UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF FLORIDA

CASE NO.

18 U.S.C. j 371

18 U.S.C. j 981(a)(1)(C)

UM TED STATES OF AM ERICA

V.

ANG ELA M ARIA GIRON,

D efendant.

/

INFORM ATION

The United States Attorney charges that:

GENERAL ALLEGATION S

At all tim es relevant to this Information:

1. Clinical investigations, also known as clinical trials, were research studies

conducted on voltmtary hlzman subjects designed to answer specitk questions about the safety or

effectiveness of new drugs. Drug developers, or tGsponsors,'' initiated and took responsibility for

clinical trials.

The United States Food and Drug Administration (1TDA'') was responsible for

ensuring that drtzgs intended for htlm an use were safe and effective. The FDA relied on the

tnzthfnlness and acctlracy of the results of clinical trials to m ake regulatory decisions about the

approval of new drugs.

Before beginning a clinical trial, sponsors were required to provide the FDA with

extensive inform ation regarding the proposed trial, including a detailed investigational plan

known as a çEstudy protocol.'' The study protocol described, among other things, the eligibility and

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Sep 30, 2022

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MM
exclusion criteria for smdy subject selection, schedules of tests and procedures, drug and dosage

regimens, a description of observations and m easlzrem ents to be m ade to fulfill the clinical trial's

objectives, the length of the study, and the health outcomes to be measured by the study. Clinical

tzials were required to be conducted according to the study protocol, as well as any applicable laws

and FDA regulations.

4. Sponsors generally retained contract research orgnnizations (C(CROs'') to oversee

and m anage vadous aspects of clinical trials. Sponsors and CROs typically contracted with

m ultiple trial sites to perform clinical trials. Under such an arrangem ent, each individual clinical

trial site was responsible for identifying and screening sttldy subjects, enslzdng the subjects met

eligibility criteria, ezlrolling them into the clinical trial, perfonning the clinical trial, gathering data,

and reporting the data to the sponsor and/or CRO, in accordance with the study protocol.

5. Sponsors generally contracted with third-party companies to m anage the sttldy data

system , process the sttzdy data submitted by the clinical trial sites, and to track, send to and receive

from the clinical trial sites the study m edications. Sponsors also generally contraded with thirdparty laboratories to receive, test, and analyze samples obtained from subjects that were sent by

the clinical trial sites to the laboratodes.

6. An lnstitutional Review Bord was an organization form ally designated to monitor

and review a clinical trial throughout its com se. An Institutional Review Board had the authority

to review, require m odilcations to, or disapprove research.

7. Each clinical trial site had a clinical investigator, also known as a principal

investigator. The clinical investigator was the individual responsible for conducting the clinical

investigation at that clinical trial site and enstlring that the clii cal trial was conducted according

to the study protocol and in compliance with all applicable FDA regulations. Responsibilities of

the clinical investigator included personally conducting or supervising the clinical trial, including

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all requirements regarding the qualiscation of the subjects; obtaining informed consent from

subjects; dispensing study medication; collecting and reporting data; reporting adverse events; and

enslzring that all employees worldng on the study met those snm e obligations.

8. The clini' ca1 investigator also was required, by regulation, to prepare and m aintain

records relating to clinical trials. These records, known as çtcase histories,'' included adequate

records of the disposition of the study drug, including dates and quantities of drugs dispensed to

subjects; irlfonned consent forms and medical records for each subject participating in the clinical

trial; and records of a11 observations and other data pertinent to the investigation for each subject

adm inistered an experim ental drug. The clirlical investigator had the authority to delegate certain

responsibilities to clinical trial site staff working on the clinical trial.

9. The FDA had the authority to inspect a clinical investigator to ensure that the

clirlical investigator was com plying with a1l applicable laws and regulations in conducting clinical

trials. The FDA 'S inspection authority included the authority to review case M stories and other

records maintained by the clinical investigator.

