Industry Sagacity
The Impact of Emerging Technologies on The Pre-Clinical CRO Market
Redefining Advancements
Role of CROs in Shaping the Future of Clinical Research
Most
Dr Ibrahim Farr Chairman and CEO Pivotal
DuringtheCOVID-19pandemic,ifclinicians,
healthcareservice-providingstaff,nurses,and doctorswerebattlingattheforefront,thenthe ClinicalResearchOrganizations(CROs)havebeen workinghardinthebackgroundtodevelopeffective vaccinestofightthisnovelcoronavirus.
Withmillionsofcasesemergingeverydayglobally,the demandforquickvaccinationraisedtheexpectationsfrom theCROstorisetotheoccasionandintensifytheirvaccine research,clinicaltrials,testinganddevelopmentalefforts, whichtheydidinarecordtime.
Becauseoftheirtremendousefforts,weasaglobalunit cameupwithnearlyadozenvaccinesalreadybeing deployedworldwide,withoversixty-eightpercentglobal populationvaccinatedatleastonce.
ThesearetremendousachievementswhiletheseCROsare furtheradvancingtheirforcestofindmorepossibleways throughnoveltechnologiestomitigatethevirusspreading andboosttheglobalpopulation’simmunityfurther
Themomentumwillbecarriedforwardaspredictedbythe Reportlinker’sreport.Accordingtothereport,theglobal CROmarketisprojectedtogrowataCAGRof10.06% during2022-26andreach$40billionbytheendof2026. Thereportfurtherstatesthatthemarketwillbefurther drivenbythegrowingbiopharmaceuticalindustry, increasedglobalR&Dexpenditureandinvestment, regulationsofclinicaltrials,andtechnologicalinnovations inthehealthcareindustry,particularlyintheCROend-user marketsegmentandgeographicallandscape.
Tograsptheseverypositivescenariosforthepresentand futureoftheCROindustry,InsightsCare’steamunveiled thisexclusiveeditionofthe‘10 Most Innovative CROs To Watch In 2023.’ThesetenCROsareamongthedisruptive innovatorswhenitcomestoclinicaltrials,R&D,and assistingthevaccinedevelopmentdrive.Alsoincludedin thiseditionaretwotrendyarticlesourin-houseeditorial teamcuratedtogiveyouaholisticviewoftheentire scenario.
FlipthroughthefollowingpagesandwitnessCROs’ futuristicleapintoahealthiertomorrow;enjoy!
-Anish Miller
1MED SA 1med.ch
Biomapas biomapas.com
CLINERGY Health Research clinergyhealth.com
Ino v ino vco.com
Link Medical Research linkmedical.eu
Enrico Perfler CEO
1MED is a Swiss-based regulatory and quality consultancy company and full service CRO
Audrius Sveikata CEO Biomapas is a func onal and full outsourcing solu on provider to the global life science industry
CLINERGY was created to fill gaps le by the tradi onal outsourcing model and to leverage opportuni es for the healthcare industry and clinical sites on a cost-effec ve way, so that health innova on reaches pa ents faster
Bob Leasure CEO
Through scien fic leadership and ongoing investments, Ino v delivers a comprehensive range of nonclinical and analy cal services that will exceed your expecta ons.
Ola
CEO
LINK Medical is a full-service Nordic CRO providing product development services for the pharmaceu cal and medical device industries across Northern Europe.
NDA Regulatory Science (NDA Group) ndareg.com
Chris ne Lind Vice President Commercial
NDA is a leading regulatory drug & device development consultancy, suppor ng companies with their regulatory, pharmacovigilance, quality and strategic planning.
OnQ Research onqsa.co.za
Catherine Lund Founder and Managing Director
OnQ Research is a South African contract research organisa on that offers services to assist with the en re con nuum of clinical research.
Orphan Reach orphan-reach.com
P.R.I.S.M.A.- CRO GmbH prisma-cro.com
PIVOTAL pivotalcr.com
Thomas
CEO Orphan Reach is a full-service CRO with clinical opera ons in place since 2002.
Gernot
P.R.I.S.M.A. is a German Clinical Research Organiza on (CRO) and dedicated to support the European por on of the pharmaceu cal and biotech industries’ clinical development programs.
Pivotal is a Contract Research Organiza on that weaves together the scien fic insight, the technology and the resources to help customers address both current and future needs.
Tiago M D da Silva Managing Director Gudmundsen Ogorka Cremer MD Dr Ibrahim Farr Chairman and CEO
Pivotal’s team is proud of being involved in the ac va on, conduc on and the execu on of discrete full ac vi es of nearly 500 different clinical research projects in quite dis nct therapeu c areas and phases and with many diverse inves ga onal compounds, devices and products.
Dr Ibrahim Farr Chairman and CEO
Pivotal
Pharmaceuticalcompanieshavebeenincreasingly
usingoutsourcingtobemoreefficientandeffective indrugdevelopment,helpreducetime-to-market andboosttheongoingcommercialsuccessoftheir products.ThisshiftisacceleratingM&Aacrossmany segmentsofoutsourcedpharmaceuticalservices.Acrossthe pharmaceuticalvaluechain,outsourcedservicesaregaining traction,fromdrugdiscovery,contractresearchandcontract manufacturingtocommercializationservices,safetyand riskmanagementandpharmaceuticalIT.
CROsgenerallyemployanexpertise-driven,project-based consultingmodelthatrequiresstrategyandcapability aroundmanagingcomplextrials.Mostimportantly,while somelargeserviceprovidersexistinthissegment, significantconsolidationopportunitiesexist.Incomparison, thepreclinicalCROmarketismorematureand consolidated.Overtheyears,manylargepharmaceutical manufacturershavemovedfromworkingwithasetof preferredproviderstoformingstrategicpartnershipswith onlyoneortwolargeCROs.
Nevertheless,otherpharmaand,preferably biotechnological,companiesdostillprefertoworkwitha setofqualifiedmid-sizeCROsinordertoprovidethem withmorepersonalizedfocusedspecializedservices.
Withtheobjectiveofbecomingareliablefull-serviceCRO, Pivotalwasbornbackin2001ontheprinciplethat strategicscientificandmedicaladviceandsupportshould bethebackboneofallclinicaltrialswithproperand sufficientresourcestocovernotonlytheexecutionofall essentialaspectsandstagesofclinicaltrialsfromsetupto executiontotermination,includingclinicalmonitoringand projectmanagement.
UndertheleadershipofDrIbrahimFarr,Chairmanand CEO,Pivotalalsooverseesothercomplementaryactivities suchasmedicalmonitoringandwritingsupport,or pharmacovigilanceanddata-managementandbiostatistical services,i.e.,almostallthatittakestocompleteaclinical trial,whilejustleavingsomeveryspecializedtasks(e.g., drugdepotservicesorlab.analytics)inthehandsofvery specializedvendorsindependentfromthecompany.
Now,almost21yearsfromitsfoundation,Pivotal’steamis proudofbeinginvolvedintheactivation,conduction,and theexecutionofdiscretefullactivitiesofnearly500 differentclinicalresearchprojectsinquitedistinct therapeuticareasandphasesandwithmanydiverse investigationalcompounds,devicesandproducts.
