A Data Driven Approach to Coordinate Challenging Smallpox Vaccine Logistics
The Specific Situation
• Arandomized,double-blind,placebo-controlledPhaseIIIsmallpoxvaccineimmunogenicityandsafetystudyneededtoenroll4,000healthysubjectsacross34sitesintheUS,foratriallastinguptoninemonths.
• TheSponsorselectedChilterntoperformfullservices,includingcoordinationoftheDataMonitoringCommittee.
• Thestudydesignrequiredseparatemaskedandunmaskedpersonnelandstudyproceduresandanatypicalresourcingstrategygiventheunevenenrollmentrates.
HowcouldthesponsorensureappropriateCRAresourcelevelstohandlecomplex,ongoingsubjectmonitoringrequirements?
THE KEY QUESTION:
Key Words: Anti-Infectives/Vaccines, Smallpox, Healthy Volunteers, Unmasked Monitoring, Collaborative Technologies
Designed Around You
North&LatinAmerica:+14239689533AsiaPacific&Europe:+44(0)1753512000
www.chiltern.com
A Customized Solution
• DeployacustomizedCollaborativeTechnologiessolutiontofacilitatestrictmaskedandunmaskeddatacontrolbasedonproject-specificrolesandresponsibilities.ThisincludedadaptingtheChilternSAFEeTMFforunblindedandblindeddocumentmanagement,settinguptheendpointIRTformedicationdistributionandnotificationsandestablishingsecureareasforcoordinatingandcommunicatingdirectlywiththeDataMonitoringCommittee(DMC).
• UsecustomizedEDCreportingtocalculatereal-timesourcedocumentverificationstatus.Compareactualmonitoringtimerequiredfrompriorvisitstoforecastoptimaltiminganddurationofsubsequentvisitsbasedondataavailabletomonitor.
• RampupanddownCRAresourcingatexactlytherighttimesbasedonpredictedmonitoring.Addco-monitorstosupplementeffortsathighvolumesitesandformaintainingmasked/unmaskedtasks.
• Developanddeliversite-specificrecruitmentplanspriortositeinitiationtoensureinvestigatorsandcoordinatorsbuy-intorecruitmentobjectives.Sendmonthlyenrollmentstatusnotificationstogeneratecompetitionamongsitesandholdsitesaccountablefortheirperformance.
The Positive OutcomesFocusingfromtheoutsetontheresourcesnecessaryforsuccessfulenrollmentandmonitoringledtocreationofaflexibleandextremelyeffectivestaffingmodel.Similarly,understandingthetechnologicalimplicationsofcombiningblindedandunblindedactivitiesenabledChilterntoimplementadatainfrastructurethatwasbothsecureandaccessible.
• Enrollmentwascompleted2monthsaheadofschedule.
• Proactiveprocessdevelopmentandsiteoutreachboostedsiteengagement.
• AccurateforecastingofthenumberandlengthofmonitoringvisitsallowedCRAresourcestobeadjustedinreal-timethroughoutthetrial.
• Chilternhasbeenselectedfor2subsequentprojects,andtheSponsorcontinuestoapproachChilternforrepeatbusiness.
Key Words: Anti-Infectives/Vaccines, Smallpox, Healthy Volunteers, Unmasked Monitoring, Collaborative Technologies
32212
