ClinTrials Skåne AB

Fred Kjellson, Senior Project Manager

Clintrials Skåne AB – from idea to market

Supporting all product development phases within Life Science

ClinTrials Skåne AB

• Contact between industry, academy and healthcare in Region Skåne (southern Sweden).

• Collecting information for product development (eg. decision support, market analysis, technical analysis).

• Offers physical testing environments for the early phases of product development and facilitates clinical trials for the advanced phases.

• Enters into all financial agreements concerning clinical trials for the Region Skåne.

Background

• Clinical trials since 2009

• Successful Vinnova project - Testbed in Skåne

• Now fully integrated

Projects ClinTrials Skåne has assisted in starting 1) Initial contact from the industry

2014

47

0

10

20

30

40

50

1) Initial diskussion ClinTrials Skåne - näringsliv(totalt 81 förfrågningar)

ClinTrials Skåne harbesvarat feasibilityförfråganpositivt

ClinTrials Skåne har tackatnej pga ointresse frånkliniker

ClinTrials Skåne har tackatnej efter diskussion medkliniker

Contracts signed by ClinTrials Skåne

Increase from 2011 to 2012: +12%.New pharma trials: +15%.

86

1 2

3426

611

99

0102030405060708090

100

2012 (totalt 140 st) 2011 (totalt 125)

NyaläkemedelsprövningarTest av medicintekniskproduktFörlängning av studieroch amendmentÖvriga avtal

Overview

Industry

Needs

Clinics

Biomedicalengineers

Surgeons

Nurses

Statistical data

IT department

Services

Validation of ideaInitial market analysis (X)Initial literature studyFirst idea, technology & prototype evaluationProject financial discussion

Early pre-clinical phase (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 healthcare

environmentsObservation study

Late pre-clinical phase-I

(100-200h)

Services

Group discussion patient/healthcare providersUsability & user-analysis – participationRisk analysis - participationTechnology & prototype evaluationAdd-on: Extended analysis (including health

economy, market analysis and literature study).

Late pre-clinical phase-II (250-300h)

Planning of tests and clinical trials Financial assessmentFull health economy studyConcept validation – test in simulated clinical environment

Late pre-clinical phase-III (300-400h)

Services

Project quality assessment prior to clinical trialPlanning of clinical trial Feasibility-studyRecruitment of patients

Clinical phase

Services

• Clinical TrialsPhase-ITest of function- on healthy individuals

Phase-IITest of productClinical trial with a few chosen patients.

Phase-IIITest for approvalClinical trial with many patients (for CE-approval).

Available test environments

IT-test bed- Access to Region Skånes IT envionment

Virtual Reality-labFor test of concept or similar .

Clinical research unitE.g. clinical trials unit for phase 1 and 2, HTA, medical statistics. Full scale lab

For assessments that require more space.

Usability labFor usability analysis using advanced video recording.

Clinical practice lab (Practicum)Using simulation tools including advanced simulated humans for product development and test.

Developed testing environmentsUse of existing clinical testing environments: advanced home care and operation room in use.

Clinical environmentsAccess to the Region Skåne healthcare system.

Regional equipmentAccess to the Region Skåne healthcare equipment.

Example: MRI-specialist

• Company needed MRI-specialist input for a US procurement.

• Helped arrange meeting with MRI-specialist, biomedical engineer plus visit at MRI unit

Example: Healthcare market & needs

• Investigate market potential and healthcare needs 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 type of patients, technical specs, competition, etc.

Example: Observation study

• Arrange observation study for large French company

• 24h observation team at cardiothoracic clinicPLUS • 2nd day interviews with selected personnel

Example: Medical device clinical trial

• Preparing and arranging clinical trial of new medical 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 the development of new camera-based alarm systems

Partners

Innovator Skåne ABRegion Skåne:

Medical technology - Skåne University HospitalFoU-centrum SkånePracticum Clinical Skills Centre

Lunds University:Ergonomics and Aerosol technologyMedicine and Technology MSc educational program

Videncenter for Innovation og Forskning – RegionH - DanmarkHandikapporganisationernas samarbetsorgan (HSO) Skåne

Goals

• Fully functional and active clinical testbed.

• Well-integrated and -known in the regional and national Life Science industry.

• Working structure of incentives for participating healthcare personnel and managements.

• Increased levels of self financing

CEOUlf MalmqvistTel:0769-42 74 82ulf.malmqvist@clintrialsskane.se

Trials coordinatorGertrud LundkvistTel: 046 -17 33 56Gertrud.lundkvist@clintrialsskane.se

Project managerFred KjellsonTel: 0766 - 48 60 76fred.kjellson@clintrialsskane.se

Market analyst/financingAnna ChristersonTel. 0709 – 22 87 24Anna.christerson@clintrialsskane.se

Biomedical engineerMaisa WardaTel. 046-17 10 83Maisa.warda@skane.se

Biomedical engineerBengt EksundTel. 040 - 33 35 56Bengt.eksund@skane.se

PRMagdalena TaylorTel. 046-17 31 17Magdalena.taylor@skane.se

Contact