Withsomemoredetail,Pivotalhasbeenengaged,upto date,inatotalof361clinicaltrials–fromphase1tophase 4-thatinvolvedthemanagementofalmost6,000 investigationalsitesand>40,000patientsandincloseto 115non-interventionalstudies(NIS)whichinvolved,in turn,thehandlingof>9,000sitesand>62,000patients.Or in“bignumbers”:anaccumulatedexperienceresulting fromworkingwith>15,000sitesand>100,000patients–a heavybackpacktosupportitsexpertiseandknowledge.
Pivotal’steamgenuinelybelievethisallhasonlybeen possiblebecauseoftheirprovenexperienceinanddeep knowledgeoftheclinicalresearchlandscapeandbecauseof thehighqualitywithwhichPivotal´sassociatesfaceand manageallclinicalprojectsthathavebeenentrustedwith–alloftheseaspectsatrademarkofPivotalandwhichhave warrantedanessentialnumberofclientsrepeatingbusiness withus(almost75%ofrepeatbusiness),andothersturning toPivotaltoassumetherescueoftheiron-goingtrialswhen “notflowing”asplanned(some32clinicaltrialstodate).
Yet,andasidefromallthosemoregeneralandtechnical featuresdefiningPivotal,theteambelievesthatitsmost essentialstrengthscomenotonlyfromthemselvesbutalso
,Pivotal’s team genuinely believe this all has only been possible because of their proven experience in and deep knowledge of the clinical research landscape.
fromitsinternalcultureandauniquewayofapproaching theirclientsandtheirconcerns, always from a personal perspective and commitment to deliver high-quality results.
Overtheyears,Pivotalhassucceededinattracting–and retaining-exceptionalassociates,allcommittedtoand passionateaboutclinicalresearchanddeliveringmedical solutionsmuchclosertopatients.Such“exceptionality”can befoundatalloperationallevels,anditsstaff–particularly itsseniormanagementteams-isabsolutelyapproachable anddirectly–andpersonally-involvedinallprojectsthatthe companycollaborateswith.
Pivotalanditsassociatesareprettyawareofhowcostlyand crucialeverysingleprojectmightbefortheclients.They feelunabletogetintoanyclinicalstudy–ampleor “tiny”-withoutputtingthecompany’sexperienceand knowledgeintothem.
WhenworkingwithPivotal,clientsdonotsimplywork with“individuals”butwitharobustteamdrivenbya“oneteam”attitude,commitment,andintegrity.Pivotaltriesto keepitscustomersinthecenterofitswork,listentotheir
inputs,andputitselfintheirshoestobettercomprehend theirneedstobecomeanextensionoftheirteams.
Last,itisimportanttomentionthatapartwithitsclients, Pivotalaimstostayconnectedwiththe“ecosystem”–namely,thewholeclinicalandinnovationcommunities-to warrantin-timeaccesstobreakthroughscience,bestsites, talent,andtechnology—deliveringdailytoitsclients,and makingsureeverydeliverable,document,slide,ormessage isclear,addsvalueand,eventually,reducestimetomarket. Thisalliswhat,theteambelieves,hasmadePivotala favoritepartnerforahighnumberofBiotechandPharma companies.
Itwasundoubtedlyunthinkablebackin2019thata “catastrophe”likewhattheCOVID-19pandemichas representedcouldsimplyhappenand,muchlesspredictall theeffectsitbroughtalongside–atagloballeveland, obviously,atanysmallersinglecompartmentofhuman lives,includingtheclinicalresearchecosystem.
AnalyzinghowtheCOVID-19hasimpactedtheclinical trials–andmayimpactinthefuture-isnota
straightforwardquestionbutratherapolyhedriccomplex problemrequiringsimultaneouslooksfromquitedifferent butcomplementaryangles.
Firstly,ithasaffectedallcompaniesdevelopingnew medicalsolutionsforpatients,includingBiotechand Pharmaandothersupporting-servicescompanieslike clinicalCROs.Then,undoubtedly,ithasimpactedthe organizationofinvestigatorsatinvestigationalsiteswho hadhadtoadapt,fromonedaytothenextone,toa differentwaytohandleandmanagetheirclinicalresearch activitiesandtheirpatients–withpatientsnotabletoattend theirvisitsatthesites.
Andlast,likelythemostcriticallinkofthechain,ithashad animpactonthousandsofpatientsbeingtreatedinthe contextofclinicaltrials,frightenedthatthehopestheyput ineverynewtreatmenttheywerehelpingtodevelopfor themselvesandforothersmaysimplyflyaway.However, despitethepotentiallyterriblescenariothatCOVID-19may haveresultedin,allactorsinvolvedinclinicalresearch havefoundawaytomoveforwardandovercomeall hurdlesencountered.
Indeed,theCOVID-19pandemicandalllessonslearned willconditiontheclinicaltrialsarenainthefutureandhow allactorsinvolvedplaytheirrespectiveroles.Andpotential newclinicalresearchscenariosandruleswillneedtobe considered,yetstillmaintainingpatientsattheverycore, warrantingtheirrights,hopesandillusionsandhavingthem reassuredateverymoment–mayotherpandemicburstout (oranyothersimilarevent)thatthey,patients,willbe treatedasneededanddeserved.
Amongthelessonstakenfromthe“COVID-19experience, Pivotalhaslearnedthattherearealternativestotheclassical face-to-facevisitstositesandthatdatacanstillbecollected andverifiedremotelyasmuchaspossible.Butalso,others bysimplyusingonlinetechnologiesthatallowpatientsto transmitoutcomes,asperthecorrespondingprotocol.Orin otherwords,theCOVID-19pandemichasprobablyopened upthedoortothatnewtypeofdecentralizedclinicaltrials (DCTs).Advantages,disadvantagesandchallengesofDCTs vs.centralizedtrialswillrequire,ontheotherhand,deep discussioninanotherarticleandthisisbeyondthetopics thatpretendtobenowcovered.
PivotalalsoexperiencedthatduringthisCOVID-19period, thestudytreatment–commonlyadministeredateach investigationalsite-canbeefficientlydeliveredtopatients bypostorcouriertothesafetyoftheirhomesforselfadministration.Andthatevenformorecomplex administrationroutesrequiring,forinstance,injections, specializedstaffmayvisitpatientsattheirplacesfordosing –and,whynot,tocollectsamplesasneeded.
Nevertheless,anddespitethealternativesjustpointedout andappliedbyPivotal,therewillsurelybemany procedures,trialactivitiesandmeasuresortrialcompounds –e.g.,particularlyunstable-thatwillnotallowaneasyshift tothispotentialnewmodelofmakingclinicalresearch home-friendly
Beasitmay,the“take-home”messagefromtheCOVID-19 outbreakisthatalternativewaysofdoingclinicalresearch arepossibleandthat“rethinking”clinicaltrialdesignsand operationalapproachesaremuchmorethanrecommended. Allparties–fromsponsorstoinvestigatorsandsitesto patientsandregulators-mustchangetheirmindsetsand lookatthesealternativeswithinterestsincetheymayalso helptoreducetheoverallcostsofclinicalinvestigations. AndPivotalandotherclinicalCROs,ontheirside,will havetoadapttheiroperationalprocedurestothisnew clinicalresearch(remote)environment–surely,alongway togoahead,butmuchmotivating.