10. A clinical investigator provided to the sponsor and/or the CRO information about

each subject screened for and emolled in the smdy, induding his or her medical histoty, laboratov

results, and reaction to the drug tmder study. The sponsor then provided the information to the

FDA for its use in evaluating whether the drug was safe and effective and should be approved for

its intended use.

The Defendant and the Co-conspirators

1 1. AM B Research Center, lnc. (ûGAMB Research Center'') was a medical clinic located

in M inm i, Floddathat conductedcli/ cal trials of new drdgs forphnnnaceutical compnnies and other

SPOnSOrS.

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12. DefendantANG ELA M ARIA GIRON wasaresidentofM iami,Floridaandwas

theclinicalinvestigatorfortheCDAD clinicaltrial.

Co-conspirator 1wasaresidentofM iam i,Flodda.Co-conspirator1wasthecoownerofAM B ResearchCenterandservedasitsVice-president/Director,P. residentD irector,lead

sm dycoordinator,clinicalresearch coordinator,andstudy coordinator.

14. Co-conspirator2 wasaresidentofM inmi,Florida.Co-conspirator2wasthecoowner of AM B Research Center and served as itsVice-president/Director,clinicalresearch

coordinator,andstudycoordinator.

15. Co-conspirator3 wasaresidentofM inm i,Florida.Co-conspirator3 served as

recruitinganddataentry specialist,sitemanager,andphnnnacistatAM B Research Center.

TheClinicalTrial

16. Co-conspirator 1,Co-conspirator 2,and Co-conspirator 3 conducted various

clinicalttialson behalfofsponsorsand CROslocated throughoutthe United States atAM B

ResearchCenter.

In oraround M arch 2016,AM B Research Centerwas contracted to condud a

clinicaltrialdesigned to evaluatethesafety and effkacy ofan investigationaldrug intendedto

treatpersonswithClostridillm diftk ile-associateddiarrhea.

18. Priorto beginning the CDAD clinicaltrial,Co-conspirator1,on behalfofAM B

Research Center,entered into a ttclirlicalTrialAgreement''with the CRO and sponsor. The

ClinicalTrialAgreem entrequired,nm ongotherthings,thatAM B Research Centerconductthe

CDAD dinicaltrialinstrictaccordancewiththeClinicalTrialAgreementandstudyprotocol.The

Clirlical TzialAgreem ent also required AM B Research Center and any persons or entities

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performing serviceson itsbehalfto actin accordance and compliance with allapplicableFDA

regulations.

TheClinicalTrialAgreem entrequiredAM B Research Centerto obtain informed

consentf'rom subjectstoparticipateintheCDAD clinicaltrial,andtonotifytheCRO,sponsor,

andInstimtionalReview Boardinm itingofanydeviationsfrom thestudyprotocolandtoreview

a11casereportform sandcasehistoriesforaccm acyand completeness.

20. Thestudyprotocolrequiredsubjectstomeetcertaineligibilitycriteriatobeemolled

intheCDAD clinicaltrial.Forexample,amongotherthings,thesttzdyprotocolreqtliredsubjects

to have a diagnosisofmild-m oderate orsevere CDAD;firstocc= ence orfirstrecurrence of

CDAD within three monthsofenrollm entand diarrhea within 24 holzrspriorto enrollment;a

positiveClostridillm dix ciletestandstooltestfrom thesnm estoolsnmplecollectednomorethan

72 holzrs prior to enrollm ent;and signed written irlform ed consent forms before any studym andatedprocedlzrecouldbeconducted.

21. Thesttldyprotocplcontainedexclusioncdteriathatprollibitedinvestigationalstaff

sitemem bersortheirrelativesfrom participatingintheCDAD clirlicaltrial.

22. The smdy protocolrequired each subjectto be assigned a lmique subject

identification mlmber. The clinicalinvestigator/delegate was required to keep a subject

identifkationcodelistshowingthesubject'snsme,dateofbirth,address,oranyotherlocaly

acceptedidentifiers.

