musculoskeletal clinical regulatory … · ... clinical project management; data management; ......

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Services Brochure

The Leading Neuro-Musculoskeletal Consulting Firm

Washington, DC • New York, NY • Hartford, CT

Regulatory • Reimbursement • Clinical • Manufacturing Quality Assurance • Healthcare Compliance • Intellectual Property

MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS, LLC

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Proprietary Service Offerings

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MCRA Services

Overview

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Regulatory

Clinical/CRO

Quality Assurance

Health Economics, Reimbursement, & Public Policy

Healthcare Compliance

Intellectual Property

Company Profile

Neuro-Musculoskeletal Industry Focus

Global Footprint

Services

Clientele

Management Team

Track Record

Publication Leadership

Due Diligence

Compliance & Business Ethics Hotline

Clinical Trial Reimbursement Solutions

Health Economic and Value Messaging

Notes


TABLE OF CONTENTS

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Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a highly specialized, independently operated consulting firm serving the worldwide orthopedic industry. MCRA is a group of leading strategists committed to integrating regulatory, clinical,

intellectual property (IP), reimbursement, quality assurance, and healthcare compliance strategies to facilitate successful value creation for our clients. Founded in 2003, the firm provides “first-in-class” service to its clients through its superior knowledge base, global surgeon relationships, and deeply experienced management team. MCRA places particular emphasis on its expertise working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.

OVERVIEW

Company Profile

Neuro-Musculoskeletal Industry Focus

Diagnostics

Medical Instruments

Biologics

Pharma

Medical Devices

Capital Goods

Biotech

Services

Global Footprint

Brain

Teeth

Spine

Skin

Bone

Muscle

Nerve

Cartilage

Tendon

Ligament

• Australia• Belgium• Canada• China• Denmark• Finland• France• Germany• Ireland• Israel• Italy

• Japan• Malaysia• NewZealand• SouthAfrica• SouthKorea• Sweden• Switzerland• TheNetherlands• UK• USA

Countries

8 Niche Markets

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MCRA merges best-in-class consulting practices from identification and evaluation to planning and execution to create a one-stop shop for healthcare clients. MCRA offers a complete suite of services including:

Services

Clientele

Regulatory

Reimbursement

Clinical


Healthcare Compliance

Quality Assurance

• Regulatory: Keyservicesinclude:FDAsubmissions(IDE/PMA,IND/BLA,510(k),HDE,PDP);strategy,analysisandimplementation;designandreviewpre-clinicaltesting; clinicaltrialprotocoldevelopment.

• Clinical:Keyservicesinclude:clinicalstudy;siteandsurgeonidentification;sitequalificationandinitiation;siteandstafftraining;clinicalprojectmanagement; datamanagement;sitemanagementandstudymonitoring.

• Reimbursement: Keyservicesinclude:strategicplanning;codingandadd-onpaymentapplications; healthcarepolicydevelopment;utilizationanalyses,predictiveeconomic utilizationmodelingandcodinghotlines.

• Healthcare Compliance: Keyservicesinclude:complianceprogramdevelopment;businessethicstraining; sanctionscreening;hotlinemanagement;audits&investigations;patientprivacy; conflictofinterestmanagement;andcomplianceprogramoutsourcing.

• Intellectual Property: Keyservicesinclude:clearance/freedom-to-operatesearches;competitivepatent landscapes;patentability/noveltysearches;productortechnologyduediligence; andinvaliditysearches.Keyproductsinclude:patentlandscapemaps;patent databases;patentabilitymatrices;andexpertanalysisreports.

• Quality Assurance: Keyserviceareasinclude:QualitySystemRegulation(QSR);technicalsupport andriskmanagement;designcontrols;audits;problemresolution;supplier management;manufacturing;andemployeetraining.