,Pivotal definitely wants to play the new game of DCTs but always remains true to its clientoriented and pa ent-centric a tude, its commitment, and strong belief in science and quality as the basis to build on medical discoveries and advances.
Innovationandnewtechnologieswillbethebasisofthis potentialtransformation,whichisalreadyinPivotal’s DNA.Thus,thecompanymeetsthefirst“inclusion criterion”forthisnewenvironmentandparadigmshift.
Andforthefuture,thecompanyconsiders,ifnotentirely shiftingtoDCT-likeapproaches,atleasttostartwalking thatnewpathwayparalleltotheclassicalone.Pivotal definitelywantstoplaythenewgamebutalwaysremains truetoitsclient-orientedandpatient-centricattitude,its commitment,andstrongbeliefinscienceandqualityasthe basistobuildonmedicaldiscoveriesandadvances.
TheCROmarketisconstantlymoving,andonthebasis thereof,“M&A”processesrelyon.Andasaconsequence ofthis,newgiantactorsemergeeveryyearwhilesmaller CROssuffer,ifnotliterallyclosethebusiness.Niche specializationorshiftingtonewtargetsponsors–e.g., biotech-mayhelpthemtosurviveandthrive,though.
Thesearecertainlythemarketrulesbutareatrendthatmay deprivethesmallerinnovatorsBiotechofpartneringwith theright-sizeyetexperiencedCROsifnootheractorscan befoundoutthere.Notmuchtodotostopthemarket’s hunger,butjustsendingamessagetosmallerinnovators andsharingthethoughtthatrightsizingisstillavalid principleforsponsorstoconsiderwhenselectingtheir partnerCRO–hence,mid-sizeCROssuchasPivotalwill surelybemuchmoreagileandwillputtheirclients´ projectsamongthosemuchmoreimportantfortheclient.
Mid-sizeandsmallerfocusedCROsarelikelydifferent frommergedgiantsinthattheymaybejustonemoreteam memberoftheirclientsandworkincrediblyclosetothe properclients´internalteams.Andatleast,thisiswhatthe companyhasbeendoingandpretendingatPivotaland what has been the basis for its success story to date.
Thefuturestartstoday,actually,andfor2023Pivotal intendstokeepgrowingwhileremainingfaithfultothe “organicgrowth”policyithasbeenfollowingsince inception–ratherthanbasingitsexpansionsolelyon “M&A”operations-.Therefore,thecompanyplanstooffer somethingelsetoenticeoldandnewclients.COVID-19 outbreakhaspointedoutthenewpathwaytofollow-DCTs, digitalization,technology-and,asalreadymentioned,thisis amaneuverinwhichthecompanyhasalreadybeen investingtogetthere.Butintheshortterm,Pivotalplansto
worktowardsgivinganimpulsetothesciencebehind clinicalresearch.
Withthisobjectiveinmind,thecompanyhasonboarded newtalentforgedinaresearch-makingenvironmentwitha provencapacityforplanningandconductingexperiments and,importantly,foranalyzing,interpreting,andpublishing results.
Pivotal’sultimateideaistoprovidesuchstrategicscientific analysisandadvicetoitsclientsineverynewprojectitis awarded,inreal-time,sothatrapidbutrobustdecisionson howtoprogressforwardcanbemade,avoidingthe compromisingofatotalbudgetinaprojectthatmayhave lostsenseorwhichmaybenefitfromre-focusing.
Pivotalisproudofbeingthefoundationitistoday,andits teambelievesin“we-are-Pivotal;”henceitrunstheriskof actingsubjectivelywhengivingmarkstothecompany Externalindependentopinionsmayhelp,though.These wordsofwisdomshowcasethestatusquoof Pivotal—beingoneoftheinnovativeCROsinthe healthcareindustry.Detailedquotesaredepictedinour websiteatwww.pivotalcr.comandatourpatientjourney armdivisionatwww.pivotalpatientjourney.comandbelow isanexampleofthesequotes:
“PivotalcontinuestobemyCROofchoice.They complementourexistingteambyprovidingfunctionalarea expertisethatwedonotcurrentlypossess.Theirpersonnel arehighlyengaged,experienced,andproficientinwhat theydo.Pivotal’sleadershipteamisexperiencedandmore importantly,incrediblyengagedthroughouttheentirestudy. ThesearesomeofthereasonsPivotalcontinuestobea trustedpartnerforus.” -Chief Operating Officer, at a USbased Medical Device Co
“IhaveworkedwithPivotalontwostudiesandhavebeen particularlyimpressedwiththecaretheygivestudies,their personalattentiontotheneedsofsponsors,andtheir dedicationtogettingthingsright.Pivotalisaclosely-knit group.Thereisnobureaucracy,simplythededicationto servingtheneedsoftheirbiotechclients.Theyarethe closestthingIcanfindtohavingmycompanypersonnelon thegroundinSpainandEurope.”-ChiefMedicalOfficer,at aUS-basedBiotechCo
“TheteamatPivotaloperatesasaseamlessextensionof ourinternalteam,buildingtrustwithourEuropeanclinical trialsitesandourconfidenceinourabilitytoexecutehighqualityclinicaltrials.ThePivotalmanagementteamactsas atruepartner,equallyfocusedonourobjectivestodevelop innovativetherapeutictreatmentsforpatientswithserious unmetmedicalneeds.” -Group Vice President, Development Sciences Operations at a Mid-Size US Pharma Co
“AsanindependentinvestigatorandheadofaCooperative Group,IhavebeenworkingwithPivotalsince2014onsix projectsinGUtumorsandwhatIhaveencounteredisa dedicatedteamtoclinicalresearch,verymuchattentiveto thecomplexneedsofindependentinvestigators, responsivenessandquality-mindedthroughout.
Theteamgetsitrightthefirsttimeinalltheservices, includingregulatoryandclinicaloperations,medicaland safetymonitoring,datamanagement,andbiostats.Pivotalis myfavoriteCROstoworkwith,andIhavenohesitationin recommendingitforanynewtrialsinOncologyand beyondinEurope.”-Senior Researcher PSMAR/IMIM Hospital del Mar, Barcelona, Spain, and Associate Professor of Medicine Harvard Medical School
“IhaveworkedwithPivotaloninternationalclinicaltrials bothofanICUtherapeuticandacancerscreening device/diagnostic.Icannotthinkofabetterpartner Acosteffectivecollaboratorwithdeepfunctionalexpertise, particularlyindatamanagement,biostatistics,medical monitoring,pharmacovigilance,andprojectmanagement, butevenmoreimportantly,acompanywithacultureof problem-solvingandsharedresponsibility
WorkingwithPivotalisnever“us”and“them”;itisone sharedmissionwithagroupofprofessionalswhosimplydo whateverittakestoaccomplishthegoal.Thisstartsatthe top,withthecredible,expert,andever-presentleadershipof theCEO,himselfaformerseniorPharmadrugdeveloper, andfiltersthrougheverylayeroftheorganization.”
-CEO, at a US-based Biotech Co.
“Thepatientrecruitmentprocesshasbeenawe-inspiring, andIhavelearnedalotthroughyourcompanyandyourCLyspatientplatform.Youaremakingtheworldofresearch abetterplacewithyourcompanyandyourways.”
