President | Altasciences
MARiE-HÉLÈNE RAiGNEAU
Powering a New Era of Clinical Research Innovation
Pen Editor’s From The
The Game-Changers of Research
Shaw
Pearl Shaw
Change comes from people who don’t give up. They see a chance
whereothersseeaproblemandkeepworking.Inclinicalresearch, these leaders help make trials better and faster for patients. You mightnotseewhattheydo,butitismakingabigdifference.
Everyday,theymakehardchoices.Theyfindbetterwaystosolveproblems, use technology to make research faster, and build teams that work well across countries. They are not just helping science move forward. Their workfocusesonthepeoplewhomattermost,thepatients.
In this edition, Champions of Change: CRO Leaders Transforming Researchin Insights Care,wecelebratetheseleaders.Youwillreadabout peoplewhoaresolvingproblemsandleadingchangeintheindustry Some oftheirideasmaysurpriseyou,somemayinspireyou,andallofthemshow whatcanhappenwhenpeopleworkhardandstaycreative.
As you read this edition, we hope you feel some of the energy and drive these leaders bring every day.Theirstories show that real progress comes from people who think differently, take risks, and keep going no matter what.Thisismorethanalookatclinicalresearch.It’sapeekathowtheright leadership, a bit of vision, and plenty of hard work can change an entire industry
Hopeyouhaveaninterestingreadahead!
Pearl
The Front Page Exclusive
06
18
Marie-Hélène Raigneau
Powering a New Era of Clinical Research Innovation
The Pro Perspective Industry Insights
AI at the Helm How CROs Are Harnessing Technology to Transform Research
Improving Patient Care with an Ecosystem of AI Tools
Putting Patients First CRO Leaders Championing Human-Centered Trials
14
22
Credits
President | Altasciences
MARiE-HÉLÈNE RAiGNEAU
Powering a New Era of Clinical Research Innovation
.insightscaremagazine.com
CHAMPIONS OF CHANGE: CRO LEADERS TRANSFORMING RESEARCH
Brief Featuring Person Organiza on
Bram Goorden CEO
Kelly Sager Vice President & Franchise Head, Infec ous Disease and Acute Care
Marie-Hélène Raigneau President Oliver Rinner CEO
Ixico ixico.com
Danaher’s Diagnos cs danaher.com
Altasciences altasciences.com
Biognosys AG biognosys.com
Rob Stachlewitz CEO
Resolian resolian.com
Bram is a visionary leader driving innova ve healthcare solu ons, with a focus on advancing medical imaging and diagnos cs through strategic partnerships and cu ng-edge technology
Kelly is a strategic leader in infec ous disease and acute care, championing diagnos c innova ons to improve pa ent outcomes and address global healthcare challenges effec vely.
Marie-Hélène, with over 25 years in pharmaceu cal research, excels in drug development. Transi oning from sales to leadership, she drives innova on in preclinical and clinical research.
Oliver is a pioneering innovator in proteomics, leading transforma ve research and development to unlock biological insights through advanced mass spectrometry and data analy cs.
Rob is a dynamic execu ve spearheading bioanaly cal advancements, fostering scien fic excellence, and delivering high-quality solu ons to accelerate pharmaceu cal research and development globally
The Front Page Exclusive
MARiE-HÉLÈNE RAiGNEAU
Powering a New Era of Early-Phase Drug Development
President Altasciences
Marie-HélèneRaigneauhasbuiltanimpressive careerinthepharmaceuticalresearchfield, spanningover25yearsinthedrugdevelopment industry.Herprofessionaljourneyincludesexperiencein bothpreclinicalandclinicalresearchorganizations,with morethan15ofthoseyearsspentinleadershiproles.She beganhercareerinsalesandmarketingbeforetransitioning intooperationalroles,whereshefoundherstride.