Spine

Orthobiologics

Law Firms

General Orthopedics

Sports Medicine

Trauma

Other Medical Technology Niches

Other

Small Bone Surgeons Mfg. Financial

>275 Clients

31%

15%

10%

8%

7%

7%

6%

5%

4%2%

2%2%

Other Medical Technology Niches• Cardiovascular

• Dental

• Obesity

• ImagingDiagnostics

• PainManagement

• DataManagement

4 Neuro-Musculoskeletal Anatomies• Cranio-Maxillofacial

• Spine

• SmallBone&Joint

• LargeBone&Joint

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OVERVIEW

Management Team

Track Record

MCRA’s Management Team has more than 100 years of combined experience from the healthcare industry’s largest companies, global manufacturers, financial institutions, government agencies, consulting firms, and insurance institutions. Sample biographical highlights of MCRA’s management team include experience in positions such as:


US Regulatory Approvals, Clearances & Exemptions

Quality Assurance & International Regulatory

Industry Relations

Health Economics, Reimbursement & Public Policy

> 400 Patents > 240 Trademarks

14 PMAs 75 IDEs > 1,000 510(k)s

>210 Audits Passed 16 GMP Systems Implemented 12 IDE Audits

> 400 Unique Clients > 900 Distributors (2011) > 7,000 Physicians Trained

112 Coverage Conversion 24 Landscape Assessments 74 Hotline & PAM Activities

341 Trial Reimbursements 36 Health Economic Transactions 15 New Product Codes

44 Reimbursement Strategies 54 Due Diligence Activities 85 Coding Activities

MCRA has extensive experience and success bringing Class II and Class III medical devices to market. Our regulatory team has reviewed over 1,000 regulatory submissions; our clinical team has written, advised, and/or monitored approximately 100 various studies for the orthopedic market; our intellectual property experts have examined, drafted, prosecuted, and prepared pre-litigation materials for over 220 issued orthopedic-specific patents and/or patent applications; and our reimbursement team has led over 1,200 healthcare economic-related initiatives.

• USFDABranchChiefofOrthopedicDevices

• LeadReviewers,Orthopedic&Spinal,FDA

• MembersofDepartmentofHealth&HumanServices

• VicePresidentofClinicalandMedicalAffairs,MedtronicSpine

• USPatent&TrademarkOfficeExaminers

• MemberofCenterforMedicare&MedicaidServices(CMS)

• MedicalDirectorofTop5InsuranceCompanies

• Board-CertifiedOrthopedicSurgeons

• NASSBoardofDirectors&ExecutiveCommittee

• QualitySystems&InternationalRegulatoryExperts

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Publication Leadership

MCRA is focused on disseminating scientific studies, industry intelligence, and trend analyses within the neuromusculoskeletal industry. We strive to be your primary source for regulatory, reimbursement, clinical, intellectual property, quality assurance, and healthcare compliance information. MCRA’s sample reports and industry intelligence are available on our website at www.mcra.com. New materials are released as they are published.

White Papers • Peer Review Journals • Newsletters • Industry Research

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MCRAServices


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MCRA’s Regulatory department has substantial experience guiding musculoskeletal technologies

through FDA approval at all points of the device life-cycle: from strategy and pre-clinical testing, to FDA submission, market approval, and post commercialization.

MCRA combines vast neuro-musculoskeletal industry knowledge with nearly 30 years of FDA experience. We leverage data generated through mechanical, animal, or clinical testing with unrivaled competitive knowledge making MCRA the most experienced team to advise and execute your regulatory strategies.

REGULATORY

Core Regulatory Services

Submissions with Direct Knowledge of FDA’s Mindset

• 510(k),IDE,PMA,IND,BLA,HDE

• Pre-IDE/BLA,Day100,&PanelMeetings

Strategy, Analysis, & Development

• PredicateLandscape&DeviceDesign

• OptimizeApprovedIndications,Data&Claims toGainCompetitiveAdvantage

• LeverageRegulations,CompetitionNewOpportunities

Design, Review, & Pre-Clinical Testing

• Mechanical,Biocompatibility,Biomechanical,&Animal

Other Services

• AnnualUpdatesforPMA,BLA,&HDEDevices;

• NewProductAcquisitions&TransferofOwnership

• AdverseEventReporting

• SiteRegistrations

• DeviceListing

• USAgentforForeignCompanies

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CLINICAL/CRO

MCRA’s unique Clinical Research Organization (CRO) enables international and US-based or-

thopedic companies to successfully execute clinical studies. Our philosophy is to streamline the clini-cal trial process by utilizing our unique, integrated approach to guide you through the medical device lifecycle. MCRA’s expertise is unmatched, while our cross-services integration is positioned to optimize quality, cost, and time.