-Ophthalmologist and PI and Med. Monitor lead in FDAmonitored clinical trials.
“Andalloftheaboveseemstobesupportedbythefactthat Pivotalwasselectedasoneofthefewfirmsthatattracted recognitionfromthePharmaIQnetworkasaRISING STAR.”
Theresearchbasecomprisedinternationalparticipantsfrom mainlybigPharmaorBiotechs,SMEspharmaand consultants,governmentbodies,medicaldevice manufacturersandpublichospitals.Wehavekeptdoingas goodasthen,soweareconfidentwewillsurelybe perceivednowaswethenwere.Clientshavethelastword, butbusinesscominginalignswiththisfeeling.
,Pivotal has succeeded in a rac ng – and retaining- excep onal associates, all commi ed to and passionate about clinical research and delivering medical solu ons much closer to pa ents.
Technologyischangingthehealthworld’sfuture, whilefuturetechnologyisreshapingthepresent worldofhealth.Alreadyemergingfromthe turbulentoceansofchangingtimesarenovelwaysof carryingoutorperformingpreclinicalresearchand conductingtrials.
ManygiantClinicalorContractResearchOrganizations (CROs)havealreadystartedintegratingtheirpreclinical research,testing,andtrialswithnotonlydigital,virtual, andremotetechnologiesbutarealsoimplementing ArtificialIntelligence(AI),CloudComputing,and MachineLearning(ML)technologiestoefficiently conduct,perform,orcarryoutsuchexperimentsin increasinglyenhancedenvironments.
Theprocessofdevelopingamedicinalproductisalong one,wheretherearemanysubprocesseslikeideaor conceptgeneration,framing,discoveringanddeveloping thatideafurther,thenthepre-clinicalresearchstagethen comestotheclinicaltrialstage,andfinally,theFDA assessmentandreviewstagewhichapprovesor disapprovestheproductbasedonitscriteria.
Althoughallthesesubprocessesareequallyimportant,the stagewherepre-clinicalresearchisconductedisthemost crucialoneastheprospectiveproductideasorconcepts
haveastrongchanceoffailing.Thisiswherepreclinical CROsplayaverymajorroleinoptingforadvanced technologiessotheycouldresearchtillthelastelementof eachideaandconceptfromeverypossibleangle,andfind outthepossibilities,andprobabilitiesofthesuccessandthe failureofthedrugormedicineindevelopment.
Moderntechnologiesarenotonlygivingmorepowertothe preclinicalCROstolookatthepreclinicaltrialprocesswith aholisticviewincreasingtheprobabilityofthedrugor medicinemovingtothefurtherstagebutarealsohelping theminsavinghugecosts.
Letuslookindetailatthesereasonsanddigourselves deepertogainabroaderperspective.
AHolisticTechPerspective:
AdvanceTechnologicalImplementationlowersthe Uncertaintyofthepreclinicalexperimentsbystreamlining andoptimizingdetaileddatacollection,easingdownthe pre-clinicaltrials’subjectselection,decreasingthetime durationofresearch,andreducingfinancialcosts.Research, datacollection,testsubjectselectionandcontinuous analysisareanintegralpartofdrugresearchandmedicine development.However,withincreasingintricacyinthe entireprocess,navigatingthroughthecontinuousstreamof incomingdatagetsimpossibleforthehumanresearcher
Thisiswhereadvancedtechnologieslikeautomation,AI, cloudcomputing,BigDataAnalysis,ML,etc.providenot onlymonitoring,tracing,tracking,andcollectingdatabut alsodeepandmachinelearningoftherecordeddatatooffer preciseanalysis,interpretation,flow,patternwhile matchingthesampleswithearlieravailableones.
Live COVID-19 Example:
Itisbecauseofusingsuchnoveltechnologiesthatinjusta yearandahalf,CROsacrosstheworldcouldcomeupwith morethanadozencoronavirusvaccinesincludingSerum InstituteofIndia’sCOVOVAXwhichhasbeendeveloped throughthreetrialsinonecountryandapprovedinfive countries,COVISHIELD(OxfordAstraZeneca Formulation)developedthroughfourtrialsinonecountry andapprovedin49countries;Novavax’sNUVAXOVID whichhasbeendevelopedthrough17trialsin13countries andapprovedin38countries;Oxford/AstraZeneca’s VAXZEVRIAdevelopedthrough66clinicaltrialsin31 countriesandapprovedin140countries;andsoonandso forth.
Duetothisrapidvaccinedevelopment,accordingtoThe NewYorkTimes’COVIDvaccinetracker,asofJuly2022 over5.23billionpeopleor68.2%oftheworldpopulation havereceivedadoseofaCOVID-19vaccine.
Clinicaltrialresearchersalsogetbenefittedbygaining actionableinsightsintothedetailedreportscreatedbyusing digitaltechnologies.Forexample,AIandMLarenow widelyusedinthemostappropriatesamplegroupselection thatrespondsmoretothepre-clinicaltestsandtrials.
Thefirstmajoradvantageofusingthesetechsisthe automatedcellularlevelselection,datagenerationand analysis.Thesefuturistictechnologiesmoderncell-based selectionoffersanearly-stageissueidentificationand problemdetectionwithpotentialdrugdevelopmentsand testing.Itaidsinreducingsamplewastage,time,andeffort, andstreamlinestheentireprocessofresearchand development.Forexample,datasamplescollectedduring theresearchusingAIcanalsobeutilizedforthemost suitablepatientmatchingduringtheclinicaltrialstesting process.
Preclinicalimage,graphics,andsamplematchingand analysisprocessautomationarealsofeasibleusingtechs suchasAIandML.CROsarenowincreasinglyusingthese technologiesforautomatedtestingsampleanalysis, identificationofmolecularcompounds,andanalysepatterns fordrugdiscovery
ForExample,AIisnowbeingusedbytheInstituteof CancerResearchformakingpredictionsregardingcancer drugs’novelprospectsandperformingrepetitivetaskslike researchrecordup-gradationanddataextraction.Likewise, scientistshavesuccessfullydevelopedEve,anAIRobotto helpresearchersinspeedingupthedrugdiscoveryprocess.
-Anish Miller
TheHealthcareindustryusuallyfacesproblemsto
bridgethegaptosolvetheproblemspromptly,and isn'titsomethingthatshouldbetakencareof?
Acknowledgingtheseconcernsoffillinguptheoperational gapsandsolvingtheproblemsinatimelymanner, ClinergyHealthResearchhassolutionstoavarietyof managerialissueswhilealsoprovidingafullrevampofall thehealthcareprocesses.
Havingthisproblem-solvingapproachandabundant experience,TiagoMDdaSilva,ManagingDirector,has scientificandmanagementknowledgetoenhancethe operationalexperienceanddeliversuperiorresults.
Inaninterviewwith Insights Care,Mr.daSilvatalksabout Clinergyrolesandhowitismakingasignificantdifference throughitssolutionsintothehealthcareniche.
PleasebriefouraudienceaboutClinergyHealth Research,itsUSPs,andhowitispositionedasareliable nameintheCROsector?