In2012,Marie-Hélènejoined asExecutive Altasciences DirectorofBusinessDevelopmentandMarketing.Atthat time,theorganizationwasundergoingastrategic transformation—fromacontractresearchorganization (CRO)focusedprimarilyonclinicalresearchand bioanalysisforgenericdrugstoafull-serviceCRO,offering comprehensive,early-phasedrugdevelopmentsolutions, fromdiscoverythroughtoclinicalproofofconceptand beyond.
AltascienceshasreceivedseveralCROLeadershipAwards, includingrecognitionasaChampionintheCapabilities categoryfor2024,basedonclientfeedbackfromISR's annualbenchmarkingsurvey Additionally,thecompany wasawardedthe2025CDMOLeadershipAwardforSmall MoleculeDosageForminNorthAmerica.
Marie-Hélène’sleadershiptrajectorywithinAltasciences continuedsteadily.In2015,shebecameGeneralManager ofthecompany’sCanadianfacilities.Threeyearslater,in 2018,shewasappointedVicePresidentofResearch SupportServices.Herresponsibilitiesgrewfurtherwhen shetookontheroleofCo-ChiefOperatingOfficerin2020. InAprilofthisyear,shereachedanewmilestoneinher careerbysteppingintotheroleofPresident.
HerdecisiontojoinAltasciencesstemmedfromastrong beliefintheorganization’spotentialtotransformand
“Be sure to focus on and listen to what the client needs. I’ve often seen companies get so wrapped up in their own vision of success that they neglect to listen to their customers.”
acceleratedrugdevelopmentbyfocusingoncustomer experienceandintegratingawiderangeofservices. Collaboratingwithtrustedcolleagueswhosharedher valuesandbusinessphilosophy,shefoundaplacewhere shecouldmakeameaningfulimpact.
Let’s delve into the interview details below!
Whatareyourprimaryresponsibilities?
OverthepastfiveyearsasCo-ChiefOperatingOfficer, alongsideSteveMason,IwasresponsibleforAltasciences’ clinical,bioanalytical,formulation,developmentand manufacturingcapabilities,andthecomplementaryCRO services,includingdatamanagement,biostatistics,project management,andmedicalwriting.Inmynewpositionas President,IsharedualresponsibilitywithourCEOChris Perkinfortheexecutiveteam,wheremyfocusisprimarily onourgrowth,strategicplanning,andoperationaldelivery
Pharmaceuticalresearchisundergoingsignificant transformation.Whatchangesdoyoubelievearemost criticalforCROstoembraceinordertostayatthe forefrontoftheindustry?
Altasciencesisbuiltonflexibilityandresponsiveness— qualitiesthataremorecriticalthaneverintoday’sevolving pharmaceuticalresearchlandscape.Astheneedsof sponsorsgrowmorecomplex,CROsmustbeabletoadapt quicklyandscaleaccordingly Whethersupportingasingle drugcandidateoranentirepipeline,Altasciencesis committedtomeetingeachclientwheretheyare,offering early-phasesolutionsthatcanexpandseamlesslyintolater stages.
WearetheonlyCRO/CDMOabletoguideasponsor's moleculefromdiscoveryallthewaytoclinicalproofof conceptandbeyond.OurintegratedCRO/CDMOmodel eliminatestheneedfordataorprojecttransfersforour clients,enablingfastertimelinesandsmoothertransitions. Andwithadedicatedprogrammanageratthehelm,our clientsbenefitfromadaptablesupport,real-time communication,andacustomizedapproachdesignedto keeptheirprogramsontrackandonbudget.
HowdoyouapproachleadingAltasciencesthrough periodsofchange,andwhatleadershipqualitiesdoyou thinkareessentialduringthesetimes?
Leadingthroughchangerequiressignificantadaptability while stayingfocusedonourmission:helpingclients
delivermedicinestopatientsmorequickly.Changecanbe challenging,butitalsopresentsexcitingopportunitiesto innovateandimprovehowweworktogetheracross functions.
Duringthesetimes,Ifocusonopenandtransparent communicationtoensureeveryoneunderstandsthe“why” behindthechangeandfeelssupportedthroughoutthe process.Listeningcloselytoourteamsandclientsallowsus toaddressconcernsandharnessdiverseperspectives, strengtheningourcollectiveresilience.
