Clintrials Skåne AB – from idea to marketSupporting all product development phases withinLife Science
ClinTrials Skåne AB• Contact between industry, academy and healthcare inRegion Skåne (southern Sweden).• Collecting information for product development (eg.decision support, market analysis, technical analysis).• Offers physical testing environments for the early phases ofproduct development and facilitates clinical trials for theadvanced phases.• Enters into all financial agreements concerning clinicaltrials for the Region Skåne.
Background• Clinical trials since 2009• Successful Vinnova project - Testbed in Skåne• Now fully integrated
Projects ClinTrials Skåne has assisted instarting1) Initial contact from the industry201447010203040501) Initial diskussion ClinTrials Skåne - näringsliv(totalt 81 förfrågningar)ClinTrials Skåne harbesvarat feasibilityförfråganpositivtClinTrials Skåne har tackatnej pga ointresse frånklinikerClinTrials Skåne har tackatnej efter diskussion medkliniker
Contracts signed by ClinTrials SkåneIncrease from 2011 to 2012: +12%.New pharma trials: +15%.861 234266119901020304050607080901002012 (totalt 140 st) 2011 (totalt 125)NyaläkemedelsprövningarTest av medicintekniskproduktFörlängning av studieroch amendmentÖvriga avtal
OverviewIndustryNeedsClinicsBiomedicalengineersSurgeonsNursesStatistical dataIT department
ServicesValidation of ideaInitial market analysis (X)Initial literature studyFirst idea, technology & prototype evaluationProject financial discussionEarly pre-clinicalphase (30-50h)(X) Possible parts: questionnaire, interview, analysis, initial plan and meeting with healthcare personnel.Market analysis(X)Literature studyAccess to patients and medical expertsInitial health economyAdd-on: Technical adaption to healthcareenvironmentsObservation studyLate pre-clinicalphase-I(100-200h)
ServicesGroup discussion patient/healthcare providersUsability & user-analysis – participationRisk analysis - participationTechnology & prototype evaluationAdd-on: Extended analysis (including healtheconomy, market analysis and literaturestudy).Late pre-clinical phase-II (250-300h)Planning of tests and clinical trialsFinancial assessmentFull health economy studyConcept validation – test in simulated clinicalenvironmentLate pre-clinical phase-III (300-400h)
ServicesProject quality assessment prior to clinical trialPlanning of clinical trialFeasibility-studyRecruitment of patientsClinical phase
Services• Clinical TrialsPhase-ITest offunction- on healthyindividualsPhase-IITest ofproductClinical trialwith a fewchosenpatients.Phase-IIITest for approvalClinical trial with manypatients (for CE-approval).
Available test environmentsIT-test bed- Access to Region Skånes IT envionmentVirtual Reality-labFor test of concept or similar .Clinical research unitE.g. clinical trials unit for phase 1 and 2,HTA, medical statistics. Full scale labFor assessments that require more space.Usability labFor usability analysis using advanced videorecording.Clinical practice lab (Practicum)Using simulation tools including advancedsimulated humans for product developmentand test.Developed testing environmentsUse of existing clinical testingenvironments: advanced home care andoperation room in use.Clinical environmentsAccess to the Region Skåne healthcaresystem.Regional equipmentAccess to the Region Skåne healthcareequipment.
Example: MRI-specialist• Company needed MRI-specialist input for a USprocurement.• Helped arrange meeting with MRI-specialist,biomedical engineer plus visit at MRI unit
Example: Healthcare market & needs• Investigate market potential and healthcareneeds for a new medical device• Study in a 2-step questionnaire/interview– 1st : Clinic selection– 2nd : Multitude of questions• Results: Healthcare needs, clinics, no. and typeof patients, technical specs, competition, etc.
Example: Observation study• Arrange observation study for large Frenchcompany• 24h observation team at cardiothoracic clinicPLUS• 2nd day interviews with selected personnel
Example: Medical device clinical trial• Preparing and arranging clinical trial of newmedical device• Help with dossier and form for ethical approval• Arranging suitable clinic and evaluation method• Report
Example: Camera-based alarm system• Acting as a knowledgeable partner in thedevelopment of new camera-based alarmsystems
PartnersInnovator Skåne ABRegion Skåne:Medical technology - Skåne University HospitalFoU-centrum SkånePracticum Clinical Skills CentreLunds University:Ergonomics and Aerosol technologyMedicine and Technology MSc educational programVidencenter for Innovation og Forskning – RegionH - DanmarkHandikapporganisationernas samarbetsorgan (HSO) Skåne
Goals• Fully functional and active clinical testbed.• Well-integrated and -known in the regional andnational Life Science industry.• Working structure of incentives for participatinghealthcare personnel and managements.• Increased levels of self financing