ClinergyisaCRO,butwealwaysliketohighlightthatour "C"standsfor"Collaborative"ratherthan"Contract,"and, whileforsomepeople,thatmightlooklikeasmalldetail,it makesallthedifference.
BeingaCollaborativeResearchOrganizationmeansthat ourstructure,processes,values,andpeoplearefully focusedonlong-termvalue-addingpartnershipsratherthan onshort-termtransactionalrelationshipswithclients. Suchamindsetallowsustotrulyembraceourclients´ visionandwaysofworking.Weactasanextensionoftheir team,focusingonwhatmatterstothemwhilefeeling empoweredto"runtheextramile"todeliveroperational excellence.
Thisisnowmoreimportantthaneverasweseewhathas beenhappingtotheCROenvironmentoverthepasttwo decades,withsomanymergersandacquisitionsresultingin hugeCROswithinflatedstructures(andcosts)thatsurely canstillserveasetofsubstantialclientsbutnolongerfitsto servesmallbiotechs,pharmacompaniesandhealthcare start-upsgiventheirveryparticularneedsintermsofcosts, flexibility,senseofurgencyandattention.
UnlikemostCROs,ourkeydriverisnotrelatedtoshorttermfinancialgoals.However,long-termcustomer satisfactionandwebringthattodailylifethroughtheway weshapeourKPIs,qualitycontrolstrategies,andriskbasedthinkingineverythingwedo.Anotherelementthat bringsouruniquemindsettolifeisthefactthatwehave madeaconsciousdecisionnottohaveabusiness development/salesteam.
Wheneverclientsreachouttouslookingforourservices, theygettotalkdirectlywithourteamofmedicaldoctors, pharmacists,nurses,biologistswhowillbedirectly involvedintheclient´sclinicaltrial/project,mostofwhom havebeenonclinicaldevelopmentfor15,20+years.
Attheendoftheday,sciencecomesfirstineverythingwe dosothatwecanachieveourmissionof"helping health innovation reaching patients faster."
Shedsomelightonyourofferingsandhowtheyimpact theCROindustryaswellasyourclients.Howyour companyprovidesresearchservicestovarious organizations?
Thevalueweaddasstrategicpartnerstoourclientsis muchmorearesultofourfocusonthe"how"ratherthanon the"what."Weareequippedtoprovideend-to-endplanning solutions,conductingandreportingclinicaltrialsfromsite
feasibilityandselectiontoprojectmanagement,regulatory submissions,risk-basedmonitoring,datamanagement, statistics,medicalwriting,amongothers.However,the meansweutilizetodeliverareessential.
Weareverymeticulouswhenitcomesdownto understandingwhatdeliverymethodscanfiteachclient bettersothatwecanoffercost-effectivesolutionstailored toeachofthemwithouthavingtochoosebetweencostand efficiencyandwithouttryingtopush"overthetop" solutionsonlytojustifywehavethem.
Our values are built upon elements that are key to delivering operational excellence with a high focus on the human aspects that make a difference in how we deliver it daily.
Whilewerelyonstate-of-the-arttechsolutionstoplanand managetrialsefficiently,oursecretsauceisourpeople,no questionaboutit.Asweliketosay,Clinergyisallabout "humanologyandtechnologyforhigh-performanceclinical development."
WhatarethecorevaluesuponwhichClinergyHealth Researchisbuilt?Whatisthevisionandmissionofyour organization?
Ourvaluesarebuiltuponelementsthatarekeyto deliveringoperationalexcellencewithahighfocusonthe humanaspectsthatareeffectiveinhowwedeliveritdaily
Theyareasenseofurgency,entrepreneurship,efficiency, caringforothers,integrity,andpassion.
Weallknowhowhardandcostlyitistoputhealth innovationintothehandsofthosewhoneededit,and,as scientists,thereisnothingmoredisappointingthan inefficienciesplayingaroleinthat.Ourmissionof"helping health innovation reaching patients faster"remindsusthat weshouldalwaysbeactingascatalystssothatweaddreal valuetotheinnovationchain.
MrTiago,pleasetellusaboutyourprofessionaltenure intheCROIndustry.
BeforefoundingCLINERGY,Ihavefulfilleddifferent clinicaloperationsroles,includingleadingtheGlobal ClinicalResearchOperationsformedicinalproductswithin aUK-basedFTSE100consumerhealthcompany
Ihadthepleasuretospendthelast17yearsdrivingand deliveringstrategicprojectsforcompaniessuchas Novartis,Abbott,EliLilly,andReckittBenckiser,helping patientshaveaccesstovalue-addingmedicinesandhealth innovationacrossmultiplegeographiclocations.
Havinglivedandworkedinbothhemispheresoneitherside oftheAtlantic,Ihaveacquiredanintimateappreciationof theculturalandregulatorydifferencesthattrulyimpact globalclinicalresearch.
Beinganexperiencedleader,shareyouropiniononhow moderntechnologieshaveimpactedtheCROsector. HowhasClinergyHealthResearchincorporatedsuch technologiesintoitsdailyoperations?
Clinicaldevelopmenthasbenefitedagreatdealfromnew techsolutionsoverthepast15years,mostnotablyoverthe pastdecade.CROshaveakeyroleinmakinginnovative solutionsavailabletotheirclientsbyutilizingdata-driven solutionstoreduceoperationalcomplexity,makebetter-
informeddecisionsaroundstudydesign,monitorworkforce assignment,andconductremotetrials.
AtClinergy,wecanembedvariouslevelsoftechnology accordingtoeachtrial´needs,fromeTMFsthatcounton machinelearningtoautomatedocumentfillingtohigh-tech risk-basedstudyexecutionsolutionsthatcavesaveupto 40%ofmonitoringcosts.
Whatwouldbeyouradvicetobuddingentrepreneurs whoaspiretoventureintotheCROspace?
Settingyourselftobeabletoactasapartnertocompanies thatoperateinoneofthemostregulatedenvironmentsout thereisnoeasytask;peopleshouldknow Themost importantpointIwouldhighlighttothoseconsidering enteringthisspaceis:tomakesurethecorevalueswhich youbelievewillsetourcompanyapartfromotherplayers aregenuinelyembeddedindailyoperations.Alltherestis easilyavailabletoanyoneelse.Inanexpensiveand complexmarketsuchasclinicaldevelopment,thecostis certainlynotpartofthetopthreedecisionfactorsformost companiesastheyknowhowmuchmoreexpensiveitcould betohaveanentireclinicaltrialfailingduetooperational flawscomparedtopayingabitmoretohaveapartnerwho candeliverhighstandardsbytheirside.
Howdoyouenvisionscalingyourorganization's operationsandofferingsin2022andbeyond?
Wehaveaclearviewwhenitcomesdowntoourgrowth expectations.Althoughthedemandisveryhigh,wehave nointerestingrowingatanycostasweknowthedangers thatcomewiththat.Wesuffernoexternalpressureto deliverbetterfinancialresultseveryquarterasaprivately heldcompany.Thatallowsustoentirelyfocusoncustomer satisfactionbasedonhigh-qualityandhigh-performance outputaskeydrivers.Wehavebeengrowingsteadily,and weplantokeepacloseeyeonthebalancebetweengrowth andexcellence.