Essentialleadershipqualitiesinthesemomentsinclude empathy,flexibility,anddecisiveness.Theseareimportant toconnectwithstaffonahuman-to-humanlevel,topivot whenneeded,andtomoveforwardwithconfidence. Ultimately,leadingwithpurposeandfostering collaborationenablesustonavigatechangesuccessfully.
Technologyisreshapingthewayresearchisconducted. HowhasAltasciencesleveragednewtechnologiesor innovativemethodologiestoenhancetheresearch process?
AtAltasciences,weviewtechnologyasavaluablepartner inadvancingdrugdevelopment.Forexample,thegrowthof artificialintelligencehasopenednewpossibilitiesin pharmaceuticalresearch,andwe’vewelcomeditsrolein makingusworksmarter—forourclientsandultimatelyfor thepatientswhorelyonthetreatmentswehelpdevelop.AI allowsustosiftthroughvastamountsofdata,uncover patterns,andmakemoreinformed,timelychoicesabout whichdrugcandidatestomoveforward,andhowtobest supportthemduringearly-phasedevelopment.
WehavealreadystartedintegratingprovenAItoolsintoour processesandcontinuetoexplorenewtechnologiesthat willenhanceworkflows.Fromintuitivedashboardsthat simplifydatareviewtomachinelearningsystemsthat optimizetaskallocation,theseinnovationssupportusin managingthegrowingcomplexityofearly-phasetrials.
WhatstrategiesdoyouusetoensureAltasciences maintainshighoperationalstandardsandcontinues deliveringvaluetoclientsinacompetitiveindustry?
Itstartswithastrongfoundationincommunication.We havebuiltaculturewhereclientfeedbackisnotjust welcome,it’sintegraltoimprovingourprocessesand servicedelivery.Ourdedicatedclientexperienceteam activelygathersandtracksfeedbackthroughmultiple
“Leading through change requires signicant adaptability while staying focused on our mission: helping clients deliver medicines to patients more quickly.”
channels,ensuringclients’voicesareheardandactedupon promptly
Thisongoingdialogueallowsustoidentifyopportunities forinnovationandrefineourintegratedapproach,which bringstogetherpreclinical,clinical,bioanalytical,and manufacturingservicesunderasingleorganization—as wellasthefullarrayofCROservices.Byunderstanding ourclients’uniqueneedsandchallenges,wecan proactivelymanagetimelines,anticipatepotentialissues, andtailorsolutionsthatacceleratedrugdevelopment withoutcompromisingquality.
Wealsoinvestheavilyinstate-of-the-artfacilitiesand maintainrigorousqualitysystems,tomeetandexceed regulatorystandardsglobally.Ourbroadrangeofservices arealldesignedtoworktogethertoreducetimelinesand costsforourclients.
Inacompetitiveindustry,ourcombinationofintegrated operations,qualitycommitment,andclientpartnershipis whatsetsAltasciencesapartandenablesustoconsistently delivervalue.
Asaleaderinpharmaceuticalresearch,you’velikely facedsignificantchallenges.What’sbeenoneofthemost difficultobstaclesyou’veencountered,andhowdidyou overcomeit?
Changingthewaydrugdevelopmenthasalwaysbeendone andmakingearly-phaseresearchsimplerforsponsors aroundtheworldwasnosmalltask.It’swhatourCEOset outtodowhenhejoinedthecompanyin2010,knowing fullwellwhenhewasinanindustrythathastraditionally beenslowtoevolve.Butit’sexactlywhyIjoined Altasciences.
Theusualwayofoutsourcing,withdifferentpartners handlingseparatephases,wasoftenacausefordelays, inefficiencies,andgapsincommunicationfor sponsors—andwesetouttobridgethegapbetweenthe preclinicalandclinicalphases.
Ittookpatienceandpersistence,butbystayingfocusedon ourgoaltogetmedicinestopatientsfaster,andbyshowing thefullimpactofanintegratedmodel,webuilttrustand shiftedhowtheindustryseesCROsandCDMOs.
