Amalgamation of Innovations and Credibility R A Role o the F Resear Industry The Impact o Technologies on the Pr e Prof Yves Henrotin Founder ExecutiveandPresident Artialis
CROs Futuristic Leap Into A Healthier Tomorrow
andthroughTheReportlinker'sCROduringThedrivenincreasedregulationsinthemarketTograspfuturethis Watch thisassistinginnovators
NoteEditor’s
uringtheCOVID-19pandemic,ifclinicians,Dhealthcareservice-providingstaff,nurses,and doctorswerebattlingattheforefront,thenthe ClinicalResearchOrganizations(CROs)havebeen workinghardinthebackgroundtodevelopeffective vaccinestofightthisnovelcoronavirus. Withmillionsofcasesemergingeverydayglobally,the demandforquickvaccinationraisedtheexpectationsfrom theCROstorisetotheoccasionandintensifytheirvaccine research,clinicaltrials,testinganddevelopmentalefforts, whichtheydidinarecordtime. Becauseoftheirtremendousefforts,globalunitcameup withnearlyadozenvaccinesalreadybeingdeployed worldwide,withoversixty-eightpercentglobalpopulation vaccinatedatleastonce. ThesearetremendousachievementswhiletheseCROsare furtheradvancingtheirforcestofindmorepossibleways
w 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 2022.'ThesetenCROsareamongthedisruptive innovatorswhenitcomestoclinicaltrials,R&D,and assistingthevaccinedevelopmentdrive.Alsoincludedin thiseditionaretwotrendyarticlesourin-houseeditorial teamcuratedtogiveyouaholisticviewoftheentire Flipscenario.throughthefollowingpagesandwitnessCROs' futuristicleapintoahealthiertomorrow;enjoy!-AnishMiller
18 Role of CROs in Shaping the Future of Clinical Research Redefining Advancements 32 08 The Impact of Emerging Technologies on the Pre-Clinical CRO Market Industry Sagacity CoverStory Articles C O N T E N T S Amalgamation of Innovations and Credibility Artialis Bionical A
14 Bionical Emas Advocators of Development and Innovation 22 Clinergy Health Research Providing Synergic Solutions for win-win Outcomes 36 PharSafer® Committed to Pharmacovigilance & Patient Safety Providing with a Heart that Cares Advancing Innovation and Patient-Centric Models CXO 26
Co-designer Paul Belin Art & Picture Editor Sonia, Mrunalinee Art & Design Editor-in-ChiefHead Pooja Bansal Managing Editor Abhishaj Sajeev Senior Editor Anish Miller Visualiser David King Rohil Shinganapurkar Circulation Manager Tanaji Research Analyst Eric Smith Sarah Wilson, John Smith, Alex VincentBusiness Development Executives Amy JonesBusiness Development Manager Sales Executives Kelli, Bill, Anna SME-SMO Executives Atul, Gemson Digital Marketing Manager Alina Sege Technical Consultants David, Robert Technical Head Jacob Smile Marketing Manager John Smith Assistant Technical Head Amar Sawant Assistant Digital Marketing Manager Renuka Kulkarni Copyright © 2022 Insights Success Media and Technology Pvt. Ltd., All rights reserved. The content and images used in this magazine should not be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior permission from Insights success. Reprint rights remain solely with Insights Success Media and Technology Pvt. Ltd. Insights Care is powered by Insights Success Media and Technology Pvt. Ltd. May, 2022 Follow us on : www.facebook.com/InsightsCare/ https://twitter.com/Insightscare Insights Success Media Tech LLC 555 Metro Place North, Suite 100, Dublin, OH 43017, United States Phone - 302-319-9947 Email: info@insightscare.com For Subscription: www.insightscare.com Insights Success Media and Technology Pvt. Ltd. Office No. 22, Rainbow Plaza, Shivar Chowk, Pimple Saudagar, Pune, Maharashtra 411017 Phone - India: 7410033802, 74100058552 Email: info@insightscare.com For Subscription: www.insightscare.com Assisting Editors Trishika, Vinayak sales@insightscare.com Corporate Offices: NDA
LinkMedicalResearch OlaGudmundsen,CEO LINKMedicalisafull-serviceNordicCROproviding productdevelopmentservicesforthepharmaceuticaland medicaldeviceindustriesacrossNorthernEurope.
CLINERGYisaCollaborativeResearchOrganizationoffering tailoredsolutionstodriveoperationalexcellencebyaddressing keypainpointsgenerallyoverlookedbythetraditional outsourcingmodel,helpinghealthinnovationreachingpatients faster.
CatherineDirectorLund, OnQResearchwasfoundedmorethantenyearsagoasa monitoringconsultancy.Ithassinceevolvedintoafull serviceContractResearchOrganization.
P.R.I.S.M.A.-CROGmbH GernotMDCremer, PharSafer Dr CEOLadds,GraemeDirector,andOwner PharSaferprovidestailoredsolutionstoactasacomplete pharmacovigilance,cosmetovigilanceandmedicalservices department.
DescriptionFeaturing ArtialisSA ProfYvesHenrotin, Founderand PresidentExecutive Artialisprovidesscientificexpertise,R&Dsupportservices, andtoolsfortheevaluationofclinical,structural,and biologicalimpactofacompoundonmusculoskeletalhealth.
Biomapas AudriusCEOSveikata, AcompletespectrumofClinicalResearch,Regulatory Affairs,Pharmacovigilance,andMedicalInformation servicesacrossEurope,CIS,EAEUandMENAregions.
NDARegulatoryScience (NDAGroup) ChristineLind, ViceCommercialPresident NDA’ssolecommitmentistomakesurethatthebestpossible medicinesreachthemarketwithoutunnecessarydelayand ensuringthattheyremainthereforaslongastheybenefitthe patients.
OnQResearch ThomasCEOOgorka, AleadingContractResearchOrganization(CRO)designed tonavigatethecomplexityoftrialsinorphanindications.It acceleratestheclinicaldevelopmentoforphandrugsand facilitatespatientaccesstourgentlyneedednewtreatments forrareconditions.
OrphanReach
reproducedLtd.or
P.R.I.S.M.A.isaGermanClinicalResearchOrganization (CRO)anddedicatedtosupporttheEuropeanportionofthe pharmaceuticalandbiotechindustries.
CompanyName 10MostInnovativeCRO'sToWatchIn2022
BionicalEmas Jonathan Waring-Hughes,CEO ClinergyResearHealthch TiagoMDdaSilva, ManagingDirector
BionicalEmasisaClinicalResearchOrganization(CRO)which combinesClinicalDevelopment,EarlyAccessProgram(EAP) andClinicalTrialSupply(CTS)servicestodeliveraunique, seamlessapproachtobringlife-changingmedicinesaroundthe world.
Artialis
COVER Story
Prof Yves Henrotin Founder and Executive President
Amalgamation of Innovations and Credibility Artiali i
clinica preclinica partneral -i -on a fro t studie .