Oscar Juan MD, PhD, Medical Oncologist, Senior Medical Manager
Genetherapyhasevolvedfrombeingsciencefiction
tobecomingarealitywiththepossibilitynotonly fortreatinghereditarydiseasesbutalsofortreating geneticallycomplexdiseases,suchascancer
Genetherapycanbedefinedasthesetoftechniquesthat usenucleicacids(DNA,RNA,ortheirvariants)toreplace, correct,orinhibitanendogenousgeneinthecellsofthe organismor,actingindependentlyofthegene,useanucleic acidtosynthesizeproteinsorenzymesthatprovidenew biologicalpropertiestocellsortissues.Theobjectiveof genetherapyistotreatoralleviateadisease.
Dependingonthetargetcellsonwhichwe´dwanttoact, wecandifferentiatetwokindsofgenetherapy:
•Germgenetherapy,whichistheinsertionofthe therapeuticgeneingermcells,suchaseggcellsinfemales andspermcellsinmales.Sincethistherapyaltersthegerm cells,finally,thechangesmoveontothenextgeneration. Thistypeoftherapycouldbeusedtodefinitivelycorrect congenitaldiseases.However,thishasnotbeendonein humansduetoitsgreatercomplexityand,especially,dueto ethicalconsiderations.
•Somaticgenetherapy,theobjectiveofthistherapyisto introduceoraltergenesinsomaticcells,i.e.,thecellsthat makethebodytissuesofmulticellularorganisms.These changesarenottransferredtoaperson´soffspring.
Dependingonhowwemanagegenes,wecandifferentiate twotypesofsomaticgenetherapy:
Ÿ In vivo gene therapy:thetherapeuticnucleicacidsare introduceddirectlyintothepatient’sbody Thevectorgeneconstructisintroducedbycell-specificdirect injectionintotissueinneed.Onceinsidethebodyand incontactwiththetargetedcells,thegeneis incorporatedintothetissue’scells,encodingthe productionoftheneededprotein. In vivo genetherapyis lesscomplexthan in vitro genetherapy.However,in general,thereislesscontroloverthetransfectionofthe geneanditsefficacy.
Ÿ Ex vivo gene therapy involvesextractingthecellsfrom thesystem,isolatingthem,growingtheminaculture, andinsertingthegenes.Afterwards,cellsarereturnedto thebodyinasimilarproceduresuchasthoseusedin hematopoieticstem-celltransplantation. Ex vivo gene therapyhastheadvantagesofallowingtochoosethe celltype,havingmorecontrolovertheprocedure,and havinggreaterefficacyingenetransfection.However, itscomplexityishigherthan in vivo genetherapy,has anincreasedcost,andcanonlyusecellsthatcangrow inculture.
Thegoalofgenetherapyistoachieveadurableexpression ofthegenetransfectedtocorrectthegenealterationthat causesthedisease.Asafe,effective,andcontrollable deliverysystemiskeyingenetherapy.Therearetwotypes ofvectors:viralvectorsandnon-viralvectors.
Virusesare,sofar,themostuseddeliverystrategy The advantagesofviralvectorsaretheavailabilityofwellestablishedprotocols,hightransductionefficiencies,and
Oscar is MD from Universitat de València, Spain (1991) and trained in Medical Oncology and Haematology at Hospital Clínico Universitario de Valencia, Spain (1995). He also holds a PhD Cum laude from Universitat de València (2002).
He has been working as Medical Oncologist since 1996 in various hospitals in Spain and most recently at Hospital Universitari i Politècnic La Fe in Valencia, Spain.
He has participated as Principal Investigator in more than 100 international trials including pivotal trials than have changed the clinical practice and paradigms in lung cancer treatment.
As a member of the Biomarker and Precision Medicine Unit, he was focused on metabolomics, epigenetic and genomic biomarkers in EGFR-mutated lung cancer patients and patients receiving immunotherapy
He joined Pivotal in January 2020 as Senior Medical Manager in Oncology. He focuses on supporting the strategic clinical development of new molecules and acts as the medical reference and medical monitor for several innovative early phases trials and provide guidance to the Clinical Project team members at Pivotal to ensure adherence to study objectives and timelines.
havingmechanismsforintroducinggeneticmaterialinto cellssystematically.Viralvectorsincluderetrovirus, lentivirus,adenovirus,andadeno-associatedvirus(AAV). Retroviralvectorwastheearliestusedandhasaminimal riskofcausinginsertionmutations.
Non-viralvectorscancarryahighergeneticload,aresafe, andgenerallyinducealowerimmuneresponse.The liposomeisoneofthemostattractivenon-viralvectorsfor genetherapeutics.Liposomehasnoinhibitionandno significantdamagetonormaltissuesandcellsaroundthe targetcells,enablingthetargetgenetobefullytransfected intothetargetcells.AfterthesuccessofSARS-CoV-2 vaccines,lipidnanoparticleshavebecomeawidelyused vectorforgenetherapy
Genetherapywasinitiallyconceivedasatreatmentof geneticdiseasescausedbymutationofasinglegene (monogenic).Hereditarydiseasesincludevariousdisorders inwhichadefectivegenedeterminesthataproteinisnot synthesizedoriselaboratedabnormally,causingmany differentclinicalmanifestationsdependingonthestructural orenzymaticfunctionofthatparticularprotein(e.g., hemophiliaA).Theseproblemscouldbesolvedwithgene therapybysupplyinganormalcopyofthedefectivegeneto theaffectedtissues.
Canceroccursduetothedisruptionofnormalcell proliferationandapoptosisprocesses.Theaimofgene therapyincancerisdifferentfromthetreatmentof monogenicdiseasesinwhichthegoalistocorrectaspecific geneticdefect.
Severalgenetherapyapproacheshavebeendevelopedfor cancermanagement,suchus:
Ÿ OncolyticVirotherapy(OV)isoneofthemost promisingapproachesfortumorimmunotherapy.OV introducewild-typetumorsuppressorgenesintocells thatlackthetumorsuppressorgeneleadingtotumor cells’lysisinducingananticancerimmuneresponse (e.g.,p53gene).
Ÿ GenesilencingtherapyusesanRNAinterference (RNAi)thatinducesequence-specificdegradationof complementarymRNA.RNAiisusedindifferentareas
ofmedicine,suchasneurodegenerativeand cardiovasculardiseases,viralinfections,andcancer Sincecanceristheaccumulationofvariousmutation typesthatregulategenenetworkspromotingcell proliferation,RNAiisanattractiveapproachtotreating tumors.
Ÿ Suicidegenetherapyconsistsinintroducingsuicide genestoexpressenzymesorproteinsthatdirectly triggerthedeathoftumorcells(thegeneencodesa proteinthatiscytotoxic)orindirectly(thegene expressesenzymesthataresensitivetoadrugthatis administeredconcomitantly).
Ÿ Chimericantigenreceptor(CAR)-Tcelltherapyisa slightlydifferentprocesswithrespecttothemoredirect formsofgenetherapy.CAR-Tcellsarealab-generated fightercellscustomizedforeachindividualpatient. TheyaremadebycollectingTcellsfromthepatientand re-engineeringtheminthelaboratoryaddinganti-cancer geneticcodetoproduceproteinsontheirsurfacecalled chimericantigenreceptors,orCARs.TheseCARs recognizeandbindtospecificproteins,orantigens,on thesurfaceofcancercells.
