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PhenoPathDiagnoses you can count on®
Diagnoses you can count on®www.phenopath.com
henoPath provides anatomic pathology services for Phase I–III clinical trials. Our team adapts its service delivery to reflect your project design, management and implementation requirements.
PhenoPath is experienced in working with third-party vendors to ensure timely and trackable specimen management, either directly from sponsor sites or another CRO.
PhenoPath understands the need for timely results on entrance criteria testing, and provides rapid turnaround time for biomarker-testing assays. Board-certified pathologists and/or scientists evaluate all assays. Report formats are customizable to reflect either individual case or cumulative case formats.
PATHOLOGY SERVICES
DIAGNOSIS & INTERPRETATION• Solidtumordiagnosisandsubtyping,includingbreast,colon,lung,sarcoma,etc.• Hematopathologydiagnosisandsubtypingincluding,lymphoid,myeloid,plasmacelldisorders,etc.• Tissuebiomarkerquantification,includingflowcytometry,immunohistochemistry(IHC),immunofluorescence(IF),
cytogenetics,fluorescencein situhybridization(FISH),chromogenicin situhybridization(CISH),DNA/RNAin situhybridization(ISH),andpolymerasechainreaction(PCR)
• Tissuemacrodissectionfordownstreamassay(s)• Tissuemicroarrayconstruction• Over450testsavailable
EXPERT CONSULTATION• Consultationontherapeutictargetselectionandquantificationinthepre-clinicalsetting• Consultationonallpathology-relatedaspectsofclinicaltrialdesign,includingoptimizedtherapeutictargetquantification• Secondopinionconsultationoncomplexcases,includingclinicalcorrelation
CONTINUOUS EDUCATION• PhenoPathpathologistsfollowthelatestdevelopmentsincancerdiagnosisandtreatment• PhenoPathpathologistspublishextensivelyinscientificpeer-reviewedjournals• PhenoPathPathology Reference Guideavailable• PhenoPathpathologistsareavailabletopresenton-siteatinvestigatormeetings
ENTRANCE & ENROLLMENT
RAPID ENTRANCE CRITERIA SCREENING• Rapidpathologytestingandevaluationbyboard-certifiedpathologistsandscientists• Closecoordinationwitheachsponsor's clinicaltrialorganizers
REPORTING CAPABILITIES• Customreportformats• Scalableandconfigurableresultsreportingdatabase• Virtualpathologyreportingcapabilities• Secureandencrypteddatatransferandarchiving
SPECIMEN MANAGEMENT• End-to-endspecimenacquisitionandtracking• Rapid-turnaroundtimeforenrollmentcriteria
CLINICAL TRIALS
PD-L1 by IHC
PP
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vNov2015
PhenoPathDiagnoses you can count on®
SOLID TUMOR PATHOLOGY HEMATOPATHOLOGY
Diagnosisandsubtyping(breast,colon,lung,sarcoma,etc.) IndolentBcellnon-Hodgkinlymphoma
Undifferentiatedmalignantneoplasms Prognosticandpredictivemarkers
Carcinomasofunknownprimarysite AggressiveBcellnon-Hodgkinlymphoma
Spindlecelltumors/sarcomasubtyping Tcellnon-Hodgkinlymphoma
Mesotheliomavs.adenocarcinoma Lymphoblasticleukemia/lymphoma
Small,blue,roundcelltumors Hodgkinlymphoma
Germcellneoplasms Plasmacellneoplasms
Skinandmucosalimmunofluorescencestudies Acutemyeloidleukemias
Chronicmyeloidneoplasms(MDS&MPN) Rarehematolymphoidneoplasms
Hydatidiformmoleevaluation Benignhematolymphoidproliferations
Amyloidsubtyping
• PhenoPathhasanindependent,on-siteQualityAssuranceUnit(QAU)withseveraldecadesofcombinedexperienceinCLIA,GLPandGCPenvironments
• ComprehensiveQualityManagementSystem,including:» AllprocessesgovernedbySOPs» Changecontrolprocess» Proceduresforpreventativeandcorrectiveactions(CAPA)» Qualitymetrics» Competencyassessmentsoftechnicalstaff
REGULATORY COMPLIANCE• CAPaccreditationforhigh-complexitytestingunderCLIA• LicensedlaboratoryinCA,FL,MD,NY*,RI,andWA(*subset of services)• StudiesperformedinaccordancewithGLP/GCP,asapplicable• ClinicalTrialactivitiesatPhenoPathwillbeconductedaccordingtoPhenoPath'sStandardOperatingProcedure(SOPs)and
thefollowing:» ICHGuidelineforGoodClinicalPractice(E6)» GoodClinicalLaboratoryPracticesasoutlinedintheWHO"GoodClinicalLaboratoryPracticesGuideline"» EuropeanMedicinesAgency(EMA)"ReflectionPaperforLaboratoriesthatPerformtheAnalysisorEvaluationofClinicalTrialSpecimens."
EXPERTISE
QUALITY
IMP3 by IHC
If you would like more information about PhenoPath's BioPharma services, please visit our web site at www.phenopath.com, contact any of our pathologists (888-927-4366), or contact your sales representative to request a quote.