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How to Start a Site Management Organization

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How to Start a Site Management Organization

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  1. HowtoStartaSiteManagementOrganization? HowSitemanagementorganizations(SMOs)specializeinrunningclinicalresearchsites.IfyoudecidetostartanSMO,youwillworkformedicalresearchcompaniestofindasuitablefacilityforholdingclinicalresearchtrials.Yourcompany'sdutiesmayalsoincluderecruitingpatients,drawingupbudgetsfortrials,hiringinvestigatorstoconductthetesting,preparingbudgets,anddraftingandsubmittingtheclinicalstudy.TheSMOprofessionisagrowingfieldthatgenerated$3billioninannualrevenuein2011.Therefore,oneneedstoenrollinclinicalresearch courses toequipthemselvestounderstandtheworkingofclinicaltrials. AnSMOreceivesitsincomefromaclinicaltrialfeerelatedtothecompletionofaspecificpatientvisit.Thus,thebalancebetweenincomeandcostscanbeverydelicatewithfewerstudiesorlesspatientrecruitment.ThewholesuccessofanSMOissolelybasedonthefirst-handknowledgeofthepatientpopulationandwell-definedrelationshipswithinvestigatornetworks,enablingthemtodeliverandaddvaluetotheorganization.Moreimportantly,forasponsor,thisvalueisaddedtoanotherlineofthecashflowtothatofaclinicalresearchorganization. Readfederalguidelinesforconductingclinicaltrials.TheU.S.FoodandDrugAdministrationhasextensiveregulationsdetailinghowtoconductmedicalresearchandreporttheresultsofdrugtrialsandothertests.YourcompanymustknowandcomplywiththeregulationsiftheFDAistoapproveyourclients'newproductsortreatments. • Contacthospitalsandclinics--mostresearchsitesareestablishedmedicalfacilities--andaskabouttheirexperienceinconductingclinicaltrials.Talktotheirresearchersandadministratorsaboutthesortofresearchtheinstitutionhasparticipatedin,whatthepatientpopulationislike--age,ethnicity,health--andwhichclinicalinvestigatorsworkwiththem.

  2. Developadatabaseofdifferentfacilitiesthatincludestheirspecialties,patientpopulationsandtheirwillingnesstoserveasclinicalsites.MedicalcompaniesmayhavedetailedrequirementsDevelopadatabaseofdifferentfacilitiesthatincludestheirspecialties,patientpopulationsandtheirwillingnesstoserveasclinicalsites.Medicalcompaniesmayhavedetailedrequirements • --forexample,apatientpopulationthatrecentlysufferedafluepidemic--sothemorediverseyourlistofpotentialsitesis,thebetter. • Writeupapresentationshowingtheadvantagesofdoingbusinesswithyourcompany.Contactbiomedicalfirmsandclinicalresearchorganizations,offeryourservicesandmakethemawareofthefacilitiesandpatientpopulationsyouhavetoworkwith.

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