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23. ThestudyprotocolrequiredsubjectsparticipatingintheCDAD clinicaltrialto

completeastooldiary,aCDAD DaysymsProQuestionnaire,aquestipzmaireentitledçGW ork

ProductandActivitylmpairment:CDAD,''andasmdydrugjournal.Thesubjectswererequired

toprovidethetwocompletedquestiormaires,stooldiary,andstudydrugjournaltoAMBResearch

Center,from whichAM B ResearchCenterwasrequiredtoenterthedataintheappropriatestudy

database.

24. The ClinicalTrialAgreem entbetween AM B Research Center,the CRO,and

sponsorincludedabudgetandscheduleofpaymentsthesponsorwouldpayAM B ResearchCenter

perenroledsubject,providedthatAMBResearchCenter'sserviceswereproperlyperformedin

accordancewiththestudyprotocolandtheClinicalTrialAgreem ent.Thescheduleofpayments

in the ClinicalTrialAgreem entincluded each informed consent,exnmination,procedure,test,

CDAD questionnaire,officevisit,interview,orothereventrequiredlmderthestudy protocol,in

addition to otherfeesand conditionalprocedures.The ClinicalTrialAgreem entalso included

paymentsthesponsorwouldpayAMBResearchCenterforscreenfailedsubjectsfoundineligible

toparticipateintheCDAD dinicaltrial,including applicablevisitfeesperformedin accordalw e

withthestudyprotocol.TheClii calTrialAgreementrequiredthatAM B Research Centernotbe

paidforsubjectswhowereenroledwithoutaproperlyexecutedconsentform andwhodidnot

m eeteligibility andexclusioncriteria.

25. TheClinicalTrialAgreementandstudym otocolrequiredAM B Reserch Center,

intlrn,topayindividualsubjectsfortravelcostsnottoexceed$120.00peremolledsubjectin

accordancewith thestudyprotocolscheduled visit. Reimblzrsementforsubjecttravelcosts

exceeding$120.00requiredptiorwrittenapprovalfrom theCRO orsponsor.

26. TheClinicalTrialAgreementprovidedforsubjectstipend/compensationtobepaid

toAM B Research Centeron aquarterlyb:sisbasedoncompletedvisits.PtlrsuanttotheClinical

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TrialAgreem ent,AM B Reserch Centerwasrequiredtuprom ptlyrefundtotheCRO anypatient

stipend/compensationpaidbytheCRO toAM B ResearchCenterthatwasnotacm allypaidtothe

subject.

TheClinicalTdalAgreem entrequiredAM B ResearchCentertoberesponsiblefor

com pensatingallotherentitiesandindividualsinvolved inconductingthestudy.

COUNT I

Conspiracy

(18U.S.C.j371)

TheGeneralAllegationssection oftllisIntbnnation isre-allegedandincorporated

asthoughfullysetforthherein.

2. Beginning in orarotmd September2015,and continuing atleastthrough in or

arotmdM arch2018,inM iam i-DadeCounty,intheSouthernDistrictofFloddaandelsewhere,the

defendant,

ANGELA M ARIA GIRON,

didwillfully,thatis,withtheintenttofurthertheobjedoftheconspiracy,andknowinglyeombine,

conspire,confederate,andagreewithCo-conspirator1,Co-conspirator2,Co-Conspirator3,and

othersktlownandImknowntotheUnited StatesAttorney,tocomm itanoffenseagainsttheUnited

States,thatis:toknow ingly,andwiththeintenttodefraud,deviseandintendtodeviseascheme

and artifice to defraud and to obtain money and property by m eans ofm aterially false and

fraudulentpretenses,represenGtions,andprom ises,knowingthatthepretenses,representations,

andpromiseswerefalseandfraudulentwhenmade,and,forthepurposeofexecutingthescheme

andartitk e,didtransmitandcausetobetransmitted,bym eansofwirecom municationininterstate

andforeigncomm erce,certainm itings,signs,signals,pictures,and sounds,in violationofTitle

18,United StatesCode,Section 1343.