10 Most Innovative CROs To Watch In 2022
UndertheleadershipofProfYvesHenrotin,Founderand ExecutivePresident,Artialisprovidestailor-madeclinical trialsolutions,includinginnovativeendpoints,suchas solublebiomarkers,medicalimaging(X-ray,MRI),andgait andmotionanalyses.Thisassociationofpreclinicaland clinicalexpertisereinforcesthetranslationalvalueofeach study TheLegacy ArtialisisaCRDO, Contract Research and Development Organization,locatedinBelgium. Frompreclinicalstudiestopost-marketingclinicaltrials, Artialisprovidesregulatoryandscientificexpertise,R&D supportservices,andtoolstoevaluatecompounds'clinical, structural,andbiologicalimpact.
Artiali ha hig pertis i th developmen of solubl biomarker t monitor produc efficac i animal an human .
Regeneration
AlthoughArtialisisspecializedinMSKfieldandaging relateddiseases,itisalsoactiveinotherdomainslike gastroenterologyandinfectiology.Regardingclinicaltrials, amongallthathavebeenmanagedbyArtialis,arecentone hassuitedalotofinterestandshowsmajorandpositive resultsoffoodsupplementforCOVID19hospitalized patients: Link on yahoo.com: New clinical trial shows the major and positive effect of food supplement in hospitalized patients with COVID-19 (yahoo.com) Link on prnewswire: A new clinical trial shows the major and positive effects of food supplements in hospitalized patients with COVID-19 (prnewswire.co.uk)
Artialisalsooffersanextensiveportfolioofexclusiveand innovativebiomarkersandspecializesinselectingand validatingexternalELISAkits.Inaddition,thecompany candesignanddevelopspecificon-demandbiomarkers supportingeachstepoftheclient'sproductdevelopment.
In-vitro,Artialishasdevelopedcellculturemodels (chondrocytes,synoviocytes,muscles,boneand inflammatorycells)tostudythecytotoxicity,thecatabolic andanaboliceffects,theanti-inflammatoryproperties,and themodeofactionofcandidates.
preclinical,clinicalandbiotestingservicesto supportproductdevelopmentfromresearchtopostmarketingauthorizationstagesandisanexpertin musculoskeletaldisorders(bone,cartilage,muscle,tendon, andligament),inflammatoryconditions,andhealthyaging.
Thecompanysupportsitsclients(fromPharma,Biotech andFoodsupplementindustries)duringallstagesoftheir productdevelopmentplan.
The
TheCOVID-19pandemichasspotlightedthe pharmaceuticalsector,piquingpublicinterestintheclinical developmentprocess.Itiswidelyacknowledgedthat withouttheassistanceofCROs,theindustry'smostrecent advancementsandclinicalaccomplishmentsduringthe pandemicwouldnothavebeenconceivable.
Artialisoffersstate-of-the-artstudydesignandmanagement ofinvitroandinvivopreclinicalstudies,includinggoldstandardendpoints(macroscopy,histology)andinnovative toolsofevaluation,suchassolublebiomarkers,imaging, pain,andgaitandmotionanalyses.
CROsswiftlyadoptnewtechnology,allowingthemto deliveruniqueinsightsandrecommendationsbyfinding newandinnovativemethodstouseadvancedtoolsand tailoringthemtoeachsponsor'sneedstoensureoptimal clinicaltrialperformance.SomeCRDOsevenhavetheir distinctservices.Thisiswhere comesintotheArtialis Artialisspotlight.offers
Overthelastfewdecades,CROshaveevolvedinto morethanjustasimpleoutsourcedresourceinthe pharmaceuticalsector Theyarespecialistsinthe field,activeparticipantsinclinicaltrials,andsignificant contributorstotheindustry'ssuccess.
Significant Tworesearch the osteoarthritisunderstanding,which activities.standardizationfollow-uporTheseandandTheytissuemainganizations company"benchArtialisQualitypreclinicalfromAll Development developmentauthorization oncomprisedquantifyThisefficacydevelopmentfacilityfulfillvivo)varietycompleteoffering
Continuum
AllArticlesactivitiesarebasedonhigh-qualitystandards: fromISOcertificationstointernationalguidelines,from preclinicaltomanufacturing,skilfullyintegratedbythe Qualityassuranceofficer ArtialisisauniqueCROasitcansupportproductsfrom "benchtobedside"inallmedicalfields.Indeed,the companyrecentlybecameaCRDO, 'Contract Research and Development Organization.' Thecompanyproposesservicestosupportproduct developmentfromresearchtopost-marketing authorizationstageswithateamofexpertsensuringa completeandpersonalizedfollow-up.Artialisoffersa varietyofservices,frompreclinicalstages(invitroandin vivo)toclinicalstages,includingbiotestingservicesto fulfilltherequirementsofadevelopmentplaninthesame facility.Mostnotably,Artialishashighexpertiseinthe developmentofsolublebiomarkerstomonitorproduct efficacyinanimalsandhumans. Thiscanbeimmunoassaysormassspectrometryanalysisto quantifydrugtargetsinanybiologicalfluid.Artialisteamis comprisedofPh.Ds.Itsteamofexpertsinthefieldiskeen onofferingthebestservicesonthemarket.
and clinicalgaiteach Development managementclinical,R&Dgold-innovativecatabolicandandtrials,one patientsandmajor
ContinuumofQualityAssuredServices
Twoscientificsocietieshavesignificantlyimprovedclinical researchonosteoarthritisandcartilageregeneration. It is the Osteoarthritis Research Society International (OARSI), whichistheleadingmedicalsocietyforadvancingthe understanding,earlydetection,treatment,andpreventionof osteoarthritis(OA),andthe International Cartilage Regeneration and Joint Preservation (ICRS), whichisthe mainforumforinternationalcollaborationincartilaginous tissueresearch. Theyhaveproducedaseriesofguidelinesforthedesign andconductofclinicaltrialsandforassessingtissuelesion andcartilagerepairinanimalmodels. Theseguidelinesarehelpfulforclinicalresearch organizationsactiveintherheumatologicalfield.The follow-upofthoseguidelinesallowsabetter standardizationofthepreclinicalandclinicalresearch activities.