MCRA’s CRO uses dedicated experts to actively manage our statisticians, investigators, and IRB’s, leading to faster enrollment and high success rates. Our orthopedic expertise, coupled with our global surgeon relationships, makes MCRA a valuable musculoskeletal clinical research organization that will get your product to market on time and on bud-get. MCRA’s professionals have 35 + years of com-bined experience dedicated exclusively to the clinical study arena.

Core Clinical ServicesClinical Study & Regulatory Submission Preparation

• StudyProtocol&BudgetDevelopment

• RetrospectiveClinicalDataCompilation

• LiteratureSearches&Analysis

• InvestigatorSelection

• CompileIRBPackets,CoordinateIRBApprovals,CompileInvestigatorBrochures

• ConsistentCaseReportForms

Clinical Study Management

• ManageDataEntry&AnalysisThroughSubcontractwithCROs

• ManageSiteTrainings&MonitorSiteStatusReports

• NegotiateIRBApprovals

• PerformStudyStatisticsAnalysis

• WriteFinalClinicalStudyReportforSubmission

Post Clinical Studies

• “Ghostwriting”forPeer-ReviewedMedicalJournals,Whitepapers,PowerPointPresentations,&AbstractsforUS&InternationalMedicalConferences

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QUALITY ASSURANCE

MCRA assists orthopedic companies in achieving regulatory and standard compliance

with U.S., European, and Canadian agencies and organizations. MCRA’s integrated services enable a streamlined U.S. and International regulatory strategy to optimize commercialization and validation processes.

Navigating the complex differences between U.S., European, and other international quality system regulations is often overlooked, yet extremely important to successful commercialization. MCRA’s services uniquely cater to large and small companies to streamline procedures and enhance efficiencies.

Core Quality Assurance

Quality System Creation/Modification/ Implementation

• ComplianceAssessment

• FDAQSR,ISO13485,EuropeanMedicalDeviceDirective;CanadianMedicalDeviceRegulation

• UniformApproachforUS&InternationalStrategy Procedures

• CreateQualityManual;StandardOperating Procedures;WorkInstructions

• Internal&SupplierQualityAudits

• ReportsfromInternationalSubmissions

International Regulatory Affairs

• CEMarkApproval

• CreateorUpdateTechnicalFiles

• CreateDesignDossiers

• Obtain&MaintainDeviceLicenses

Personnel Training

• MDD,QSR,ISO13485,RiskManagement

• OtherServices

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HEALTH ECONOMICS, REIMBURSEMENT, & PUBLIC POLICY

MCRA’s Health Economics, Reimbursement, & Public Policy services guide orthopedic

technologies throughout the multiple healthcare economic pathways: from technology development to commercialization and beyond.

Active regulatory and clinical endeavors are essential to a successful reimbursement strategy. MCRA uniquely integrates six service lines to design all strategic initiatives to maximise the success of each individual component.

MCRA is the preeminent team for evaluating existing orthopedic technologies’ current coding, coverage, and payment options. Further, MCRA’s team can work to assist your company’s desires to affect trends and changes in healthcare policy.

Companies with an early stage technology will find MCRA’s integration imperative, while companies who have had complications in the past will find MCRA’s first-in-class musculoskeletal services invaluable.

Core Health, Economics, Reimbursement, & Public Policy Services

Strategic Reimbursement Services

• StrategicReimbursementPlanning• LandscapeAssessments• CoverageAdvocacyandPayerMessaging• CodingApplicationsandPayment

Management Support Services

• ClinicalTrialManagement• ClinicalTrialCoverage• CTADevelopmentandNegotiation• StudyProtocolReview

Hotline Support

• CompliancePlanning• CodingHotlines• PatientAccessManagement

Data Analytics

• CMSandCommercialClaimsDataAnalyses• MarketIntelligence• EconomicOutcomesAnalyses• UtilizationandEconomicOutcomeStudies

Sales Support

• CodingGuides• CodingHotlineServices• FacilityValueAnalysisServices

Patient Access Management Support

• PayerEducation&Messaging• Insurance&BenefitVerification• PriorAuthorization• CoverageDenialAppeals• IndependentReviewOrganizationAppeals• ClaimsReview&Appeals

Health Economics & Value Messaging

• HealthEconomicOutcomeStudies&WhitePaperDevelopment

• ValueMessaging&SalesAidContentDevelopment

• ValueAnalysis&FacultyPresentations

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HEALTHCARE COMPLIANCE

In today’s heavily regulated business environment it is imperative that healthcare companies implement

strong, effective compliance programs to promote ethical behavior and mitigate risks of non-compliance. Risks include fines, reputational damage, and personal liability for board members or senior executives, that adversly affect company performance.