Thisjourneyhastaughtmethatrealchangetakestime,and leadershipisaboutguidingpeoplethroughuncertainty,with clearcommunicationandasharedpurpose.
Howdoyoucultivateacultureofexcellenceand innovationatAltasciences,andwhatkeyqualitiesdo youlookforwhenbuildingyourteam?
AtAltasciences,cultivatingacultureofexcellenceand innovationmeanslivingourcorevalueseveryday:quality, integrity,respect,customerfocus,andemployee development.Wecreateanenvironmentthatencourages, empowers,andinspiresourstafftosharetheirbestideas. Innovationthriveswhenteamscollaborateopenlyandare encouragedtochallengethestatusquo.
Excellenceisachievedbycombininghighstandardswitha culturethatactivelyencouragesparticipationand recognizesthevalueofeachidea.Thisway,wecelebrate oursuccesstogether,andviewchallengesasopportunities tobecomestronger,tobetterserveourclients,and acceleratedrugdevelopment.
Whenbuildingmyteam,Ilookforpeoplewhoarenotonly technicallyskilledandcuriousbutalsoadaptable, collaborative,anddeeplycommittedtoourmission. Integrityandastrongworkethicareessential,asisa genuinepassionformakingadifference.
Ultimately,it’saboutbringingtogethertalentedindividuals whoshareasenseofpurpose,andsupporteachotherto disruptthenormandpushboundaries.
Whatadvicewouldyouoffertoindividualswhoaspire toleadershippositionswithintheCROindustry?What skillsandexperiencesdoyouconsidermostimportant forsuccess?
Cultivateastrongteamthatispassionateaboutyour mission.Giventhecomplexityoftheindustry,it’sessential tohaveadiverserangeofexpertisetothrive.Ihavegreatly benefitedfromcollaboratingwithindividualsat Altascienceswhosecontributionshavebeeninvaluableto ourprogress.Remember,thestrengthofyourteamisakey factorindrivingyoursuccess,soinvestthetimeinbuilding andnurturingtheserelationships.
Andonemorething:besuretofocusonandlistentowhat theclientneeds.Itseemssoobvious,andyetI’veoften seencompaniesgetsowrappedupintheirownvisionof successthattheyneglecttolistentotheircustomersand adapttheirvisionaccordingly.Ourbusinessmodelhasbeen shapedbylisteningtotheirfeedback,addressingtheirpain pointswitheffectivesolutions,andcontinuallyevolvingto providethemwiththebestpossibleexperience.
Finally,wheredoyouseeAltasciencesandthebroader researchindustryinthenextfivetotenyears,andwhat roledoyouhopetoplayinshapingthatfuture?
Thebiggestchallengedrugdevelopersfacetodayis bringingnewmedicinestomarketasquicklyaspossible andmoreeffectively,navigatingcomplexregulatory requirementswhilemanagingtighttimelinesandbudgets. AtAltasciences,weunderstandthispressure,andour approachisdesignedtobethesolutionthathelpssponsors overcomethesehurdles.
“Cultivating a culture of excellence and innovation starts with living our core values every day: quality, integrity, respect, customer focus, and employee development.”
Ourgoalistocontinuetobethepartnerthatdelivershighqualitysciencewhilesafelyacceleratingthesponsors’drug developmentjourneyfromdiscoverytoclinicalproofof concept,andbeyond.
www.insightscaremagazine.com
HOW CROs ARE HARNESSING TECHNOLOGY TO TRANSFORM RESEARCH
With the rapidly changing drug discovery and clinicalresearchenvironmentofthemodernera, Contract Research Organizations (CROs) today arethefoundationofinnovation.Theyprovidetheexpertise, the capability, and the scope that the pharmaceutical and biotechnology companies need to deliver new therapies to patients.Butoverthepastfewyears,thereisoneforcethathas begun reshaping the operations of CROs above all else: artificialintelligence(AI).