SignificantEnrichment
"Tdevelopmentphases.estimate"Thinkpreyallowgoodogoodroad. Henr
Thesetwoareasareincluded inourstrategicplanand constituteapriorityforour company Ar alis is a human-size company with sixteen employees, each an expert in their field of work. The execu ve commi ee is comprised of four people bestowed below: Prof Yves Henro n: Founder, Chairman of the Board, and PrPresidentofYvesHenro n is a professor of Pathology, Physical Therapy, and Rehabilita on and Director of the musculoSKeletal Innova ve research Lab (mSKIL, www.mskil.be) at the University of Liège (Belgium). He is the ‘Head of the Physical Therapy and Rehabilita on Department’ at the Princess Paola Hospital (Vivalia, Belgium), an ac ve member of the Osteoarthri s Research Society Interna onal (OARSI), the French Society of Rheumatology, the Interna onal Car lage Repair Society (ICRS), and the European Viscosupplementa on Consensus Group (EUROVISCO). He is also the founder and President of The Osteoarthri s Founda on (www.osteoarthri s Drfounda on.eu)BéréniceCostes: Chief Opera ng Officer Dr Bérénice comprehends ten years of experience in academic research and more than 12 years of experience in the life science industry. She is a specialist in clinical research with exper se in musculoskeletal and age-related disorders. Dr Melanie Uebelhoer: Chief Scien fic Officer With 14 years of experience in academic research and two years of industry experience in a CRO, Dr Melanie is a specialist in R&D ac vi es with exper se in managing large team-driven research projects and scien fic Drcommunica on.SandraPietri: Chief Business Officer Dr Sandra is a specialist in non-clinical and R&D ac vi es with exper se in orthopedics and musculoskeletal disorders. She comprehends eight years of experience in academic research and eleven years of industry experience in a Cell therapy company
Exhibiting Excellence treatmentrepartitionThisanalysispartnertheusclinical"Wetorapidrecruitment.TimeweInpreclinical,functionalkeyspecificimmunofluorescence)largerpreclinical,onetechnologiesRecentlyanalysesaction Words healthcarAdvising
Importantly,Artialisownsahightechnologicalplatformto evaluatetheefficacyoftreatmentsonpain andmobility duringinvivostudies.Artialishelpsyoudesignyour researchanddevelopmentplaninlinewiththeproduct Artialispositioning.isuniqueasitdevelopsbiologicalanalysisallowing ittomonitorproductefficacyduringallstagesofits development.Furthermore,thecompanyoffersa translationalapproachfromcellstopatientswhile respectingthehighestqualitystandardsandregulatory requests.
PearlsofWisdom Sharing his opinions on how the adoption of modern technologies like AI and ML is impacting the CRO industry, Prof Yves Henrotin said,"ArtificialIntelligenceand MachineLearningarepartofourstrategicdevelopment "Wplan."eareamemberofalargeEuropeanconsortiuminwhich AIandMLareusedtodevelopanalgorithmtoidentify patientphenotypeandpredictdiseasedevelopmentand treatmentresponses.Wearealsolookingforapartnership toco-developanalgorithmpredictiveofsubjects'responses toplaceboortosimulatepatientcohorts.
Artialisoffersalargepanelofcellcultureandpreclinical models(invivo)forstudyinginnovativetreatments.
"Wehavealsojustcompletedthedigitalizationofour clinicalandpreclinicalactivities.Thisachievementallows ustosavetime,limitdatatranscriptionerrors,andimprove thequalityofourservices.Incollaborationwithalocal partner,wehaverecentlydevelopedanapplicationallowing rapidscreeningofpatientsandthusaccelerating Trecruitment.imeisimportantforourcustomers,andwedoeverything wecantoreducethedurationofclinicalstudies."
"Thinkcarefullyaboutyourdevelopmentplanandcorrectly estimatethedurationandcostsofthedifferentdevelopment phases.Tofindenoughfundstosupportproduct developmentandagoodfinancialorindustrialpartner."
WordsofInspiration Advising the budding aspirants willing to venture into the healthcare niche, Prof Yves Henrotin shared, "Tohavea goodprototype.Avoidjumpingintooquickly Thiswill allowyoutomaintaincontrolofyourprojectandnotfall preytofinancialpredators."
"Tobedetermined,courageousandpatientandtofinda goodpartnertoaccompanyyouonthislongandwinding road.ThisisexactlythemissionofArtialis."- Prof Yves Henrotin. cultur an preclinica model (i viv ) for studyin treatment .innovativ
Artiali offer larg pane of cel
RecognitionofAchievements ArtialishasbeenlistedamongsttheTOP10Bioanalytical servicescompaniesinEuropein2021byLifeSciences
ReviewArtialisislistedonICHGCPasaClinicalResearch Artialisorganization.isaccredited"CréditImpôtRecherche"and"Crédit ImpôtInnovation"allowingFrenchcompaniestofinance theirresearchanddevelopmentandproductdevelopment Artialisactivities.isISO9001compliant,guaranteeingthequality processesandthesatisfactionofitscustomers. Artialis'animalfacilityisaccreditedAAALAC.Thatmeans thatArtialiscomplieswiththestandardsforhumane treatmentofanimalsusedinresearchandtesting.
TheexecutiveteamplanstomultiformtheMSKbusiness withgastroenterology.Inthisway,Artialisexpectsto doubleitsturnoverin2025.Thecompanyenvisionshaving anaffiliateofficeinstrategiccountriestoextendits operationworldwide.
Inpreclinical,AIisusedroutinelytoquantifystructuraland functionalparameters.Forstructuralchanges,histologyisa keyparameter;AIhelpsrapidlyandaccuratelyquantify specificstaining(standardhistology)ortargets(using immunofluorescence)andallowstogaintimeandquantify largerregionsofinterest.Forfunctionalevaluationin preclinical,AIisusedfortheDigitalWeightBearing analysisandduringthein-lifephaseofanimals. Thisanalysisallowsonetoregistertheanimalweight repartitiononthefourpawsandclearlyidentifythe treatmentefficacyonthisparameterinOAmodels.Finally, oneofArtialiscommitmentsistokeepawatchon technologiesallowingtissuesandbiologicalanalysis.
allowingto industry, partnershipwhichresponses
Recently,theorganizationhasmanagedproteomics analysesofmanyseratoidentifydrugtargets,modeof actionofthedrugandidentifycompanionbiomarkers.
EmbracingtheFutureRoadmap
Early Access Programs (EAP)
Theirwiderangeofservicesenablesthemtomaximize accessandgenerateevidenceateverypointalongthedrug developmentpathway Thismeanstheycansimultaneously addresstheimmediateandfutureneedsofpatients.
AnExemplaryLeadership JonathantookontheroleofBionicalEmas,CEOin2018 andisresponsiblefortheoverallrunningandperformance ofthebusinessglobally.Sincejoiningthecompanyin 2013,hehasbeenanintegralpartandfoundingmemberof theorganization.Heisextremelypassionateanddrivenby thecompany'smissionofpioneeringthewaylife-changing medicinesaredevelopedandaccessedforpatientsaround theworld. HeinitiallyfoundedandheadeduptheClinicalTrial Supply(CTS)divisionintheUKbeforespendingtimein theUSsettingupBionicalEmasInc.andofferingservices fortheUSmarket.Hehasplayedanessentialrolein creatinganddrivingtheglobalcommercialandoperational strategywhichhasseenthebusinessgrowfrom15people in2013toover200in2022,withoperationsacrosstheUS, EU,UK,andAustralasia.