CAR-Tcelltherapiesarethemostcommontechnology usedinpotentialcancertherapyandrepresent49%ofthe geneticallymodifiedcelltherapiespipeline.However, CAR-Tcelltherapiescancauseseveresideeffectsbeingthe mostfrequentandseriousonethecytokinerelease syndrome(CRS).
Todate,theFDAhasapprovedseveralCAR-Tcell therapiesforhematologicaldiseases.However,challenges remainfortheuseofCAR-Tcelltherapytotreatsolid tumorsduetotheirheterogeneityandlocalizationsinthe humanbody.
Genetherapyrepresentsanoveltherapeuticapproachfor managingdiseaseswithdifficulttreatment.Monogenic diseaseshavebeentreatedsuccessfullywithgenetherapy, butcancerisacomplexprocessinwhichcellshavealtered theirnormalproliferationandapoptosis.Recentprogressin developingsafeandeffectivevectorsforgenedelivery, understandinggeneediting,andtheadvancesinadoptive immunotherapywithCAR-Tcellshasopenedupnew avenuesandstrategiesfortreatingintractablediseases.
PostCOVID-19pandemicworldhas
completelychanged.Theimpactismost severeonthehealthcareindustry,especially ontheclinicalresearchandtrialsactivitiesacrossthe globe.Thelifescienceindustrymetunprecedented challengeswhichforcedittoaccelerateinnovation, revampitstraditionalmindsetandembracedigital, virtualandonlinecapabilitiestoensureservice continuance.
Traditionally,theIndustrywasverycautious,slow andreticentinadoptingdigitalandvirtualclinical trialpractices.Itwascomprehensible,evidentand expectedsincemanyofthedevice-dependent diagnosisandtreatmentdriventherapeuticareas addedmuchmorecomplexitytothedigital,virtual, andremoteofferingevolution.Further,already established,proven,andexistingdecadeoldpractices couldnotbeabandonedorreplacedorshiftedtothe digital,virtualorremotemode.
Thisemergedasthemajorconcerninthecontinuance ofclinicalresearchandtrialniche,leadingtoalmost 87%reductioninclinicalresearchinEnglandduring thepeaktimeoffirstwave,aslaterfoundoutby UniversityCollegeLondonstudy Answeringthe questionofavoidance,theindustryopenedupits mindsettoacceptthechangingrealitiesofclinical trialsandshiftingnatureofclinicalresearchinthe post-pandemicworld.
Arapidlygrowingindustry,clinicalresearchandtrialsis advancingduetonewstudiesconductedinrecordnumbers, ever-increasingpatientparticipationexpandingtheclinical trialsubjectpool,numerousresearchsitesofexcellent quality,andahugevolumeofsuccessfultrialsoverthe yearscontributingtotheexpertiseandvalues.Further developmentoftechnicalmodulesandvariousmodalities couldimproveclinicaltrialcontinuanceanddrive innovationandchangetothehigherlevel.
However,allthesemodalitiesandmodulesmustmeetthe standardcriteria’sandbenchmarksofexcellencesothatthe safetyandsecurityofthetrialscouldbemaintainedor enhanced.Thisiswheredigital,virtual,andremote technologiescouldaidinoptimizingvariousprocesseslike sitefeasibility,pre-screeningofpatients,selectionand clinicaltrialprovidence.
Byreviewingitsowntrends,changes,pressures,upheavals, successesandfailuresduringthelasttwoandahalfyears, theclinicaltrialindustrymanagedtocomeupwithmore thanadozencoronavirusvaccines,thuspushingforward theinnovationdrivenmomentumandacceleratingthe renewedfocusbyconsideringkeyfactorsofsuccess.
Tech-Focus:
Withmanyoftherestrictionsstillbeingineffect,industry’s digitalmindednessiscontinuing.Simply,theindustryhas nowfullyadoptedanentiredecentralizedvirtualmodel attitudeorahybridapproach.Inthisnewapproach, organizationsarecompelledbythevirustocontinuewith theclinicaltrialmodalitieswhichcanofferat-homeor remotetestingfacilitiesalongwithonlinepracticesand digitaltechniques.Itwillensureclinicaltrialcontinuance forpatientsinamorecomfortable,convenient,safeand securemanner Thiswillbedonewithoutanynegative impactontheclinicalinvestigatorsparticipation.
Duringthelasttwoandahalfyearsremotepre-screening tests,e-consentpracticesandmonitoringapprovalby patientsandcliniciansisontherise.Sincetheyarenow establishedaspreliminarybenchmarksforfuture modalities,theindustrycouldfurtherleverage advancementsinpracticesbestsuitableandfeasibleacross theentirespectrumoflifescienceindustrytofurtherdrive safe,secure,flexible,patient-centric,comfortable, convenient,andefficientclinicalresearchandtrial
modalitieswhichwillconstantlykeepimprovingthefuture performanceofclinicaltrials.
Itwillprovideaprimaryfoundationforthebothhybrid modelledandfullyvirtualresearchandtrialenvironments whichwillbecompletelyequippedwithprecisetools, adequatetechniques,robustandseamlessinfrastructure,a well-integratedecosystem,andbig-dataanalytical methodologies.
Whencross-functionalentitiesworkjointly,alltherelated stakeholderscouldparticipateinofferinginputs,gaining information,andmutuallyassessingthedevelopmental approachestoincreasetheresultacceptanceamidstthe changingmarketdynamics.Thisiscrucialwhenderiving digital,virtualandremoteclinicaltrialeffectiveness assessment.
Astheyhaveeasyaccesstopatients,clinicalinvestigators, sites,andsponsors,partnersofClinicalResearch Organizations(CROs)canpromptlyfacilitatefurther enhancementsindigital,virtualandremoteclinicaltrials conductionssuccess.
Beforethepandemichappenednotanyexpertwouldhave beenabletopredictthefutureofhealthcareindustryforget ofclinicalresearchandtrialindustry Althoughthe pandemicisunprecedentedinitsdevastation,onethingit didgoodisthewayitdivertedtheentireprogresspathof sectorworldover.
Thepossibilities,opportunities,andprobabilitiesithas openedupisanunimaginablypositivefutureinitself.The journeyhasmerelystarted.Wecouldpushtheboundaries ofnowestablishedinnovationfurther Thiswaywecould exploresomeunexploredareasintheclinicaltrialswith manyCROscomingtogetherandcreatinganupbeat ecosystemwhichwilloperatelikeanindustryorganwhich willfacilitateafuturewheregloballyinnovativemodalities couldbeestablished,enhancedandadvancedsothat wheneveranyunprecedentedcrisissituationwillarrivein thefuture,theindustryasawholeandtheworldasunited willbeabletocombat.
-Anish Miller
Clinicaltrialsarecarriedoutbycontractresearch
organizations(CROs)forthepharmaceutical, medicaldevice,andbiotechnologybusinessesas wellasforacademicinstitutions,governmentalagencies, andfoundations.UsingaCROforoutsourcingreducesthe amountoftimeneededforclinicaltrialsandproduct development.