MCRA’s extensive compliance service offerings, independent perspective, and industry insight allow us to work with our clients to create an ethically sound, fluid compliance program.

• ComplianceProgramDevelopment

• ComplianceProgramAssessment

• ComplianceProgramandBusinessEthicsTraining

• SanctionScreening

• InternalHotlineManagement

• Audits&Investigations

• PatientPrivacy

• ConflictofInterestManagement

• ComplianceProgramOutsourcing

• ComplianceManual

• AnnualComplianceTesting

Core Compliance Services

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INTELLECTUAL PROPERTY

MCRA’s Intellectual Property department pro-vides highly relevant and context-specific pat-

ent searches and IP analyses for law firms, compa-nies, independent surgeons, and inventors.

MCRA’s Intellectual Property suite of specialized services and products is particularly designed for the medical device industry and cannot be matched by general search firms. We work with clients at all stages of the product lifecycle to develop and execute the most appropriate, timely, and cost effective strat-egies necessary to protect your product and clear it for marketing. Additionally, we assist clients to build and optimize a patent portfolio that maximizes both short-term and long-term goals. Our IP services develop and navigate the competitive patent land-scape to identify potential infringement risks, patent trends, and/or value expansion opportunities.

What We Do: Featured Patent Services

• Clearance/Freedom-to-OperateSearches

• CompetitivePatentLandscapes

• Patentability/NoveltySearches

• ProductorTechnologyDueDiligence

• InvaliditySearches

What We Deliver: Featured Patent Products

• PatentLandscapeMaps:VisualAidforPresentation&StrategyDiscussions

• PatentDatabases:HighlyUsefulResourceforR&DandIPCounsel

• PatentabilityMatrices:ReferenceGuideforIPDevelopment

• ExpertAnalysisReports:FocusedResearchSummarized

• FormerUSPTOExaminersintheMedicalArt

• RegisteredPatentAgents

• OrthopedicIndustryExpertise

• AdvancedDegreesinBiomedicalEngineering

• Orthopedic:Joint,Large&SmallBone

• Spine

• Cardiovascular

• Tissue&Nerve

• SurgicalMethods

• SurgicalInstruments

Technology Expertise Unmatched Experience

Proprietary Service Offerings

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SSpecialized & Integrated For the Industry & Financial Community

DUE DILIGENCE

Regulatory • Clinical CRO • Quality Assurance • Reimbursement Healthcare Compliance • Intellectual Property

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• Challenge&TestUnderlyingBusiness&MarketAssumptions

• IndependentlyVerifyInformationPresented

• DevelopUnique&IndependentAnalyses

• PresentOpinionforManagement&Board

• Solutions-Oriented;CompetitiveAdvantage&Focus

• AssistonaGo-ForwardBasis

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MCRA’s Vision of Due Diligence The MCRA AdvantageFirst-In-Class Team

• Industry,FDA,CMS,Hospital,Insurance,&USPTOExperience

• Engineers,Attorneys,Statisticians,Scientists,Coders,&Clinicians

Experts in Neuro-Musculoskeletal

• Bone,Teeth,Skin,Muscle,Tendon,Ligament,Cartilage,Brain,SpinalCord,PeripheralNerves

Integrated Approach

• Regulatory,Reimbursement,Clinical,IntellectualProperty,QualityAssurance,Corporate/SurgeonEthics&Compliance

MCRA’s process for integrating the, “MCRA Advantage” creates un-paralleled benefits for its clients.

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Organizations committed to ethical and compliant behavior must ensure compliance issues are appropriately identified, investigated, and resolved. A confidential hotline that monitors compliance has been recognized as a best practice by government entities and is proven to be effective in identifying issues that may not otherwise have been identified. MCRA’s Compliance and Business Ethics Hotline provides a convenient way for employ-ees to learn about compliance policies and procedures, and to report issues.