14|www.insightscare.com 10 Most Innovative CROs To Watch In 2022
Bionical Emas
ThecompanyrunsglobalPhaseItoPhaseIVclinicaltrials foritsinternationalpharmaandbiotechclientsandhasan oncologyandrarediseasetherapeuticfocus.Inaddition, throughoutthepandemic,ithasalsobeenheavilyinvolved intherunningofCOVID-19studies.
BionicalEmasEAPistheonlyspecialistEarlyAccess Program(EAP)partnertoharnessthefullpowerofan May 2022
TheThreeCoreBusinessUnits
Standingasaguidinglighttothisinnovativepathis JonathanWaring-Hughes,asitsChiefExecutiveOfficer.
BionicalEmasimplementtraditionalanddecentralized clinicaltrialmodels,utilizingitsglobalin-houseteamsof clinicaldevelopmentprofessionalsandinnovative technologiestopioneerthewaymedicinesaredeveloped forpatientsaroundtheworld.
BionicalEmasoperatesasafullyintegratedservices businessbasedaroundthreecorebusinessunits,whichare madeupofawiderangeofproductandservicelines.
ithrapidadvancementsintechnologiesWalongsidetheever-increasingneedfordrug development,ContractResearchOrganizations (CROs),havesignificantlyinfluencedthelandscapeof biotechandpharmadevelopment.Theyarekeepingupthe pacetoprovideacutting-edgesciencetofacilitatethe growingneedsofthefield. Furtheringthisever-increasingneedtodesign developmentalstrategies,BionicalEmasprovidesservices thatcatertotheclient'sdrugandpharmadevelopment needs.BeingaglobalContractResearchOrganization,what makesthecompanyuniqueisthatitcombinesclinical development,earlyaccessprogram,andclinicaltrialsupply capabilitiestodeliveranexceptional,seamlessservicefor itsinternationalpharmaandbiotechclients.
Advocators of Development and Innova on
Clinical Development
JonathanisaremarkablyyoungCEO,provingthatsuccess inrunningabusinessdoesn'thaveadirectcorrelationwith aspecificprofileoragegroup.Histalent,passion,and aspirationtomakeapositivedifferencewererecognisedby theBoardofDirectorsasthekeyattributesofagreatleader Hissuccessfultenureintheroleisproofthatinnovative thinkinginabusinesscontext,particularlyatthePeople level,canpay-off.JonathanmanagesBionicalEmasunder thesameapproach,whichresultsinahighlydiverseand inclusivecompany,wherecareerprogressionisareality andwomeninseniorleadershiprolesisthenorm.Underhis exemplaryleadership,thecompanyoperatesonfully integratedservices.Letushavealookatthem.
Jonathan Waring-Hughes Bionical Emas
CEO
Emas developedoperationalpeopleUS,successwithbyleaderunderhisaretrialsaninvolvedof 2022 2022 The company has seen a huge movement toward hybrid clinical trials, pu ng the pa ent's comfort first and mee ng pa ents where they are.
Theglobalnetworkofmanufacturerpartnershipsenables thecompanytodeliversustainableandreliableaccessto medicinesandancillariesforclinicaltrialsponsors, healthcareprofessionals,andpatientsglobally DeliveringExcellentServicesthroughitsDrivenMission
AdoptionofModernTechnologies
BionicalEmasprovidesunrivaledaccesstomedicinesand ancillariesforuseinclinicaltrials.Itofferscustomizedendto-endsupplysolutionsforitsinternationalpharmaand biotechcustomerbase.
BionicalEmashasmadeasignificantinvestmentin technologies,soitcanmeetthesponsor'sneedsinrunning clinicalstudies.ThecompanyisusingMachineLearning (ML)toreviewdatacapturedfromsitesandidentifyany trendsand/oranomaliestooptimizethedigitalclinicaltrial pathway.Jonathanasserts, "We are using Artificial Intelligence (AI) to speed up recruitment and feasibility process, minimizing manual and repetitive tasks and fundamentally improving patient adherence."
AccordingtoJonathan,"Moderntechnologieslike blockchain,sensingtechnologies,ArtificialIntelligence (AI),andMachineLearning(ML)arehavingahugeimpact onthewaythesectorisoperating."Hebelievesthatthese technologiesarehelpingtoimproveagility,quality,and patientadherenceandfundamentallyreducingthecostof runningclinicalstudiesbutkeepingdatafullysecure. Thesetechnologiesarealsohelpingclinicaltrialactivities tobeshiftedclosertothepatient.TheCOVID-19pandemic hasforcedthesectortoincreasetheadoptionofthese technologiessignificantly.Thecompanyhasseenahuge movementtowardhybridclinicaltrials,puttingthepatient's comfortfirstandmeetingpatientswheretheyare.
Whentalkingaboutscalingthecompany'soperations, Jonathanstates, "Our strategy is to drive organic and acquisitive growth by developing and cross-selling our widening portfolio of services and capabilities into our international client base and by expanding our geographical footprint."
Hefurtherstatesthatusingnaturallanguageprocessingto automaticallyidentifyadverseeventsimprovesthequality ofservicebeingprovidedtoitssponsors.Thecompanyhas partneredwithsomeleadingtechnologycompaniestohelp thecompanyprovidedecentralizedclinicaltrials,givingit toolslikeeCOA/ePROandeConsenttobringthese activitiestopatients.
ANotetoRemember
ThemissionofBionicalEmasistopioneertheway life-changingmedicinesaredevelopedandaccessed forpatientsaroundtheworld. ItisthepeopleofBionicalEmasthattrulydifferentiate them,andtheirfocusondeliveringexcellenceacross theirsuiteofservicesthatleadstolong-term partnershipswithitsbroadbaseofclients,HCP's,and Jonathanpatients.states, "we are bold, creative, and driven by the fact we are changing patients' lives."
Over the coming years, I believe the focus will continue to be on further enhancing the patient experience through implementing innovative technologies and decentralized/hybrid clinical trials." Thiswillultimatelylead tofasterandmorediversepatientrecruitment. RoadmaptotheFuture
Whenaddressingthebuddingentrepreneurswhowishto progressintheCROspace,Jonathanasserts,"I would say that creating a truly differentiated offering is critical for anyone looking to venture into the space. The sector is awash with CROs of many shapes and sizes, so it is important to find a niche that enables you to differentiate against your competitors.
establishedandsuccessfulContractResearchOrganization. Arangeofin-houseservicesperfectlycomplementsits globalEAPexperienceinoncologyandrarediseaseareas. Thecompanyputsthepatientattheheartofeverythingit does.Thegoalofthecompanyistohelpcurrentandfuture generationsbyprovidingtimelyandappropriatetreatment accesstopatientsindesperateneed.