AIisnolongerabuzzwordbutaforcemultiplierthattheCRO leaders are using to drive trials faster, improve data quality, and decrease the cost. By puttingAI center stage, CROs are turning research into a faster, smarter, and more patientcentricprocess.
FromDataOverloadtoDataIntelligence
Clinical trials create enormous amounts of data. Every trial has patient information, lab tests, imaging, electronic health data,andreal-worlddata.Before,months,ifnotyears,were spent handling the data manually. Mistakes could not be avoided,andfindingswereprobablygoingtoendupinpiles ofspreadsheets.
AIismakingthatrealityover Machinelearningcodecansift through vast quantities of data in seconds, recognize faint patterns,andyieldinsightsthateludehumans.ForCROs,that meanstrialoutcomepredictions,identifyingrisksearlier,and designingbetter-studiedstudies.Insteadofbeingdrownedin data, researchers are now surfing the information wave to fasterandbetterconclusions.
SmarterTrialDesign
Perhaps the most time-consuming aspect of research is actuallydesigningthetrialitself.Whoshouldbeenrolledas patients?Whatshouldbemeasuredasendpoints?Howlong should the trial be? In the past, these were all made on the basisofhistoricalintuitionandbestguess.
AI tools presently support CROs in simulating different scenarios before enrolling the first patient. AI, based on studying past trials and available patient information, can suggest the top-performing trial designs, eliminate superfluous steps, and even prescribe recruitment time. Not onlydoesthisresultinsavingsoftime,butitalsooptimizes thechancesoftrialsuccess.
AcceleratingPatientRecruitment
Patient enrollment has always been the greatest hurdle to clinicalresearch.Mosttrialsnevergetfinishedoraresetback because they simply can’t enroll enough individuals with specificcharacteristics.AIisnowbreakingthatstraitjacket.
By filtering electronic health records, social media, and patient registries,AI can choose likely participants who are bothtimelytomeetingreaterefficiency.AIcanevenpredict which patients would have the most participation during the study This allows CROs to build stronger, more diverse patient groups and reduce the dropout rate that so too often plaguestrials.
ImprovingMonitoringandAdherence
CROs are also usingAI to track trials remotely in real time. Earlier, tracking was done by site visits, paper reports, and delayedreportingofdefects.UsingAI-basedplatformsnow, anomalies get alerted in real time—whether a data entry mistake,safetyproblem,orapatient’smisseddose.
This kind of continuous monitoring not only improves compliance but also ensures patient safety. With AI monitoringfortrials,scientistsrespondfaster,regulatorsfeel more at ease, and sponsors do not lose valuable time and money
PersonalizingthePatientExperience
Perhaps the most exciting transformation is how AI allows CROstomakeclinicaltrialspatient-focused.Participantsno longerhavetobetreatedasvariableswithinadataset,AIhelps researcherslearnpeople’spersonalneedsandbehaviors.
Wearable technology, for example, can record real-time patient data and feed it into AI systems that can alter trial procedures in real-time. Chatbots can educate and motivate patients. Predictive analytics can identify which patients wouldstruggletokeeppaceandofferpersonalizedassistance.
Theresultisaresearchprocessthat’slessofalabexperiment and more of a human endeavor—something that ultimately helpsbothpatientsandscience.
ChallengesAhead
Thereare,naturally,risksinincreasedAIapplicationinCRO work.Concernsregardingdataprivacyareone,withsensitive medicalinformationhavingtobeprotectedatallturns.There isalsoariskofalgorithmicreliance,whichwillabsorbbiases unlesstheyaredesignedwithcare.AndwhileAIwillspeedup things, regulatory measures must keep up so that such new technologyfallsunderhighsafetyandreliabilitylevels.
Visionary CRO leaders are meeting these challenges Through close collaboration with regulators, embracing transparency,andblendingAIwithhumanjudgment,theyare achieving technology-assisted research without compromisingonthehumanjudgmentsciencerequires.