MCRA’s Compliance and Business Ethics Hotline Helps Safeguard Company Operations,

Reputation, and Financial Performance

Cost effective, secure, customized web-based reporting solution Trained staff available during normal business hours through a toll free phone number

COMPLIANCE & BUSINESS ETHICS HOTLINE

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Report issue to the MCRA Compliance and Business Ethics Hotline

Issue received through the website or live operator

Individuals can choose to remain anonymous

Call details are provided to company for investigation

Issues are investigated, appropriately resolved, and communicated back to the MCRA Compliance and Business Ethics Hotline

The results are communicated with individuals via a confidential caller ID number

Individual with a compliance or ethics concern

MCRA’s Compliance and Business Ethics Hotline allows for identification, documentation, and resolution of compli-

ance issues. The hotline provides an additional reporting option for employees who may not be comfortable reporting a compli-ance issue via internal reporting procedures.

MCRA’s Compliance and Business Ethics Hotline Increases

the Probability of Implementing a Successful Compliance Program

MCRA Compliance Hotline Reporting Process

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CLINICAL TRIAL REIMBURSEMENT SOLUTIONS

•IntegratedClinicalTrialSupport

•CoverageDuringTrial

•CollectionofPayment&ClaimsInformation

•RealTimeReporting

•PostApprovalCommercializationSupport

You are working under financial, time, competitive, and regulatory constraints. Therefore, the rapid commercialization of your company’s technology is imperative.

Simultaneously, the medical reimbursement landscape is changing drastically, faster than regulatory or intellectual property law. MCRA believes the real question is not whether your technology will be approved by the FDA, but whether the United States commercial market will ultimately reimburse your technology.

Clinical data needed for a successful regulatory approval does not necessarily encompass the clinical data required for successful reimbursement of a technology. The common bond for bridging this gap is the design and collection of clinical data, which accounts for both regulatory and reimbursement considerations. We believe that these disparate needs can be solved with a well-planned, integrated regulatory and reimbursement strategy.

MCRA’s Clinical Trial Reimbursement Solution (CTRS) is designed to optimize parallel clinical trial data collection for reimbursement and regulatory initiatives. Whether your trial is in development or currently in enrollment, MCRA can offer our full suite of services or only select services to cater to your needs.

Parallel Data Collection for Reimbursement & Regulatory Initiative

• OptimizeValueCreation

• InsureCapitalInvestment

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Clinical Trial Support

Byintegratingreimbursementearlyinthetrialdesign,MCRA’sCTRSisabletoadvisecompanymanagement,sites,andpayersbyofferingstrategicandadministrativesupport to remove theburden fromclinical sitesandexpedite the clinical trial. Specifically, these servicesareasfollows:

• Analyze&FacilitateStudySiteDevelopment

• ClinicalTrialAgreements–Assess&Negotiate

• CounselforCurrentCodesApplicable

• ProduceCollateralReimbursementTools–ForSites&Sponsors

• Coding,Coverage&PaymentStudySupport–ForSites’&Investigators’BillingStaff

• ImplementPublicationPortfolioStrategy

Coverage During the Trial

MCRA secures coverage during the trial to ensurepayments.Keyvalue-addincludes:

• SpeedFutureSalesCyclebyCoverageDuringTrial

• EstablishPrecedentSettingCoverageNOW

• EarlyPayerIntegration

• OffsetClinicalTrialCosts–HavingyourTechnologyPotentiallyPaidFor

Collection of Payment & Claims Information

Efficienthandlingofclaimsandpaymentinformationdrivessuccessfulreimbursementduringclinicaltrials.Servicesinclude:

• LeverageLevelIClinicalData–CreationofanOptimalCodingSolution–FutureRVUAssignments

• ManageDatawithMCRA’sProprietary

• ReimbursementDatabase

• MarketIntelligence–WhoIsPaying?–HowMuch?

