hamilton
James Hedrick
Kali Lewis
Brittany Lisby
Wendy Mattingly
Michelle Newton
Martha Osbourn
Robert Smith
Monica Strenecky
Ronald Tyler
Shannon Woods
Whitney
Downs(Previous Kentucky Pediatric/ Adult Research
201 S 5th St
Bardstown, KENTUCKY 40004
UNITED STATES65 65
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
Erica Koch(Previous
SubI)
Abby
O'Bryan -Wimsett(Pre
vious SubI)
Lea Rust(Previous
SubI)
Andrea
Yates(Previous SubI)
Tabitha
Yates(Previous SubI)
1039 Gretchen Crook Jennifer Beanblossom
Kristen Hansen
Peterman
Sarah Higgs
Camille Horony
Ana Paez
Bandana Risal
Linda
Nguyen(Previous
SubI)
Amy Siegel(Previous
SubI)ARC Clinical Research at Wilson Parke
11714 Wilson Parke Ave., Ste 150
Austin, TX 78726
UNITED STATES88 88
1044 Aaron Hartman Raymond Decker
Rachel
Martin(Previous
SubI)Virginia Research Center LLC
13911 St. Francis Blvd., Ste 101
Midlothian, VA 23114
UNITED STATES133 133
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
1057 Fadi Chalhoub Susan Angel
Sujeeta Dhakhw a
Brett Gellers
Nandita Jones
John Mark Joyce
Niketa KambleClinical Neuroscience Solutions, Inc.
5200 Belfort Rd, Ste 420
Jacksonville, FL 32256
UNITED STATES78 78
1066 David Butuk Janelle Barney
Janaie Bounsana
Erin Brennan
Melissa Conrad
Scott Frisby
Paige McKenzie
Kaylee Ruckrigl
Meredith
Mangum(Previous
SubI)Solaris Clinical Research
1525 E Leigh Field Dr, # 100
Meridian, ID 83646
UNITED STATES36 36
1077 Suchet Patel Caitlyn Burford
Kimberly Desantis
Michael Federico
Dem etrios Gasparis
Lazarus Gehring
James Holler
Eric Lorraine
Katherine Macarak
Rekha Patel
John Perry
Duncan Sze -TuMeridian Clinical Research
415 Hooper Rd
Endw ell, NEW YORK 13760
UNITED STATES26 26
Meridian Clinical Research LLC
409 Hooper Rd
Endw ell, NEW YORK 13760
UNITED STATES
1084 Douglas
DenhamAyoade Avworo
Maristelle Co
Parke Hedges
Matthew KorteClinical Trials of Texas, Inc.
(Storage Only)
5430 Fredericksburg Rd., Ste 601
San Antonio, TEXAS 7822954 54
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Mary Perez -Jenkins
Cynthia Ramos
Thomas Weiss
Darlington
Akahara(Previous
SubI)
Muhammad
Ata(Previous SubI)
Stephen
Brick(Previous SubI)
Cathleen
Chen(Previous SubI)
Graham
Ellis(Previous SubI)
Kimberly
Evans(Previous SubI)
Zachariah
Francois(Previous
SubI)
Anshumaan
Maharaj(Previous
SubI)
Clayton
Stone(Previous SubI)UNITED STATES
Clinical Trials of Texas, Inc.
5430 Fredericksburg Rd, Ste 200
San Antonio, TEXAS 78229
UNITED STATES
1091 Samir Arora
Brennan Brothers
Grazia Cannon
Jordan Carpenter
Jess DeMaria
Roger Faubel
Allison ForsytheAventiv Research Inc (Facility and Drug Shipment Address)
99 N. Brice Rd, Ste 260
Columbus, OHIO 43213
UNITED STATES70 70
Aventiv Research Inc.
99 N. Brice Rd, Ste 210
Columbus, OHIO 43213
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Sridhar Guduri
Layne Mikanik
Lindsay Newton
Roy St. John
Sarah Wilcox
Rafe Bari(Previous
SubI)
Brittany
Biro(Previous SubI)
Previous SubI )
Danijela
Cvijetinovic(Previous
SubI)
Sophia
Gaines(Previous
SubI)
Jessica
Harpel(Previous
SubI)
Chelsea
Hughes(Previous
SubI)
Grace
Purkey(Previous
SubI)