TheFutureofCROswithAI
ThejobofCROshasalwaysbeentobringnewtreatmentsto patientsfasterandbetter AndwiththeAIrulenow,thisjobis being hastened. Trials are shortening, becoming more accurate and more representative of the patient population. Patients are being treated as research partners, not study subjects.Anddrugsarereachingthemarketatrecordspeeds.
CRO leaders who are embracing AI aren’t simply implementing a new tool—they’re creating the future of healthcare. By using technology to reimagine research, they aredemonstratingthatempathyandinnovationcancoexist.
Withtheworldofclinicalresearchevolvingonadailybasis, onethingiscertain:AIisnolongerridingshotgun—nowit’s driving.And with CROs at the wheel, the future of research hasneverseemedbrighter
-Natalie May
e l l y S a g e r
Abo the Ahor
KELLY SAGER
is Vice President and Franchise Head, Infectious Disease and Acute Care at Danaher’s Diagnostics Platform. A computer scientist by training with extensive commercial and product development experience, she’s held senior leadership roles in healthcare technology development, strategy and marketing at Beckman Coulter Diagnostics, BD, Hospira and GE Healthcare.
The Future of Diagnostics
Artificialintelligenceisusheringinaneweraof
innovationinhealthcare.Withgrowingdemands onprovidersandsoaringvolumesofclinicaldata, AI-powereddiagnosticsolutionsaredeliveringfaster answersandbetteroutcomesforpatients.Thediagnostic industryisnowbreakingthroughlongstandingbarriers, settingunprecedentedbenchmarksinefficiencyand diagnosticprecision.AsweembracethisnextwaveofAIdrivenadvancements,we’llseerapid,positive transformationthroughoutthehealthcarelandscapeand patientexperience.
Whataresomeofthemostsignificantchallengesfacing acutecareglobally,andhowcouldAIplayaroleinthe solution?
Acutecarefacilitiesfaceincreasingpressureasmore patientsrelyonthemtoaccesshealthcare.Oneofthe biggestchallengesisovercrowding–especiallyinbusy urbanhospitals,butwealsoseelongwaittimesinsome ruralareas.Insomeinstances,we’veseenpatientswait morethan20hoursjusttobeseen,whichcanleadto adverseoutcomes.AI-enabledtoolsarebeginningtobe usedtohelpreduceovercrowdingpressurebystreamlining patientflows,helpingacutecarecliniciansmakebetter decisionsabouttreatmentprioritizationandidentifying whentodeescalatethathigherlevelofcaretofreeupbed spaceinresourceconstrainedsettingsliketheICU.
Anothermajorchallengeisthemassiveamountofdata floodingthesystem,inundatingclinicianswithmore informationthantheycanconsumeandprocess.Irecently
metwithaphysicianatamajorresearchhospitalwho sharedaboutfeelinglikehe’sdrowningindataand worryingthatit’simpactinghisabilitytotreatpatients.Ina perfectworld,hewouldconductanin-depthreviewofeach patient’scharttoinformhisdiagnosticdecisions,butthere issimplynotalwaysenoughtimetofullysearchthe completepatienthistory
Forthisphysicianandmillionsofothers,weseegreat potentialinAI-enabledtoolsthatcanmanageand synthesizedatafrommultiplesources,highlightrisk factors,recognizepatternsandevencalloutsmallfactors thatcouldbemeaningfultoadiagnosis,butwouldbeeasy tomiss.
AIwillneverreplacetheinsightofaclinician,butthese toolswillhelpsavetimeandincreaseaccuracy,freeing clinicianstofocusmoreonpatientcare.
WhatopportunitiesarepresentedbyincreaseduseofAI indiagnostics?
AIisreshapingthefieldofdiagnosticsinmanyways,from enablingtherapiddiscoveryofnewbiomarkersto supportingthedevelopmentofnewpredictivemodelsthat cananticipateandidentifytheriskofdisease.