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PURPOSE OF TH E CONSPIM CY

Itwmsthepurposeoftheconspiracy forANGELA M ARIA GIRON andhercod

conspiratorstolnlawfuly emichthemselvesby,nmongotherthings:(a)secudngcontractsto

conducttheCDAD clinicaltdal;(b)fabricatingandfalsifyingdoclzments,studydata,andother

itemsrelatedtotheCDAD clinicaltrialtoobtainpaymentsandinflatethepaym entsdueandowing

toANGELA M ARIA GIRON andherco-conspiratorslmdertheClinicalTrialAgreement;(c)

receiving paym ent for the CDAD clinical trial by m aldng material false and fraudulent

representations;mld(d)usingthefraudulentlyobtainedftmdsforthedefendant'spersonaluseand

benetk,theuseandbenefk ofothers,andtofurthertheconspiracy.

M ANNER AND M EANSOF TIIE CONSPM CY

Them annerand m eansby which ANGELA M ARIA GIRON and herco-conspirators

soughttoaccomplishtheobjectandpurposeoftheconspiracy,nmongothers,thefolowing:

4. ANGELA M ARIA G IRON andherco-conspiratorscreatedfalseandfraudulent

study subjectsusing the personalidentitkation information ofnon-smdy participants and

othem iseineligibleindividuals,andsubm itledtheinformationassociatedwiththepurportedstudy

subjectstotheCDAD clinicaltrialdatabasesystemsinordertoinducetheCRO,adingonbehalf

ofthesponsor,tom akepaymentstoAM B Research Centertowhichitwasnotentitled.

5. ln order to prevent the sponsor,the CRO,and the FDA from lenrning that

ANGELA M ARI'A GIRON and herco-conspiratorscreated false and âaudulentdata forthe

CDAD clinicaltrialand subm itted falseandfraudulentdatatotheCDAD cliniealtdaldatabase

system s,ANGELA M ARIA GIRON andherco-conspiratorscreatedfalseandgaudulentcase

Mstories,laboratorytests,andsubjectstudydocumentsofthepurportedstudysubjectstomakeit

appearthatthesubjectshad,nmongotherthings,satisfiedtheeligibilitycdteriatoparticipatein

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theCDAD clinicaltrial,signed informed consentformsin thepresenceofANGELA M ARIA

GIRON toparticipatein theCDAD clinicaltrial,signed informed consentform sinthepresence

of the clinical investigator to participate in the CDAD clinical trial,received a physical

exnm ination, provided laboratory samples,received and had taken the study m edication,

completedthehandwrittenquestiormaires,studydnlgjotmlals,andstool dinries,andreceived

paym entforvisitstoAM B Research CenteraspartoftheCDAD clinicaltrial.

6. AN GELA M ARIA GIRON and her co-conspirators falsely and fraudulently

represented thatANGELA M ARIA GIR ON obtained inform ed consent9om a11purported

subjects,asrequiredbythesttzdyprotocol,tobeincludedintheCDAD clinicaltrial.

7. AspartoftheirefforttoconcealthefactthatAM B Research Centerfalsifiedsttzdy

data,Co-conspirator1sentandreceivedemailsonbehalfofAM B ResearchCenterregardingthe

CDAD clinicaltrial.

8. As a resultofthe false and fraudulentmisrepresentationsm ade by ANGELA

MARIA GIRON andherco-conspirators,theCRO,actingonbehal?ofthesponsor,paidAMB

ResearchCentertoconducttheCDAD clinicaltrial.Thereafter,M GELA M ARIA GIRO N and

herco-conspiratorsusedthefundsfortheirpersonaluseandbenefit,theuseandbenefitofothers,

andtofurthertheconspiracy.

9. Toinducethesponsorand/ortheCRO toenterintoaClilzicalTrialAgreem entwith

andm ovidem oney toANGELA M ARIA GIRON andherco-conspirators,ANGELA M ARIA

GIRON andherco-conspiratorsm adeandcausedotherstom akentlm erousm ateriallyfalseand

fraudulentstatementstothesponsor,theCRO,and/ortheFDA .