Whencomparedtoconductingthetrialinternally,working withaCROfrequentlyresultsinsignificanttimesavings. Thetoolsandresourcesneededarealreadyavailableto CROs,andtheyalsohaveastaffofinternalexpertswith experienceinallfacetsofclinicaltesting,development,and compliance.
Withmorethan20yearsofexperience,OnQResearchisa full-servicecontractresearchorganization(CRO).Itis dedicatedtoofferingpharmaceutical,biotech,otherCROs, andalliedbusinessesinnovative,affordable,anduseful clinicalresearchservices.OnQResearchwasestablishedin 1999andhassincecarriedoutmorethan500clinicaltrials insouthernEuropeandmorethan10Africannations.
WithoutthechancetoincorporateotherAfricannations, SouthAfricacannotbeviewedinisolation.Mozambique, Botswana,Rwanda,Ghana,Uganda,Kenya,andTanzania arejustafewoftheAfricannationswhereOnQResearch hasconductedextensiveresearch.Thisentailsassessinga newregionandassistinginthecreationoffull-fledged, qualifiedclinicalresearchsitesthroughsiteevaluationand resourceandcapacitybuilding.Successinallclinicaltrials ontheAfricancontinentisguaranteedbyitsdistinctive ClinicalMonitoringTeamconceptandclinicalstudy approach.Thecompanyisknownforproducing high-qualityresearchquicklyandeffectively
ClientscancentralizeresearchacrossAfricawiththehelp ofOnQ.Duetoitsextensiveexpertiseandexperience,it canprovideexcellentpatientcare,lowerrisk,andsuperior datamanagement.OnQ'sclinicalresearchteamisspread acrossallofthemajorcitiesineachnation,allowingitto beflexibleanddeployresourcesasneeded.
UndertheadeptleadershipofCatherineLund,the FounderandManagingDirector,OnQResearchoffers
Catherine started her clinical research journey as a study coordinator for an RSV trial. She then joined IQVIA(then Quintiles) as a clinical trial assistant in 1996 and trained to become a CRA. She started consulting in 1999 and gradually evolved the business into a CRO. She describes herself as an accidental entrepreneur and grew the team and processes as the demand grew
Catherine Lund is the Founder and Managing Director of OnQ Research. She is, by training, a registered neonatal nurse who entered the clinical research arena as a research nurse, followed by her formal clinical research training at Quintiles. She left Quintiles to pursue a career in contracting.
Through collaborations, she then established OnQ Research, initially as a consultancy, which evolved into a full-service, SouthAfrican-based CRO in 1999. Catherine Lund has served on the SACRA(SouthAfrican Clinical Research Association) Exco for a period of three years. She was the Vice Chair for the SouthAfrican Chapter ofACRP(Annual Review of Competency Progression) in 2003.
Catherine Lund is a registered nurse with a diploma in general, midwifery, community health, and psychiatry, a certificate in neonatal intensive care, and a BAin diplomacy and political studies from B.G.Alexander Nursing College and UNISA, respectively
Catherine Lund Founder and Managing Director OnQ Research
top-notchclinicaltrialmanagementandcoordination throughCRAswithregionalbasesinallmajorcitiesinthe nationsitoperatesin.Thisensuresclosesitemanagement andreducescostlytravelexpenses.Itisperfectforallofits clinicaltrialmanagementneedsduetoitssignificant experienceincarryingoutsuccessfultrials.
Below are highlights of the interview that emphasize OnQ’s services to assist with the entire continuum of clinical research.
Catherine,pleasebriefouraudienceaboutyour company,itsUSPs,andhowitispositionedasareliable nameintheCROsector?
OnQResearchisaSouthAfrican-based,organicallygrown CROservicingprimarilytheAfricancontinent.OnQ Researchpridesitselfonofferingitsclientsablendof innovation,adaptabilitywhileaddingrealvaluewithour highlytrainedstaff.Weusescienceasthebasicpremisefor ourserviceswithoutcompromisingonquality.
OnQResearchdoesnothavea“onesizefitsall”approach.’ Thisappliestoallaspectsoftheclientrelationshipand interface,frombudgetstosizesofteams,systemsand processesoffered,andlevelsofengagement.
Shedsomelightonyourofferingsandhowtheyimpact theCROindustryaswellasyourclients.Howyour companyprovidesresearchservicestovarious organizations?
Weofferassistancewithprotocolinceptionanddesign, liaisingandobtainingappropriateHealthAuthorityandIRB approvals,selectinghighqualitysitesthroughourextensive networks,projectmanagement,monitoring,data management,andmedicalwriting.
Whatarethecorevaluesuponwhichyourorganization isbuilt?Whatisthevisionandmissionofyour organization?
OurcorevaluesareEmpowerment:Weempoweremerging biotechandpharmacompanieswithtools,resources,and
expertiseforclinicaltrialexecution.Internally,wealso applythesamevalue.Wearepassionateaboutcareer growthandofferingpotentialcandidatesopportunitiesto addvaluetoourorganization.Collaboration:OnQ collaborateswithsponsorsandclientstodrivecosteffectivedeliveryofclinicaltrials.Quality-focused.Weare committedtotheethicalconductofclinicaltrialsand deliveringqualitydatafordrugregistration.
Beinganexperiencedleader,shareyouropiniononhow moderntechnologieshaveimpactedtheCROsector. Howhasyourcompanyincorporatedsuchtechnologies intoitsdailyoperations?
Wemakeuseofcarefullyselected,fit-for-purposesystems forday-to-dayclinicaltrialmanagement.WeuseaCTMS forprojectmanagementtrackingandareintheprocessof implementingalocallydevelopedlearningmanagement systemandqualitymanagementplatform.Asourcompany grows,theimplementationofnewtechnologiesiscrucialto improvingefficiencies.Still,itrequirescarefulrisk-benefit considerationstoensurethatweremaincapableof deliveringahigh-qualityproductatacompetitiveprice.
Whatwouldbeyouradvicetobuddingentrepreneurs whoaspiretoventureintotheCROspace?
AlthoughIam,ofcourse,biased,thisisoneofthemost excitingindustriesinwhichtoventure.Networkingiskey. Attendingasmanyconferencesasyoucanandaccessingas muchinformationasyoucan.Understandwhatpartofthe CROspaceexcitesyouandwhereyoucanseeyourfuture path.
Howdoyouenvisionscalingyourorganization’s operationsandofferingsin2023andbeyond?
Ourcompanyisverydeliberateinitsfocusonbeingthe premierCROinAfrica.Ourplantoachievethisistobe intentionalaboutinvestinginourstaffandunderstanding thatallourclientsrequireabespokeanduniqueservice.
Pleasegiveusafewtestimonialsofyour clients/customersandalistofawards/recognitionsthat accuratelyhighlightyourorganization’spositioninthe market.(Ifavailable/permissible)
Ourclientsconsistentlyoffersimilarfeedbackinthatthey enjoyworkingwithourorganization,whichisflexible, adaptable,andupforanychallenge.Ithasbeenbroadly indicatedthatwehavea“can-do”problem-solving approachtoconductingclinicalresearchwithout compromisingonqualityoutcomes.
OnQ Research prides itself on offering its clients a blend of innova on, adaptability while adding real value with its highly trained staff.
