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Oncology Study SupportDelivering Oncology Studiesfor Over 25 Yearssimbecorion.com
More than 25 years delivering oncology studies from phase I-IVsimbecorion.comBringing deepunderstandingOur experience conducting Phase I/II adaptive oncology clinicaltrials, through to Phase III rescue studies has given us a deepunderstanding of managing complex hospital-based studies,supported by a world-leading oncology advisory board.Our goal is the same as yours: to improve patients’ lives. Patientrecruitment and retention are key, and at the heart of this isour patient-centric approach. We understand that for somepatients, the decision to participate in an early-stage clinicaltrial, especially in oncology, can be challenging. We strive fora personal approach to ensure patients feel supported andengaged throughout the study.23Simbec-OrionOncology Study Support
simbecorion.comWhat we offerPhase I-IV servicesWe deliver the full range of clinical developmentservices you would expect from a large CRO, with thestructure and size to offer personalised, tailor-madesolutions. Delivering a integrated and responsiveapproach to mitigate risk and smooth the path toyour next milestone.An international, full-service clinical researchorganisation specialising in oncology studiesProject ManagementRegulatory AffairsConsulting &Strategic SupportClinical MonitoringCentral LaboratoryIMP ManagementMedical &PharmacovigilanceBiometrics (DataManagement & Statistics)Technical WritingPK/PD StudiesBioavailability &Bioequivalence StudiesBioanalytical LaboratoryScintigraphyScientific AdvisoryBoard (SAB)Head office situated in the UK, with localoffices in France, the USA and Hungary.45Simbec-OrionOncology Study Support
The right-sized CRO, with international reachsimbecorion.comServicesYour international team3%5%Experienced CRAs, CTLs,CTAs & PMs21%7%Bionanalyitcal, clinicalpathology & IMP capabilityWith four main offices inthe UK, Europe, and theUSA, as well as operationalteams more widely locatedthroughout Europe and NorthAmerica, we have the globalreach to deliver studies inevery region and acrossmultiple timezones.Support disciplines:- Biometrics- Regulatory affairs- Medical & technical writing- Pharmacovigilance12%33%Our morethan 400employeesinclude:39%20%13%13%28%6%Scientific advisory board withexpertise in oncology studiesThe Simbec-Orion ScientificAdvisory Board (SAB) is establishedto offer our clients additionalsupport and guidance in our coretherapeutic areas of oncology,including rare oncology.The SAB consists of experts in theirrespective fields with extensiveexperience in:- Clinical development- Scientific consultancy- Complex protocol designAuthorisation- MarketingApplications by both theEMA and the FDA67Simbec-OrionOncology Study Support
Caring ambitiouslyCaring ambitiously is one of our fivecore values. We make a difference topeople’s lives - through the work wedo and the way we do it. We make apositive impact on drug developmentfor our clients and - most importantly- their patients.89Simbec-OrionOncology Study Support
In-house oncology clinicaldevelopment expertssimbecorion.comOncology drug developmentrequires flexibility anddetermination at studysites with close studymanagement guidanceWe understand the importance of the rightpartnerships to ensure a seamless oncology study– not just with our clients, but with key referenceoncology sites in Europe and the USA.Simbec-Orion has established relationships withinvestigative sites and KOLs in oncology, which allowsus to customise our approach and deliver both onyour program and corporate objectives with expeditedtimelines. By keeping sites engaged throughoutthe study and providing tailored training and studysupport, we can ensure participating sites continue tostay motivated for the study duration. In addition, ourScientific Advisory Board is always on hand to supportand has specialist experience in oncology.1011Simbec-OrionOncology Study Support
Agility and resiliencesimbecorion.comWe endeavour toprovide a personalservice for all ourprojects, offeringbespoke solutionsthat are the rightfit for our clientsOur size and low hierarchy management structuremakes for agile, flexible processes – ideal for highlytailored, complex protocols and early-phase oncologystudies. It allows us to rapidly respond to challengesor escalate issues quickly when required. Whetherfor issue escalation or advice mid-way through yourproject, our senior team is always on hand to offersupport, because your success is our success.Our teams are supported by best-in-class systemsand our additional services ensure you have a robustsupporting framework for your study.1213Simbec-OrionOncology Study Support
Oncology specialistssimbecorion.comWe understand the complexities and challengesfaced in oncology studies and have the rightnetwork to support your studyExperts in modular oncologytrial design.Experienced across multiple classes ofproduct including: NCEs – small moleculesand biologics, cell therapy, vaccines,antisense and gene therapy.Supported by world renownedScientific Advisory Board withoncology expertise.As well as our established links with oncologycentres across North America and Europe, ourrelationship with the Oncodistinct Networkgrants us access to additional cancer centresand university hospitals.Established relationships with opinionleading oncology clinicians, from bothNorth America and Europe.1415Simbec-OrionOncology Study Support
Oncology experiencesimbecorion.comPercentage of studiesby tumour typeOur experiencedefines our expertiseSarcoma (2%)LymphomaFor more than 25 years, the scientists atSimbec-Orion have managed clinical trialsover an extensive range of tumour types, andwith all classes of product including, newchemical entities (NCEs) – small molecules,biologics (antibodies, peptides), cell therapy(genetically modified organisms -GMOs),vaccines, antisense and gene therapy.5%Leukemia10%44%Other / AdvancedSolid TumorBy tapping into this experience, we cansupport your goals helping you to drive yourdevelopment program forward.Carcinoma39%As oncology experts, Simbec-Orion has vast oncology study experience across manytumour types, including rare cancers.We hold specialist expertise in the rare oncology space with 25% of our rare diseaseexperience in rare oncology indications.1617Simbec-OrionOncology Study Support