Fromearly-stageresearchthroughpatientcare,these modelsandtoolsarealreadyhavinganimpact.We’re seeingrapidadoptionoftaskautomationtoolslikeambient listeningandgenerativeAItoreducetheadministrative burdenonprovidersinthepreparationofclinicalnotesand patientcommunications.WealsoseegrowthinagenticAI, whichholdspromiseinhelpingclinicianseasilyand quicklysearchapatient’shistoryforhypertension,for example,ortofindoutifandwhenapatienthashadapast cardiacprocedurewhentheyarriveattheERwithchest pain.ThepowerofAItoalmostinstantlysearch,process, analyzeandsynthesizedatapresentsremarkable opportunitiestoinformclinicaldiagnosticdecisions.
Lookingahead,weanticipatetoday’sAI-enabledtoolswill becombinedwithmoreadvancedpredictivemodelsthat couldbringamaterialincreaseinproductivityacross healthcare.Notsofarintothefuturewewillseean ecosystemofmultipleAItoolsworkingtogether, streamliningtasks,accessingandanalyzingdata,and helpingcliniciansprovideevenbettercare.
Wherearewenotseeingenoughprogressinthe adoptionofAI-drivendiagnostictools?
ThenextfrontieristhedevelopmentofmoreFDAapprovedmultimodalAIpredictivemodelsthatwillrapidly synthesizevastamountsofdatatodriveimproved diagnosticdecision-makingandbettertherapeutic monitoring.We’vebeentalkingaboutthisforalongtime, butinnovationandadoptioncanbeslowinhealthcare.We mustfirstidentifythegapsandunmetneeds,thencurate largedatasetsandtrainthemodels,andfinallygenerate evidencetoprovethatthetoolsworkasdesignedand protectpatientsafety Aftersubmittingforregulatory reviewandgainingapproval,wethenmustconvince clinicianstoconsiderandadoptnewapproaches.The processcantakeadecadeormore.
You’reacomputerscientist–whatnewdevelopmentsor trendsinthefieldgetyouexcitedaboutthefuture?
Ibelievewe’reataturningpointwhenitcomestotheuse ofAI.It’sthrillingtobelivinginthismoment,whenthe riseofAIhasthepowertochangeeveryfacetofhowwe findandprocessinformation.Igetexcitedthinkingabout howithasthepotentialtoturbochargeeveryhumanbeing tobeabletodosomuchmorethantheycoulddobefore. It’sliketheintroductionoftheinternet–wewilltellour grandkidsstoriesaboutbeingalivewhenthefirstAIwas broadlyadopted.
Lookingahead,whatdoyouseeasthebiggest challengesandopportunitiesforcompaniesinthe diagnosticsspace?
Ourindustryhasatremendousopportunitynowtodrive significantadvancementswiththehelpofAI.Butforusto doso,weneedtohavetherighttalent,weneedaccessto datatotrainAImodels,andweneedregulatoryclarity Withsomuchchangehappeningatarapidpaceandwith guardrailsfortheindustrystillsomewhatundefined,theAI spacecanfeelliketheWildWest.ButI’mconfidentwewill findourfootingandwe’llstartseeingthesetoolsbe introducedwithincreasingfrequencyintheyearstocome, tothebenefitofcliniciansandpatientsalike.
CRO LEADERS CHAMPIONING HUMAN-CENTERED TRIALS
Clinicalresearchhaslongbeenataleofdata,protocols, andregulation.Asmuchastheyareintegralbuilding blocks,however,thetruepurposeofresearchislost in the process—the patients. Without volunteer time-givers and trustful volunteers, there can never be a new drug or treatment developed Contract Research Organizations (CROs)todayarerisingtothechallengetoturnthisparadigm around They’re driving the movement towards humancentered trials, in which patients aren’t merely trial participants,butalsodiscoverypartners.
WhyPatientsMatterinResearch
All the medical advances we enjoy today—vaccines, cancer treatment—once were part of a clinical trial. Behind the
statistics and numbers were actual people who suffered the weightofsicknessanddecidedtovolunteerforthechanceata bettertomorrow
But in the past, conventional trials have had their priorities wrong: protocol first, people second Participants are generally requested to travel far to trial sites, memorize complex instructions, or wade through piles of paper. It has typically meant frustration, high dropout, and trials too meagerindiversity
Observing this, CRO leaders are transforming trials. Their goalissimple:patientsfirst.