Overthepastfewyears,thecompanyhasmadesignificant investmentsinthethreecorepillarsofthebusinesspeople,infrastructure,andtechnology,whichprovidethe companywithaplatformforoperationalandgeographical expansionin2022andbeyond.Jonathanbelievesthat expandingitsoperationsacrosstheEU,USandJAPAC regionswillbeamajorfocusover2022andthecoming years. May 2022
Clinical Trial Supply (CTS)
16|www.insightscare.com
Learningrunningtrialtoqualityhashelpit sayto geographicalsignificantleadthe 2022
ClinicalResearch Role of CROs in Shaping the Future of Redefining Advancements May 202218|www.insightscare.com P reticentTtomindsetforcedscienceresearchensureraditionally 19|www
Traditionally,theIndustrywasverycautious,slowand reticentinadoptingdigitalandvirtualclinicaltrial practices.Itwascomprehensible,evidentandexpected sincemanyofthedevice-dependentdiagnosisand treatmentdriventherapeuticareasaddedmuchmore complexitytothedigital,virtual,andremoteoffering evolution.Further,alreadyestablished,proven,andexisting decadeoldpracticescouldnotbeabandonedorreplacedor shiftedtothedigital,virtualorremotemode.
19|www.insightscare.com
ements 2022
ostCOVID-19pandemicworldhascompletelyPchanged.Theimpactismostsevereonthe healthcareindustry,especiallyontheclinical researchandtrialsactivitiesacrosstheglobe.Thelife scienceindustrymetunprecedentedchallengeswhich forcedittoaccelerateinnovation,revampitstraditional mindsetandembracedigital,virtualandonlinecapabilities toensureservicecontinuance.
Thisemergedasthemajorconcerninthecontinuanceof clinicalresearchandtrialniche,leadingtoalmost87% reductioninclinicalresearchinEnglandduringthepeak May 2022
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
Asassessment.theyhaveeasyaccesstopatients,clinicalinvestigators, sites,andsponsors,partnersofClinicalResearch Organizations(CROs)canpromptlyfacilitatefurther enhancementsindigital,virtualandremoteclinicaltrials conductionssuccess.
CreatingStreamlinedEcosystem
FuturisticCROsTransformingtheClinicalResearch
TheChangingDynamicsofClinicalResearchIndustry
Thepossibilities,opportunities,andprobabilitiesithas openedupisanunimaginablypositivefutureinitself.The journeyhasmerelystarted.Wecouldpushtheboundaries ofnowestablishedinnovationfurther Thiswaywecould exploresomeunexploredareasintheclinicaltrialswith manyCROscomingtogetherandcreatinganupbeat ecosystemwhichwilloperatelikeanindustryorganwhich willfacilitateafuturewheregloballyinnovativemodalities couldbeestablished,enhancedandadvancedsothat wheneveranyunprecedentedcrisissituationwillarrivein thefuture,theindustryasawholeandtheworldasunited willbeabletocombat. -GauravPRWankhade
May 202220|www.insightscare.com
timeoffirstwave,aslaterfoundoutbyUniversityCollege Londonstudy Answeringthequestionofavoidance,the industryopenedupitsmindsettoacceptthechanging realitiesofclinicaltrialsandshiftingnatureofclinical researchinthepost-pandemicworld.
Beforethepandemichappenednotanyexpertwouldhave beenabletopredictthefutureofhealthcareindustryforget ofclinicalresearchandtrialindustry Althoughthe pandemicisunprecedentedinitsdevastation,onethingit didgoodisthewayitdivertedtheentireprogresspathof sectorworldover
environmentsacrossdrivefuturearelatedderivinginvestigators,havegetitofTheboundariescouldwhichmodalitiesinunitedankhade 2022
heHealthcareindustryusuallyfacesproblemstoTbridgethegapandsolvetheproblemspromptly, isn'titsomethingthatshouldbetakencareof?
Clinergy Health Research
Attheendoftheday,sciencecomesfirstineverythingwe dosothatwecanachieveourmissionof"helping health innovation reaching patients faster."
Providing Synergic Solutions for win-win Outcomes
Shedsomelightonyourofferingsandhowtheyimpact theCROindustryaswellasyourclients.Howyour companyprovidesresearchservicestovarious organizations? Thevalueweaddasstrategicpartnerstoourclientsis muchmorearesultofourfocusonthe"how"ratherthanon the"what."Weareequippedtoprovideend-to-endplanning solutions,conductingandreportingclinicaltrialsfromsite
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.
Acknowledgingtheseconcernsoffillinguptheoperational gapsandsolvingtheproblemsinatimelymanner, ClinergyHealthResearchhassolutionstoavarietyof managerialissueswhilealsoprovidingafullrevampofall thehealthcareprocesses. Havingthisproblem-solvingapproachandabundant experience,TiagoMDdaSilva,ManagingDirector,has scientificandmanagementknowledgetoenhancethe operationalexperienceanddeliversuperiorresults.
10 Most Innova ve CROs To Watch In 2022 May 202222|www.insightscare.com 23|
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.
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.
ealth Outcomes resultinghasdoctors,services,surelyinfitstocosts,waythatwhomwe impact than planningonsite 2022
feasibilityandselectiontoprojectmanagement,regulatory submissions,risk-basedmonitoring,datamanagement, statistics,medicalwriting,amongothers.However,the meansweutilizetodeliverareessential.
Weareverymeticulouswhenitcomesdownto understandingwhatdeliverymethodscanfiteachclient bettersothatwecanoffercost-effectivesolutionstailored toeachofthemwithouthavingtochoosebetweencostand efficiencyandwithouttryingtopush"overthetop" solutionsonlytojustifywehavethem.
Tiago M D da Silva Managing Director Clinergy Health Research
May 202223|www.insightscare.com
Clinicaldevelopmenthasbenefitedagreatdealfromnew techsolutionsoverthepast15years,mostnotablyoverthe pastdecade.CROshaveakeyroleinmakinginnovative solutionsavailabletotheirclientsbyutilizingdata-driven solutionstoreduceoperationalcomplexity,makebetter informeddecisionsaroundstudydesign,monitorworkforce assignment,andconductremotetrials.
AtClinergy,wecanembedvariouslevelsoftechnology accordingtoeachtrial´needs,fromeTMFsthatcounton machinelearningtoautomatedocumentfillingtohigh-tech risk-basedstudyexecutionsolutionsthatcavesaveupto 40%ofmonitoringcosts.
Whilewerelyonstate-of-the-arttechsolutionstoplanand managetrialsefficiently,oursecretsauceisourpeople,no questionaboutit.Asweliketosay,Clinergyisallabout "humanologyandtechnologyforhigh-performanceclinical development."
MrTiago,pleasetellusaboutyourprofessionaltenure intheCROIndustry BeforefoundingCLINERGY,Ihavefulfilleddifferent clinicaloperationsroles,includingleadingtheGlobal ClinicalResearchOperationsformedicinalproductswithin aUK-basedFTSE100consumerhealthcompany Ihadthepleasuretospendthelast17yearsdrivingand deliveringstrategicprojectsforcompaniessuchas Novartis,Abbott,EliLilly,andReckittBenckiser,helping patientshaveaccesstovalue-addingmedicinesandhealth innovationacrossmultiplegeographiclocations.