Jessica
Spear(Previous SubI)UNITED STATES
1123 Brandon Essink
Laura Falcone
Roni Gray
Frederick RaiserMeridian Clinical Research, LLC
3319 N 107th St.
Omaha, NEBRASKA 6813489 89
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Akossiwa Yovogan
Jacob
Bumsted(Previous
SubI)
Cassie
Heisey(Previous
SubI)
Linda
Layton(Previous
SubI)
Jay Meyer(Previous
SubI)
Kimberly
Mueller(Previous
SubI)
Tiffany
Nem ecek(Previous
SubI)UNITED STATES
1124 David Fried Jacqueline DiFazio
Patricia Feole
Helena Godley
Kristina Haughey
Lynne Haughey
Courtney Langlois
Amanda ONeill
Johnna Pezzullo
Lisa Rameaka
Ariana Stanton
Amanda
Cole(Previous SubI)
Molly
Savitzky(Previous Velocity Clinical Research, Providence
400 Bald Hill Rd
Warw ick, RI 02886
UNITED STATES39 39
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
SubI)
1125 Charles Harper Sally Eppenbach
Alisha Kiepke
Cathy Laflan
Wendell Lewis
Brett Loseke
Chelsie Nutsch
Keith Vrbicky
Kari Uhlir(Previous
SubI)Meridian Clinical Research, LLC
1410 N 13th St, Ste 5
Norfolk, NE 68701
UNITED STATES12 12
1126 Nicola Klein Rebecca Alexander
Janelle Baires
Latisha Burun
Christine Cash
David Cooper
JOLYNNE
ENCARNACION
Douglas Ernst
Lauren Fontenot
La Vonne Freed
Sarah Kang
Rom a Kullar
Ludy Lemus
Eva Lowe
Lorrie Lowe
Nicole Makram
Shannon Mullen
Courtney Oxandale
Kenneth Purdy
Sally Upadhyaya
Dana Weisshaar
Amy WiesnerKaiser Permanente Sacramento
1650 Response Rd
Sacramento, CA 95815
UNITED STATES75 75
Kaiser Permanente Santa Clara
710 Law rence Expy
Santa Clara, CALIFORNIA 95051
UNITED STATES
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Jessica
Barraza(Previous
SubI)
Gail Cook(Previous
SubI)
Jeremy
Giese(Previous SubI)
Julia
Glanternik(Previous
SubI)
Lisa
Kennedy(Previous
SubI)
Rebekah
Kotyk(Previous SubI)
1131 William Randall
Ann Moell
Crystal Osman
Caitlyn Smith
Gilbert Templeton
Heather
Goins(Previous SubI)
Zachariah
Kom on(Previous
SubI)
Kimberly
Lyons(Previous SubI)
(Previous SubI)PriMED Clinical Research
948 Patterson Rd
Dayton, OHIO 45419
UNITED STATES25 25
1139 Emmanuel
WalterMichael Smith
Christopher Accessioning Unit and Repository
2 Genome Court
Durham, NORTH CAROLINA 27710107 107
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Clark(Previous SubI)
Jennifer
Dougherty(Previous
SubI)
Geeta
Swamy(Previous
SubI)UNITED STATES
Clinical Research Pickett Road
3024 Pickett Rd, Durham County
Durham, NORTH CAROLINA 27705
UNITED STATES
Duke University Medicine Circle -Duke Early Phase Clinical Research
Unit
40 Duke Medicine Circle
Durham, NC 27710
UNITED STATES
Duke Vaccine and Trials Unit
2608 Erwin Rd, Ste 210
Durham, NORTH CAROLINA 27705
UNITED STATES
1140 Stephen Thom asKathryn Anderson
Elizabeth
Asiago -Reddy
DONALD BLAIR
RACHAEL
CAVELLI
Joseph Domachowske
Sriharsha Gowtham
Elizabeth Harausz
Kristopher Paolino
Timothy
Endy(Previous SubI)SUNY Upstate Medical University
Institute for Human Performance
505 Irving Ave, Clinical Research Unit
Syracuse, NEW YORK 13210
UNITED STATES75 75
SUNY Upstate Medical University Global Health Research Unit
4900 Broad Rd, Onondaga County, POB N Ste 4U
Syracuse, NEW YORK 13215
UNITED STATES
1142 Richard Rupp Megan Berman
Cori Burkett
Laura Porterfield
Elizabeth University of Texas Medical Branch
SIVS Clinical Trials Program, Primary Care Pavilion, 400 Harborside
Dr., Ste 126
Galveston, TEXAS 7755563 63
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Ginn(Previous SubI) UNITED STATES
1147 Julia
Garcia- DiazJulie Castex
Hailey
Anderson(Previous
SubI)
Melinda
Benvenuti(Previous
SubI)
Freda
Dunhurst(Previous
SubI)
Lisa
Fredenburg(Previous
SubI)
Jenna
Griffin(Previous
SubI)
Samuel
King(Previous SubI)
James
McMullen(Previous
SubI)Ochsner Clinic Foundation
1514 Jefferson Hwy
New Orleans, LA 70121
UNITED STATES78 78
1150 Shelly Senders Sarah Ball
Elizabeth Bucchieri
Laura Caserta
Christopher
Fackelmann
Caitlin Fillioe
Kelly Kelmes
Katie Passarell
Jill Sangree
Allison Senders Pediatrics
2054 S Green Rd
South Euclid, OH 44121
UNITED STATES144 144
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Effron(Previous SubI)
Jennifer
McKinnon(Previous
SubI)
Keili
Mistovich(Previous
SubI)
Eliza
Pereira(Previous
SubI)
1152 Donald Brandon William Davis
Daniel LawlerCalifornia Research Foundation
4180 Ruffin Rd, Ste 255
San Diego, CALIFORNIA 92123 -1881