Our valuesWe are defined by ourfive core values and arecommitted to makingSimbec-Orion a greatplace to work by buildingon these values to shapeour company culture.simbecorion.comCaringambitiouslyA tight-knitteamWe make a difference to people’slives - through the work we do andthe way we do it. We make a positiveimpact on drug development forour clients and - most importantly their patients.We become an extension of yourteam, dedicated to your clinicaldevelopment - whatever thechallenges.Dedicatedto deliveryForwardthinkingRadicallyhonestWe reference our values during ourhiring and on-boarding processes.In this way, we are confident thatwe are recruiting like-mindedindividuals with values that alignwith ours.By attracting the right talent to joina team already proud to work forSimbec-Orion, we strive to continueto make a difference. Both to theway we work, and to the lives ofthe patients waiting for newand improved therapies aroundthe world.No matter what the problem. Or howbig the challenge. Our dedicationto delivery for you and ultimatelypatients, drives us every timewithout exception.18We’re an agile team, willing and ableto adapt to continuously changingcircumstances.Ethics and compliance are at theheart of what we do. So integrityis everything. We work withtransparency, because that’s thehonest thing to do.19Simbec-OrionOncology Study Support
Key case studysimbecorion.comMetastatic breast cancerSolutionPhase III rescue study: resolving siteissues through CRO collaboration andon-site training.An open-label, randomized, parallel, two-arm,multicenter, international Phase III study in patientswith recurrent or metastatic breast cancer previouslytreated with cytotoxic chemotherapy regimens.A sponsor that had previously worked with SimbecOrion invited us to re-monitor a percentage of workbeing conducted by a mega CRO on their phase IIIbreast cancer study. The sponsor was questioningwhy they were not seeing a normal level of backgroundnoise in the study (particularly protocol deviations) andwanted us to help investigate.Study objectivesreview the active study sites and the- Tomonitoringpractices and conduct of theexisting CRAs.ChallengesA collaborative approach to CRA training and retrospective re-auditing of sites.Due to the size of the study, the sponsor wanted tocontinue the relationship with the mega CRO butwanted Simbec-Orion to work alongside them toresolve the issues identified.Senior, highly experienced CRAs worked alongside existing monitorsThis required a tactful approach which relied on honestcommunication and teamwork from all parties.Our CRAs attended sites alongside the existing site monitors, resulting in re-monitoring extended in selectedareas. Re-monitoring of tumour assessment data for a percentage of patients was requested and the highestrecruiting site was judged to require 100% re-monitoring.Our initial review confirmed thatthere were substantial issues withone of the sites, especially with thelevel of source data verification.Dedicated time to develop a relationship and rapport across teamsWe were asked to examine moresites and review the RECISTassessment of tumours. We foundthat there were errors in the datacollected, with potential problemsacross one-third of sites.Retrospective re-audit and re-SDV of all information from problem siteOne site was highlighted by thesponsor as a potential fraudconcern as data was constantlychanging between visits.identify any issues with the conduct of the- Tostudy,including data collection and reporting,and report back to the sponsor.in partnership with the sponsor- Toandworkexisting CRO to rectify past issues andWe developed a mentoring strategy to train junior CRAs from the other CRO. Senior CRA’s from Simbec-Orionshared guidance and experience, which was well received and improved performance.To accelerate timelines, we were able to organise the sample preparation under special conditions, preciselycoordinating the time-critical delivery to our central laboratory.OutcomeSimbec-Orion’s high-quality monitoring by our experienced CRAs ensured thatthis large phase III study provided high quality, publishable data to support thefurther development of the drug.Once additional attention was applied the study, it proceeded positively tocompletion and the sponsor was pleased with all parties’ involvement.Our collaborative approach and expertise helped the sponsor get the projectback to original timelines, leading to a successful study after the rescue period,with all parties satisfied.ensure the project remained within the initalprojected timelines, and that high-quality,accurate data was obtained.2021Simbec-OrionOncology Study Support
Over 25 years delivering oncology from phase I-IVsimbecorion.comWe are here to help withthe next step of yourclinical developmentSimbec-Orion is a responsive and agilefull-service CRO, with wide therapeuticexperience and specialist expertise inclinical pharmacology, oncology and rarediseases. Perfectly structured, we providefull-service clinical development solutionsfor small and mid-size drug developers –headed up by a centralised leadership team.With a focus on tailor made and scalablesolutions, we’ll adapt our delivery style,communications and operations to suitthe demands of your project, helpingyou achieve your clinical and commercialobjectives. Because our goal is the same asyours; to improve patients’ lives.Find out more at www.simbecorion.com orcontact us at y Study Support
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As oncology experts, Simbec-Orion has vast oncology study experience across many tumour types, including rare cancers. We hold specialist expertise in the rare oncology space with 25% of our rare disease experience in rare oncology indications. For more than 25 years, the scientists at Simbec-Orion have managed clinical trials