Weallknowhowhardandcostlyitistoputhealth innovationintothehandsofthosewhoneededit,and,as scientists,thereisnothingmoredisappointingthan inefficienciesplayingaroleinthat.Ourmissionof"helping health innovation reaching patients faster"remindsusthat weshouldalwaysbeactingascatalystssothatweaddreal valuetotheinnovationchain.
Whatwouldbeyouradvicetobuddingentrepreneurs whoaspiretoventureintotheCROspace?
Beinganexperiencedleader,shareyouropiniononhow moderntechnologieshaveimpactedtheCROsector. HowhasClinergyHealthResearchincorporatedsuch technologiesintoitsdailyoperations?
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.
WhatarethecorevaluesuponwhichClinergyHealth Researchisbuilt?Whatisthevisionandmissionofyour organization? Ourvaluesarebuiltuponelementsthatarekeyto deliveringoperationalexcellencewithahighfocusonthe humanaspectsthatareeffectiveinhowwedeliveritdaily Theyareasenseofurgency,entrepreneurship,efficiency, caringforothers,integrity,andpassion.
May 202224|www.insightscare.com
Havinglivedandworkedinbothhemispheresoneitherside oftheAtlantic,Ihaveacquiredanintimateappreciationof theculturalandregulatorydifferencesthattrulyimpact globalclinicalresearch.
workforcehigh-tech eneurs operationalcompaniesoutwhichplayersismostcouldwhohavedangersprivatelycustomerandgrowth 2022
Forpharmaandproviders'caresettings,likeacute,postacute/assistedlivingfacilities,theyneedtobehyper focusedonpersonalizationofdatacollection, personalizationofcaredeliverymodelsandfocusonwhere thepatientis,whichisoutsidethetraditionalclinical May 2022
Healthcareisacomplexwebofinteractionsand engagementswithlotsoftraditionalinvolvements betweenpatients,providers,payers,andpharma. However,changeisintheair,especiallyinorthopedics, withdigitaltransformation,digitalinnovation,andpatientfocused Innovationmodels.isdesperatelyneededinallareasofhealthcare.
The paradigm shift: Go beyond the traditional, follow the patient!
Still,bigfootapproachesthatdisregardexistingpatientand clinicalcaredeliverymodelsratherthantryingtotransform themwillultimatelyresultinminimalsuccess.Learning fromtheirownpastfailures,aswellasthefailuresofother bigtech,willgoalongwaytowardsensuringcontinued innovationandgrowthinorthopedicmedicine.
Ÿ Paradigm Ÿ Positioning Ÿ Process Ÿ Product
26|www.insightscare.com unnecessarexresearchArtimarkdesign-thinking,sitsinnovationbusinessentrepreneurArtitechnologygrowth,ecution,consumerssocio-economicengagementIn2017,healthcaredesignchangehealthcareThecompaniestransform.businesses,healthcareideatewithbettercreativepracticalclientsPriorconsultancleadershipGlassdoorSheKelloggNorthwesternbachelor'scommunicationStateEnglish,Punjabi. ARTI About 27|www
Innovationisnolongeranideaforhealthcareandlife sciencesbutawayforward,aswrittenbyMichiganState University'sProfessorJoeTiddandJohnR.Bessant,with additionalresearchpublishedintheInternationalJournalof HealthPolicyandManagement. Theirresearchfocusedon theFourPsofdrivinghealthcareinnovationandpatientcentricmodels.
ArtiBediPullinsisastrategic,data-driven entrepreneurwith20yearsofexperiencein businessstrategyanddeployment,product innovationanddigitalmarketing.Herpassion sitsattheintersectionofcustomer-based design-thinking,innovativetechnology,and marketdata/research. Artihasarchitectedandledoveradozen technologybusinessestowardssuccessful growth,appliedmarket,customer,andproduct researchdatatothedevelopmentofin-market execution,andworkedonminimizingriskand unnecessarycostsbyunderstandinghow consumers'emotions,interactions,culturaland socio-economicdemographicsimpactbrand engagementandadoption. In2017,ArtifoundedPunditConsultantz,a healthcareinnovationandcreativeservices designconsultancy.PunditConsultantzisthe changeagentandproblemsolverfor healthcareandlifesciencesclients.
onof the where 2022
Thefirmworksexclusivelywithhealthcare companiestoincubate,innovate,anddigitally transform.PunditConsultantzhelps businesses,institutionsanddevelopersin healthcareandlifesciencestechnology ideateandthenbuildproductsandservices withreal-worldapplicationstoproduce betteroutcomes.Thecompanyalsohas creativedesignservicesthatexecute practicalgo-to-marketstrategiesfor clients'productsandservices. Priortofoundingherbusiness consultancy,Artiheldsenior leadershiproleswithSessionM, GlassdoorandCareerBuilder.com. SheearnedanMBAfromthe KelloggSchoolofManagementat NorthwesternUniversityanda bachelor'sdegreeinbusiness communicationfromMichigan StateUniversity.Inadditionto English,ArtiisfluentinHindiand Punjabi.
ARTI BEDI PULLINS About the Author May 202227|www.insightscare.com
setting. BigtechandMedTechhaveprovenagainand againhowindustriesoutsideofhealthcarearemeeting wheretheconsumer,inthiscase,thepatientis. Patientsnolongerneedtoaphysicalfacilitytoachieve personalcarebutratherdemandconvenience,comfort, accessibility,andaffordability,alldrivenbyinnovations.
SmartTVsareownedby67percentofadultsage50and older,35percentownhomeassistants,30percentowned wearablesand23percentownedsmarthometechnology, asdescribedinTrendsAffectingTechnologyAdoptionin Post-AcuteandSeniorCare.Meetingthepatientintheir homesandinvirtualcaresettingsbydeliveringhybrid patient-centricmodelswillfurtherhelpdeliverthe underlyingvaluechain.
Product: Innovating to drive better health Creatingbetterresultsandoutcomesforpatientsis ultimatelywhateveryonewithinthehealthcareecosystem is Forafterorthopedictechnologyandorthopedicmedicine,the advancementinsensor,MedTechandartificialintelligence isoneofthedriver'sdeliveringsuccess.Justlookathow smartorthopedicimplantsarehavingtheirmoment(page 14-17)publishedinMedTechstrategist. MedTechandmedicalmanufacturersareembeddingsmart sensortechnologyandutilizingreal-worldevidencetolearn andimprovetheirproductoutcomesduringandaftera surgicalprocedure,dramaticallyshorteningpatients'postsurgeryrecoverytimes. Whetherhealthcareandlifescienceschoosetoimplement the4-Psorincorporateadifferentprocess,steadyand constantlearningfromcomplementaryindustriesand verticalswillfuelinnovationandpatient-centricmodels.
May 202228|www.insightscare.com
Position: Be patient-focused and personalized careobsessed Anybigtechcompany,likeAmazon,Uber,Microsoft, Apple,andFacebook,areobsessedwiththeirproductsor service'sbeingpositionedbasedontheircustomerneeds andwants,sometimesbeforetheyevenknowtheyneedit!