RedesigningTrialsAroundPeople
Human-firsttrialsstartwithcompassion.CROexecutivesare asking: What must patients have in order to feel cared for? Howdowemaketrialsmoreaccessibletojoinandfinish?
Thesolutionsaremorelikelytoinvolveadaptivetrialdesign thatcanbeintegratedintodailylife.Decentralizedorhybrid trials, for example, allow patients to be part of the trials remotely at home using digital equipment and wearables. Insteadofgoinglongdistancestoahospitalorclinic,patients can offer their health data remotely, liberating them from energyandtimeexpenditure.
By building trials around people rather than rigid protocols, CROs are making research more democratic and engaging morepeople.
ListeningtothePatientVoice
Another astounding shift is patient participation in trial design. CROs are working with patient groups and communityorganizationstounderstandwhatmattersmostto participants.
For example, patients can be reported to say that multiple blood draws are exhausting, or side effect reporting is confusing By listening and reacting, CROs can design studies not just scientifically robust but also participantsensitive.
Thisfeedbackloopbuildstrustbackup,andtrustisessential toanytrialtobesuccessful.Ifpeoplecanhearthem,patients are more likely to remain engaged and encourage others to takepartinresearch.
TechnologywithaHumanTouch
Technology is also contributing a lot to make trials more patient-friendly Smart apps now allow the participants to track their progress, remind them, and see educational content Telemedicine consultations allow patients to communicate with physicians while sitting in their residences.
But technology is not convenience. Technology is empowerment.Patientscanviewtheirowndata,viewwhere theyfitwithinthestudy,andfeelmoreapartofthebigplan. CROleadersensurethattechnologyisneverusedtoeliminate humantouch—it’susedtoenhanceit.
DiversityandInclusioninTrials
Maybethebiggestdangertoclinicalresearchhasbeenlimited diversity Earliertrialshavebeenfilledwithcertaingroupsof
individuals,andthathascreatedknowledgeholesabouthow treatmentsworkwithvariouspopulations.
CROleadersarerespondingtothischallengethroughactive outreach to under-resourced populations. They’re simplifying enrollment processes, offering translation services, and establishing alliances with local healthcare providers.Intheprocess,they’redevelopingtrialsthatmore accurately reflect the real world, leading ultimately to safer andmoreeffectivedrugsforeveryone.
SupportingPatientsBeyondtheTrial
Human-oriented trials go even outside the clinical setting. CROsarenowfocusingonemotionalandlogisticsupportas well.Thatis,providingsupportintransportation,conducting psychological support, and being transparent with communicationatalltimes.
SomeCROsareevenemployingpatientnavigators—professionals who guide participants through the trial, answer questions, and act as a go-between for scientists and patients. These smalltweaksmakeagiganticdifferenceinthetrialexperience asawhole.
TheRoadAhead
Converting to patient-led research is not simple. It means spendingmoney,hiringextrastafftraining,anddoingthings differently. But the benefits are absolutely worth the cost. Trials are shorter, dropout is lower, and what is collected is richerandmorereliable.
First and foremost, this strategy places the human element frontandcenteroncemorewithinscience.CROleadersatthe helm of human-led trials are showing that ingenuity and compassionwalktogether.
AFutureBuiltonPartnership
Clinicaltrialsarenotsomuchaboutdrugtesting—it’sabout building trust and partnership between society and science. Byputtingthepatientatthecenter,CROsarebuildingafuture where trials are less of an interruption and more of an opportunitytodrivethecauseforward.
And when more CRO leaders come aboard to embrace this vision,clinicalresearchwillnolongerbedonetopatientsbut donewithpatients.Andthatslightshiftholdsthepotentialto changehealthcareforgenerationstocome.
-Pearl Shaw
www.insightscaremagazine.com