Real Time Reporting

Real time reporting offers control and transparencyto gauge day-to-day activity and report criticalinformationto:

• Management

• BoardofDirectors

• Investors

PostApprovalCommercializationSupport

Thedatabeingcollectedduringaclinicaltrialprovidesmarket intelligence and, more importantly, buildsthe case for future payer coverage decisions. Theseservicesinclude:

• SocietyEndorsements–CoverageSupport&PositionStatements–SupportingPermanentCPT-4Coding

• DriveCMStoAction–EnsureAppropriateDRG&APCMapping

• ExecutePayerAdoptionofYourTechnology–AddressingtheDisease&TreatmentOptions

• IntegrationoftheTechnology–WithinLocalUseProtocols

SStrategic & Administrative Support

Innovations in Medical Technology Demand Value Messaging

Health Economic Outcome Studies & White Paper Development• ProspectiveHealthEconomicOutcomeStudies

• RetrospectiveClinical&EconomicOutcomeReviews

• HistoricalClaimsDataMining&PredictiveModeling

• Utility(QALY,HRQOL)Analyses&ValuePublications

Value Messaging & Sales Aid Content Development • SuccinctContentforusebyCompanytoCommunicateMessage

• CollateralMaterialDevelopmentforUsebySales&MarketingStaff

• DirectedCommunicationstoFacilityAdministrators&Prescribers

Value Analysis & Faculty Presentations • Hospital&HealthSystemValueAnalysisPresentations

• GPOandGroupContractingSupportServices

Valuemessaginghasbecome

acriticalcomponentofsales&

technologyadoption.Integration

ofreimbursementvaluedrivers

withinclinicaltrialsalongwith

independenthealtheconomic

studiesdistinguishestechnologies

&treatmentoptions.

HOW WILL YOUR MEDICAL DEVICE OR BIOLOGIC DEMONSTRATE ITS VALUE?

HEALTH ECONOMIC & VALUE MESSAGING

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Why Health Economics Are Important

• Coding,Coverage,andPaymentDecisionsAreImpactedbyHealthEconomicOutcomes

• PurchasingAgentsemphasizecomparisonsbetweenproductpricingandvalue

• ReimbursementSchemesShiftGreaterFinancialRisktoHospitalsandPhysicians

• ComparativeEffectivenessIncludesShort-TermasWellasAnnuityCosts

• UtilityandComparableValueAffectTechnologyAdoption

Service ExamplesEconomic Outcome Studies

White Paper Publications

Article Content Development

Historical Claim Analyses

Linear Cost, Claim & Payment Assessments

Data Analysis & Decision Support

Customer Cost Surveys

Value Messaging

Established Technology Company: MCRA consultants were en-gagedbyaleadingtechnologycompanytocreateproductspecificwhitepapers,salesaids,andvaluemessagetools.Combiningourproficiency inmanagingclinical researchandhistoricalclaims,aswellasourunderstandingofthecause-and-effectrelationshipbe-tween regulatory and reimbursement environments, our consul-tantsdevelopedaseriesofpublicationsthatclearlycommunicatedtechnologyvalue,distinguished theproduct from its competition,andimprovedpublicunderstandingastothecostbenefitsprovidedtopatientsandprescribers.

EmergingTechnologyCompany:MCRAconsultantswereengagedtoevaluateclinicaltrialprotocols, incorporatereimbursementval-ue drivers, collect economic outcome data during the study, andcreate value messaging that would support future commercial-ization of this novel technology. MCRA consultants are currentlypreparing a series of publications and messaging tools that willassist with technology sales and increase value to stakeholdersincludingclientshareholders.

Value Messaging & Health Economic Study Support Services From The Leading Industry Expert

MCRAconsultantsareexpertsinthedevelopingandpublishinghealtheconomicoutcomes,valueanalyses,andmessaging.

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M

MWashington, DC

1331 H Street, NW 12th floorWashington, DC 20005 Phone: 202.552.5800

Fax: 202.552.5798

New York, NY 505 Park Avenue, 14th floor

New York, NY 10022Phone: 212.583.0250

Fax: 212.750.2112

Hartford, CT63 East Center Street, Suite 3A

Manchester, CT 06040Phone: 212.583.0250

Fax: 212.750.2112

[email protected] www.mcra.com

Musculoskeletal Clinical Regulatory Advisers, LLC is the leading neuro-musculoskeletal /

orthopedicconsultingfirmassistingestablishedandemergingcompaniesinthedevelopment

and commercialization of their technologies. MCRA’s consultants are industry leaders who

supportClinical,Regulatory,QualityAssurance,Reimbursement,Manufacturing,Healthcare

Compliance,andIntellectualPropertyinitiatives.MCRA’sintegrationofthesekeyelements,as

wellasitsfocusedspecialization,createsunparalleledsolutionsforitsclients.

musculoskeletal clinical regulatory … · ... clinical project management; data management; ......

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