OVERT ACTS

Infurtheranceoftheconspiracy,andtoaccomplish,theobjectandpurposethereof,atleast

oneofthefollowing acts,am ongothers,werecomm ittedintheSouthern DistrictofFlorida,and

9

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elsewhere,by atleastoneco-conspirator:

1. ANGELA M ARIA GIRON and Co-conspirator 1 signed a letterdated M ay 7,

2017, addressed to the Institutional Review Board, which contained false and âaudulent

misrepresentations,includingthatANGELA M ARIA GIRON waspresentfora11subjects'

informedconsentandgaveeachsubjectthetimetounderstand,read,andresolveanyquestions

priorto signingtheinform edconsentform .

On M ay 8,2017,Co-conspirator 1em ailed thatletterto theInstitutionalReview

BoardaydcopiedANGELA M ARIA GIRON.

On October2,2017,Co-conspirator1sentanelectronicm ailcomm tmicationto an

em ployeeoftheCRO requesting AM B Research Center'sfinalCDAD clinicaltrialsitepaym çnt

wlzichwasbasedonandincludedpaymentsforsubjectswhodidnotparticipateintheCDAD

clinicaltrialincom pliancewiththesm dyprotocol.

A11inviolationofTitle18,UnitedStatesCode,Section 371.

FORFEITURE

(18U.S.C.j981(a)(1)(C))

Theallegationsofthislnformationareherebyre-allegedandbytbisreferencefully

incorporatedherein forthepurposeofallegingcrim inalforfeituretotheUnitedStatesofAm erica

ofcertainpropertyinwhichthedefendant,ANGELA M ARIA G IRON,hasan interest.

2. Upon conviction ofaviolation ofTitle 18,Ulzited StatesCode,Section 371,as

alleged in thisInform ation,the defendantshallforfeitto the United States ofAmedca,any

property,realorpersonal,wlzichconstitutes,orisderivedf'rom proceedst'raceabletosuchoffense

plzrsuanttoTitle18,UrlitedStatesCode,Section981(a)(1)(C).

3. Thepropertysubjecttoforfeitlzreasaresultoftheallegedoffenseincludes,butis

notlim itedto,astlm ofmoneyequalinvaluetothetotalnmountofproceedsthedefendantderived

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from theoffenseandfundsinvolvedinorderived from theallegedoffense,andm ay besoughtas

aforfeituremoneyjudgment.

4. Ifanyofthepropertysubjecttoforfeitlzre,asaresultofanyactoromissionofthe

defendant:

a. cnnnotbelocatedupontheexerciseôfduediligence;

b. hmsbeentransferredorsoldto,ordepositedwith,athirdperson;

hasbeenplacedbeyondthejtlrisdictionoftheCourt;

hasbeen substantiallydimizlishedinvalue;or

has been comm ingled with otherproperty which cannotbe subdivided without

diffculty,

theUnhed Statesshallbe entitledto theforfeitm eofsubstitm eproperty undertheprovisionsof

Title21,UnitedStatesCode,Sedion853(1$.

UnitedStatesCode,Section981(a)(1)(C),andtheprocedtzres

forthatTitle21,UnitedStatesCode,Section853,a incorpo tedbyTitle28,U ' StatesCod

Y X ' *

AN ANTONIO GO ALEZ

TED STATESA ORNEY

AllpursuanttoTitle 18,

GUSTAV W .ELDER

DHG CTOR

U.S.DEPARTSG NT OFAJSX CE

CON SUSG R PROTECTION BRANCH

- 0

KARI, -DEE CLARK

JESSICA C.HARVEY

TRIAT.AU ORNEYS

U.S.DEPARTX NT OFJUSTICE

CON SUW R PROTECTION BRAN CH

11

k

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UM TED STATESOF AM ERICA

V.

ANGELA M ARIA GIRON,

/

Defendant.