Healthcare,pharma-baseddrugs,andtherapydevelopment shouldbeno Consumer/patientdifferent.care,engagementandpersonalizeddata transparencyneedstobelookedatfromacompletepatient carejourneyperspectiveandallpartsofthehealthcare ecosystem.AsPatrickMcGillsharedatHIMSS,at CommunityHealthNetwork,thepatientisatthecenterof theentiresystemspractice.Thereisnooneownerofpatient experience;everybodyishyper-focusedoncreatingabetter patientexperienceandultimatelybetterpatientoutcomes.
Process: To focus and partner Patientcareisnoteasy.Itscomplexityrunsfromthe collectionofpersonalizedhealthdata,agrowingyet controversialtrend,totheutilizationofthatdatatodeliver betteroutcomes.Learningfromthemanufacturing,tech, andsupplychainindustriesinimplementingautomation, businessprocesses,andtechnicaldataintegrations,canall furtheroptimizepatientcare.Healthcare'shospital-at-home programs,drivenbyMayoClinicandJohnHopkinsandlife sciencesgrowthtowardsdecentralizedclinicaltrialmodels, aspublishedbyMcKinsey&Companyandacceptedbytop pharmalikeJansenandPfizer,areallexamplesof ownershiptodrivebetteroutcomes. Digitalclinics,telemedicine,decentralizeddatacollection, andin-homeandhybridcaremodelsareprovingtobecosteffectiveandaccessiblesolutionstosolvingcomplex chronicdiseasesandthedailycareandconsumerizationof healthcare.
developmentit!datapatientofpatientbetteroutcomes.ecosystemintelligence(pagesmartlearnpost-implement 2022 Stay in touch. Subscribe to Insightscare Get Insightssuccess Magazine in print, & digital onCheckwww.insightscare.comshouldbedrawn in favor of : INSIGHTS SUCCESS MEDIA TECH LLC
TheImpactof onthe CRO Market
May
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CRO Market echnologyischangingthehealthworld'sfuture,Twhilefuturetechnologyisreshapingthepresent worldofhealth.Alreadyemergingfromthe turbulentoceansofchangingtimesarenovelwaysof carryingoutorperformingpreclinicalresearchand conductingtrials. ManygiantClinicalorContractResearchOrganizations (CROs)havealreadystartedintegratingtheirpreclinical research,testing,andtrialswithnotonlydigital,virtual, andremotetechnologiesbutarealsoimplementing ArtificialIntelligence(AI),CloudComputing,andMachine Learning(ML)technologiestoefficientlyconduct,perform, orcarryoutsuchexperimentsinincreasinglyenhanced Theenvironments.processofdevelopingamedicinalproductisalong one,wheretherearemanysubprocesseslikeideaor conceptgeneration,framing,discoveringanddeveloping thatideafurther,thenthepre-clinicalresearchstagethen comestotheclinicaltrialstage,andfinally,theFDA 2022
2022 May 202233|www.insightscare.com
AHolisticTechPerspective
ThePowerofModernTech
Itisbecauseofusingsuchnoveltechnologiesthatinjusta yearandahalf,CROsacrosstheworldcouldcomeupwith morethanadozencoronavirusvaccinesincludingSerum InstituteofIndia'sCOVOVAXwhichhasbeendeveloped throughthreetrialsinonecountryandapprovedinfive countries,COVISHIELD(OxfordAstraZeneca Formulation)developedthroughfourtrialsinonecountry andapprovedin49countries;Novavax'sNUVAXOVID whichhasbeendevelopedthrough17trialsin13countries andapprovedin38countries;Oxford/AstraZeneca's VAXZEVRIAdevelopedthrough66clinicaltrialsin31 countriesandapprovedin140countries;andsoonandso Dueforth.tothisrapidvaccinedevelopment,accordingtoThe NewYorkTimes'COVIDvaccinetracker,asofJuly2022 over5.23billionpeopleor68.2%oftheworldpopulation havereceivedadoseofaCOVID-19vaccine.
LiveCOVID-19Example
FuturisticTechnologiesistheFuture
AdvanceTechnologicalImplementationlowersthe Uncertaintyofthepreclinicalexperimentsbystreamlining andoptimizingdetaileddatacollection,easingdownthe pre-clinicaltrials'subjectselection,decreasingthetime durationofresearch,andreducingfinancialcosts.Research, datacollection,testsubjectselectionandcontinuous analysisareanintegralpartofdrugresearchandmedicine development.However,withincreasingintricacyinthe entireprocess,navigatingthroughthecontinuousstreamof incomingdatagetsimpossibleforthehumanresearcher.
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 Preclinicalprocess.image,graphics,andsamplematchingand analysisprocessautomationarealsofeasibleusingtechs suchasAIandML.CROsarenowincreasinglyusingthese technologiesforautomatedtestingsampleanalysis, identificationofmolecularcompounds,andanalysepatterns fordrugdiscovery. ForExample,AIisnowbeingusedbytheInstituteof CancerResearchformakingpredictionsregardingcancer drugs'novelprospectsandperformingrepetitivetaskslike researchrecordup-gradationanddataextraction.Likewise, scientistshavesuccessfullydevelopedEve,anAIRobotto helpresearchersinspeedingupthedrugdiscoveryprocess.
-GauravPRWankhade May 2022
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assessmentandreviewstagewhichapprovesordisapproves theproductbasedonitscriteria.
Thisiswhereadvancedtechnologieslikeautomation,AI, cloudcomputing,BigDataAnalysis,ML,etc.providenot onlymonitoring,tracing,tracking,andcollectingdatabut alsodeepandmachinelearningoftherecordeddatatooffer preciseanalysis,interpretation,flow,patternwhile matchingthesampleswithearlieravailableones.
Letuslookindetailatthesereasonsanddigourselves deepertogainabroaderperspective.