UNITED STATES138 138
1156 Hector
RodriguezArmando Acevedo
Armando Garcia
Yeniska Hall Nieves
Lizz Hernandez Diaz
Iris Izquierdo
Alina Monteagudo
Canto
Israel Zagales
Elaine
Martinez(Previous
SubI)Acevedo Clinical Research Associates
2400 Nw 54th St
Miami, FL 33142
UNITED STATES88 88
1223 Onyema
OgbuaguLaurie Andrews
Jessica Tuan
Thilinie
Bandaranayake(PreviYale Center for Clinical Investigations (CSRU)
2 Church St S, Ste 114
New Haven, CT 06519
UNITED STATES19 19
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CONFIDENTIAL 15-Nov-2021 11:54:10 GMT
Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
ous SubI)
Melissa
Campbell(Previous
SubI)
Frances
Santiago(Previous
SubI)Yale University
School of Medicine
135 College St, Ste 392
New Haven, CT 06510
UNITED STATES
Yale -New Haven Hospital
55 Park St, LL -15
New Haven, CT 06511
UNITED STATES
1235 John Vanchiere Pat Bass
Paul Cooper
Keith Scott(Previous
SubI)LSU Health Sciences Center at Shreveport Clinical Trials Office
1801 Fairfield Ave, Ste 203
Shreveport, LA 71101
UNITED STATES20 20
LSUHSC -Shreveport
1501 Kings Hwy
Shreveport, LA 71103
UNITED STATES
1270 Nicola Klein Rebecca Alexander
Janelle Baires
Latisha Burun
Christine Cash
David Cooper
JOLYNNE
ENCARNACION
Douglas Ernst
Lauren Fontenot
La Vonne Freed
Sarah Kang
Rom a KullarKaiser Permanente Sacramento
1650 Response Rd
Sacramento, CA 95815
UNITED STATES59 59
Kaiser Permanente Santa Clara
710 Law rence Expy
Santa Clara, CALIFORNIA 95051
UNITED STATES
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Study
Site
NumberPrincipal
Investigator Sub-Investigator Study Conducted at Address(es)Subjects
Screened
per SiteSubjects
Randomized/
Entered per Site
Ludy Lemus
Eva Lowe
Lorrie Lowe
Nicole Makram
Shannon Mullen
Courtney Oxandale
Kenneth Purdy
Sally Upadhyaya
Dana Weisshaar
Amy Wiesner
Jessica
Barraza(Previous
SubI)
Gail Cook(Previous
SubI)
Jeremy
Giese(Previous SubI)
Lisa
Kennedy(Previous
SubI)
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Protocol C4591001
16.1.4. 2List of CROs and Vendors
CONFIDENTIAL
Page 1List of Contract Research Organizations and Vendors
CRO or Vendor Name and Address( es) Service Conducted
Almac Clinical Services LLC
25 Fretz Road
Souderton PA 18964
United StatesClinical Research Pharmacist Pfizer
Investiga tional Product Coordinat or
Support
C3i Solutions
410 Horsham Road
Horsham, PA 19044
United StatesMedical Escalation and IRT Unblinding
Suppo rt
CRF Health Management L imited, an
affiliate of Bracket Global LLC
Ground Floor
Waterfront Building
Manbre Road
Hammersmith
Londo n
W6 9RH
United KingdomSubject D ata Assessment Tool (eDiary )
and Data Collection
DrugDev Inc.(anIQVIA com pany)
228 N. Market Street
Frederick , MD 21701
Unite d StateseConsent Services
Eliassen Group
55 Walkers Brook Drive, 6thFloor
Reading, M A 01867
United State sStatistical Programming
Execupharm
610 Freedom Business Center Drive, Suite
200
King of Prussia,
PA 19406
United StatesStudy Management
090177e1989ac413\Approved\Approved On: 16-Nov-2021 02:47 (GMT)
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Protocol C4591001
16.1.4. 2List of CROs and Vendors
CONFIDENTIAL
Page 2CRO or Vendor Name and Address( es) Service Conducted
ICON Clinical R esearch Lim ited
South County Business Park
Leopardstown, Dublin 18
IrelandStudy Manage ment
Investiga tor Si te Monitoring
MMS Holdings Inc.
6880 Commer ce Boulevard
Canton, MI 48187
United StatesMedical Writin g (Clinical Study Report
Narratives)
PRA Health Sciences
4130 Park Lake A venue
Suite 400,
Raleigh, NC 27612
United States Study Management
Premier R esearch Group Limited
234 C opeland Street Suite 400
Quincy, MA 02169
United State sClinical Trial Coding, Dictionary
Mapping and Mainten ance
Syneos Health
1030 Sy nc Street
Morr isville,
North Carolina, 27560
USA Statistical A nalysis
Tata America International
7th Floor, Trent House
G-Block, Bandra Kurla Complex
Mumbai 400051
IndiaStatistical Program ming
VerilyLife Scie nces LLC
269 East Grand Ave nue
South San Francisco, C A 94080
United Sta tesRecruitment Services
WCG-T HREEWI REInc.
7500 Fly ing Cl oud Drive
Suite 300
Eden Prairie, MN 55344
United State sClinical R esearch Coordina tor Support
for Invest igator Sites
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