CourtDivision(selectone)

Z Miami L KeyW est Q FTP

L.FTL L W PB

IJNITED STATESDISTRICT COURT

SOUTHERN DISTRICT OF FLORIDA

CASE NO.:

CERTIFICATE OF TIUAL ATTORNEY *

SupersedingCaseInform ation:

New Defendantts)(YesorNo)

NumberofNew Defendants

TotalnumberofNew Counts

1doherebycertifythat:

1. 1havecarefully consideredtheallegationsoftheindictment,thenumberofdefendants,the numberofprobable

wimessesandthelegalcomplexitiesoftheIndictment/lnformationattachedhereto.

Iam awarethattheinformationsuppliedonthisstatem entwillberelieduponbytheJudgesofthisCourtinsetting

theircalendarsandschedulingcriminaltrialsunderthemandateoftheSpeedyTrialAct,Title28U.S.C.j3161.

3 lnterpreter:(YesorNo)YeS

Listlanguageand/ordialect:Spanish

4. Thiscasewilltake 0 daysforthepartiestotl'y.

Pleasecheckappropriatecategoryandtypeofoffenselistedbelow:

(Checkonlyone) (Checkonlyone)

l Z 0to 5days EIPety

11 L 6to10days L'M inor

Il1 L 11to20days LiM isdemeanor

IV 121to60days E!Felony

V Q'61daysandover

6. HasthiscasebeenpreviouslyfiledinthisDistrictCourt?(YesorNo)No

lfyes,Judge CaseNo.

Hasacomplaintbeenfiledinthismatter?(YesorNo)No

Ifyes,M agistrateCaseNo.

B. DoesthiscaserelatetoapreviouslyfiledmatterinthisDistrictCourt?(YesorNo)Yes

lfyes,Judge M oore CaseNo. 22-20431-CR (SEALED)

9. Defendantts)infederalcustodyasof

10. Defendantts)instatecustodyasof

11. Rule20from the Districtof

12. lsthisapotentialdeathpenaltycase?(YesorNo)No

13. Doesthiscaseoriginatefrom amatterpendingintheNorthernRegionoftheU.S.Attorney'sOffice

priortoAugust8,2014(M ag.JudgeShaniekM aynard?(YesorNo)No

14. Doesthiscaseoriginatefrom amatterpendingintheCentralRegionoftheU.S.Attorney'sOffice

priortoOctober3,2019(Mag.JudgeJaredStrauss?(YesorNolNo

By: tz

KARLA-DEE CLARK

DOJTrialAttorney

CourtID No. A5502714

Case 1:22-cr-20471-KMW Document 3 Entered on FLSD Docket 09/30/2022 Page 12 of 14
UNITED STATES DISTRICT COURT

SOUTHERN DINTRICT OF FLORIDA

PENALTY SHEET

Defendant's Nam e: ANGELA M ARIA G IRON

C ase N o: '

Count #:

Title 18. United States Code. Section 371 .

Conspiracy

* M ax. Term of Im prisonm ent: 5 years

* M andatory M in. Term of Imprisonment (if applicable): N/A

* M ax. Supervised Release: 3 years

* M ax. Fine: $250,000 or twice the gross gain or loss from the offense

frR efers only to possible term of incarceration, supervised release and llnes. It does not include

restitutiom special assessm ents, parole term s, or forfeitures that m ay be applicable.

Case 1:22-cr-20471-KMW Document 3 Entered on FLSD Docket 09/30/2022 Page 13 of 14
A0 455 (Rev. 01/09) Waiver of an Indictment

U NITED STATES D ISTRICT C OURT

for the

Southern District of Florida

United States of America

Case No.

Angela Maria Giron,

Depndant

W AIVER OF AN INDICTM ENT

1 understand that I have been accused of Une or m ore offenses punishable by im prisonm ent for more than 0ne

year. l was advised in open coullof my rights and the nature of the proposed charges against me.

After receiving this advice, 1 waive my right to prosecution by indictment and consent to prosecution by

information.

Defendant 's signature

Signature ofdefendant 's attorney

Printed name ofdefendant '.ç attorney

Judge 's signature

Judge 'sprinted name and title

22-20471-CR-WILLIAMS/MCALILEY

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