Althoughallthesesubprocessesareequallyimportant,the stagewherepre-clinicalresearchisconductedisthemost crucialoneastheprospectiveproductideasorconcepts haveastrongchanceoffailing.Thisiswherepreclinical CROsplayaverymajorroleinoptingforadvanced technologiessotheycouldresearchtillthelastelementof eachideaandconceptfromeverypossibleangle,andfind outthepossibilities,andprobabilitiesofthesuccessandthe failureofthedrugormedicineindevelopment. Moderntechnologiesarenotonlygivingmorepowertothe preclinicalCROstolookatthepreclinicaltrialprocesswith aholisticviewincreasingtheprobabilityofthedrugor medicinemovingtothefurtherstagebutarealsohelping theminsavinghugecosts.
cell-basedpopulationcountriescountryso2022usingselectioneffort,duringthesepatternscancerlikeLikewise,toprocess.ankhade 2022
Inadditiontoassistingtheclientswithauditpreparedness throughits'WhiteGlovesAuditGroup',PharSafer®offers globalmedicalservicesandindustrytrainingcoursesfor fellowindustryandregulatoryprofessionalsfrom introductorythroughtointermediateandadvancedlevels onwide-rangingtopics. Weat Insights Care gotanopportunitytointerview PharSafer®'s,Director,CEO,andOwner,DrGraeme Ladds.Hesharedsomevaluablefactsaboutthecompany showcasingthefundamentalsofbeingoneoftheprominent companiesintheCROhealthcaresector Below are the highlights: Pleasebriefouraudienceaboutyourcompany,itsUSPs, andhowitispositionedasareliablenameintheCRO sector? Foundedin2003byDrGraemeLadds,PharSafer®isan InternationalContractResearchOrganisation(CRO) specializinginGlobalClinicalandPostMarketingDrug SafetyandMedicalServices,withawealthofvaried experienceinPharmacovigilance,MedicalAffairs,and MedicalInformation–andthedifferent,numerousand extensivelegalsafetyormedicalobligationsforlicense holdersandclinicalsponsorstocomplywith.
10MostInnovativeCROsToWatchIn2022 May 202236|www.insightscare.com
CommittedtoPharmacovigilance&PatientSafety
Withtheincreasingdemandfornewerandsafer pharmaceuticalproducts,ContractResearch Organizations,(CROs),haverapidlybecomea forceindrugdevelopmentandclinicaltrialrecruitments andintothepost-marketingsafetyarena.Tohighlightone suchcompany,PharSafer®,hasquietlyandswiftly innovatedanddevelopedrobustsystemsasitsprimary routetoprovidethebestclinicalresearchfordrug developmentCompanieslargeandsmall.
Thecompanyoffersabreadthofvigilanceoperations(The A–ZforPharmacovigilance)foritsclients,rangingfrom PharmacovigilancetoCosmetovigilance,Materiovigilance, AdvancedTherapy/Biologicsvigilance,Vaccinesafety, Nutrivigilance,andVeterinaryPharmacovigilance.
Throughourfivecorebusinesssectors-Pharmacovigilance, Training,Audits,MedicalAffairs,andInformatics,our clientsalwaysknowwhotheycanspeaktoforanyrequest. Theydonotjustgetaprovider–theygetapartneroffering adviceandexpertisetodeveloptheirdrugsafetysystems cost-effectivelyandcompliantly Pleaseshedsomelightonyourofferingsandhowthey impacttheCROindustryandyourclients.Howyour companyprovidesresearchservicestovarious organizations? Inourpeopleandourprocesses,wehaveafirst-class businessanddeliveraservicetomatch.Weensureall operationsandcommunicationsareconductedwithfull transparencywithourclientstoensureasynergized approachanddeliveronourpromisetowardsproviding Inourpeople andourprocesses, wehavea deliverbusinessfirst-classandaservicetomatch.
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csistandresulttrainingGraemeinGraemeCInstitutGraemeCareasandWithonPharmacoverGraemePharmacCompanompanies,lastompaniestheirforaglobalHisavailabilityourses
GraemeisalsoamemberoftheDIA;TOPRA;RQA,andthe InstituteofDirectorsandPIPAandhashelpedsmallstart-up Companies(Biotech;MedicalDevices;Biologics;Generics;Herbal;OTC)in theirplanning,growthandhasbeeninvolvedinCompanyandproductacquisitions,duediligenceactivities forproductin-licensingandmarketinganddevelopmentstrategieswithpartneranddistributorCompanies.
Graemehasbeeninvolvedinmanydrugdevelopmentprograms,takingproductsfromthebenchtomarket inawiderangeoftherapeuticareas. GraemealsohasanadditionalroleasResearch&DevelopmentDirectorforproductstobedevelopedfor globallaunches. His31-yearjourneyindrugsafety,wheretherewaslittlestructuretobetrainedinpharmacovigilanceor availabilityforfindingouttheglobalregulations,fueledhisdesiretoensuretherewouldbeanextensive trainingprogramforallthePharSafer®peopletopromoteandsimplifytheirdrugsafetycareers.Thishas resultedinmanystaffnowhasremainedwiththeCompanyforovertenyears,providingCompanystability andin-depthexpertise.Additionally,toaidalldrugsafetyprofessionalsintheircareersthePharSafer® sisterCompanySaPharhasperformedtrainingallovertheworldwithvariedbespokeandformattedtraining coursesforalllevelsofexperiencesince2003.
Strategic and Critical Leadership DrGraemeLadds Director,CEO, PharSafOwnerer® 2022
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May
r® companyprominent CROUSPs, Pharmacovigilance,request.offering they 2022 2022
WithafirstdegreeinBiochemistry andPharmacologyandaPhDfocusing ondrugmetabolismand PharmacokineticsGraemehasworkedinthe areasofDrugSafetyandMedicalservicesfor over30 Graemeyears.hasbeenworkingasHeadofGlobal Pharmacovigilanceforamulti-nationalinnovator Company,andEUQPPVformanyofthetoptenPharma Companies,andsmall PharmaandhasbeenCEOforthe last19yearsforPharSafer®.
enhancedglobalpatientsafety,allwhileoperatingour QualityManagementSystemtoensurebothcompliance and Throughconsistency.ourjourney,overtime,wehaveacquired additionalexpertiseinadvisingandinformingourwiderangingclientbaseofthebestpossiblesolutionswithinan extremelycomplex,ever-expanding,andaglobalindustry whereregulationscontinuouslychange. Ourglobalexpertisecomesfromourhighlyskilledteamof Physicians,PhDs,MScscientists,andPharmacistswith manyyearsofexperienceinpharmacovigilanceand medicalservices.Weapplythisexperienceincollaboration withotherskilledmembersofourPharSafer®family–to notonlydeliverafirst-classserviceforourclientsbutto continuallyresearch,developandimplementinnovative processes,proceduresandproductsforthebenefitand advancementofthewiderindustry Weachievethis,workingtogetherwithoursistercompany –SaPharTraining®–PharSafer®trainsclientCompanies, runsbespoketrainingcoursesforlargeandsmallPharma, ensuresthehighesttrainingstandardsforPharSafer® personnel,andcontinuouslyseeksnewandinnovativeways toprovideaddedvalueforourclients,goingaboveand beyondexpectationsandoptimizingourmanydetailed processesandproceduresinvolvedwithclinicalandpostmarketingdrugsafetyandmedicalaffairs.
May
Whatarethecorevaluesuponwhichyourorganization isbuilt?Whatisthevisionandmissionofyour organization? Overall,ourmissionistokeepeachandeveryoneofour clientscompliantastheinternationalenvironmentevolves leadingthemthroughtheglobalmazethatisdrugsafety regulation,withexceptionalqualityofserviceforeveratthe forefrontofourthoughts. 2022
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Companies,companytoPharma,wayspostorganization evolvesourthe 2022 May 202239|www.insightscare.com
