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Cardialysis
Company Profile
Contents
Cardialysis overview
European Cardiovascular Research Institute (ECRI)
Clinical trial services
Complete suite of ...
Cardialysis profile
Cardialysis is a cardiovascular specialized full service Clinical Research Organization,
offering Core...
Cardialysis overview
Cardialysis services:
› Full-service Contract Research Organization (CRO)
› Strong academic global ca...
Track record
Broad cardiology experience
Cardialysis is currently involved in ~40* trials in various stages
Ranging from s...
Regular company audits
› On average 8 sponsor audits per year for:
› Compliance with ICH-GCP
› Compliance with ISO14155
› ...
CRO organisation chart
CEO
Human Resources
ICT
Operations &
Program Management
•Core Laboratory
•Statistics & Data
Managem...
Thought leader expertise
Patrick Serruys (Imperial College, London and
Emeritus Professor Erasmus MC, Rotterdam)
Stefan Wi...
Investigator network of >1400 sites
Europe: 1200 cardiovascular sites
9
Academic Research Consortium (ARC)
Harmonization of clinical endpoints
4 Academic Research Organizations (AROs) joining fo...
Vulnerable Patient Meeting (VPM)
Annual scientific meeting hosted by Cardialysis
Participation by invitation only; 75 – 10...
European Cardiovascular Research Institute
Platform for investigator initiated studies
ECRI is an organisational structure...
Full study life cycle
ARO
CRO & study platform
ARO for full trial life cycle
Medical Affairs
Cardialysis - CRO
Core Labora...
Services Overview
› Trial design and Protocol development
› Site feasibility and selection
› Site start-up, Regulatory sub...
European monitoring network
We have network of 70+ local monitors in 23 EU countries
Our monitoring network can easily be ...
Core Lab services
Supervising cardiologists
Supervision of Core Lab activities by experts in the field:
› Nicolas van Mieg...
Core Lab services
Independent and continuous focus on quality
› Techniques are validated to and in compliance with the lat...
Invasive modalities
High-quality output
› Invasive modalities: Angiography
› Quantitative Coronary Angiography (QCA)
› Syn...
Non-invasive modalities
High-quality output
› Echocardiography: CPA, 2D & 3D, TDI, TEE & TTE
› 12-lead ECG, Holter, implan...
Core Lab services
Track record
Since 1983, Cardialysis has provided Core Lab services for 150+ trials
including landmark t...
Clinical events adjudication
Save time and costs, easy to use
Clinical events adjudication at Cardialysis:
Large adjudicat...
Clinical events adjudication
Track record
Experience in clinical events adjudication services:
Total number of CEC activit...
Process overview
WebCEC
(internet)
add a
trigger
adjudic.
triggers
review
docs
add
request
Data
transfer
solve
queries
tra...
Tracking and checking of
triggers
› Potential sources of triggers
› Investigator-reported event triggers (e-CRF)
› Monitor...
Events Adjudication
Event trigger
WebCEC
Adjudication
Consistent
Adjudication
Inconsistent
Adjudication
Final
Face-to-face...
Web reporting and database
› Reporting:
› WebCEC includes reporting tool with pre-defined status reports
› Report data in ...
Track record
Selection of current trials I
Transaortic valve implantation
2500 patients, global
Services: protocol, CEC ad...
Track record
Selection of current trials II
Evaluation of NOAC in Patients after Successful Transcatheter Aortic Valve Imp...
Track record
Landmark clinical trials I
ABSORB (Abbott, bioresorbable scaffold)
Serruys, Lancet 2009;373:897-910
30 patien...
Track record
Landmark clinical trials II
COMPARE I and II (WESPH, drug-eluting stent)
Kedhi, Lancet. 2010 Jan 16;375(9710)...
Track record
Landmark clinical trials III
IBIS-2 (GSK, darapladib)
Serruys, Circulation 2008;118:1172-82
330 patients, 25 ...
Track record
Landmark clinical trials IV
PURSUIT (Schering-Plough, eptifibatide)
Harrington, NEJM 1998;339:436-43
12,500 p...
Track record
Landmark clinical trials V
SYNTAX (Boston Scientific, stent and CABG)
Serruys, NEJM 2009;360:961-72
3075 pati...
› Specialized in cardiovascular trials for >33 years (300+ in recent 20 years)
› ECRI Faculty advisory network for trial d...
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Cardialysis company profile

Cardialysis is a leading specialist clinical research organization (CRO) with an exclusive focus on cardiology, providing a full range of clinical research and cardiovascular core laboratory services. Founded in 1983, Cardialysis is recognized for its opinion-leader expertise, strong academic network and in-depth cardiology expertise and in recent years has significantly expanded its operational activities. The world’s top medical device, biotechnology and pharmaceutical companies collaborate with Cardialysis resulting in more than 300 clinical trials (in the recent 20 years) conducted up till now, contributing to improved cardiovascular therapies.

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Cardialysis company profile

  1. 1. Cardialysis Company Profile
  2. 2. Contents Cardialysis overview European Cardiovascular Research Institute (ECRI) Clinical trial services Complete suite of services Independent Core Laboratory experience Clinical event adjudication experience Selection of current clinical trials Track record Summary 2
  3. 3. Cardialysis profile Cardialysis is a cardiovascular specialized full service Clinical Research Organization, offering Core Laboratory services and Academic Clinical Research services. Based in Rotterdam, the Netherlands Founded in 1983 as spin-off from Thoraxcenter of the Erasmus Medical Centre Started as holter monitoring organization - cardiovascular expertise Specialist in cardiovascular clinical trials: 300+ trials (recent 20 years) Phase I / FIM – Collaboration with Erasmus MC experimental cardiology Phase II – III / CE-marking / IDE / PMDA Post-marketing trials & registries Investigator-Initiated studies via ECRI Compliant with FDA / EMA / Japanese GCP / ICH guidelines & ISO 14155 3
  4. 4. Cardialysis overview Cardialysis services: › Full-service Contract Research Organization (CRO) › Strong academic global cardiology network › Fully integrated imaging Core Laboratory › DSMB and CEC services › Experience in supporting submission to competent authorities › Sponsor capability through ECRI Global reach – European focus with ability to conduct global clinical trials Staff – 120+ in-house staff and 70 local monitors Opinion-leader expertise and strong academic network – KOLs / PIs / sites Expertise – In-house subject matter expertise in cardiovascular area domain 4 Therapeutic focus: coronary artery disease atherosclerosis heart failure electrophysiology structural heart disease stroke prevention hypertension peripheral artery disease
  5. 5. Track record Broad cardiology experience Cardialysis is currently involved in ~40* trials in various stages Ranging from start-up to finalization Cardialysis has managed >300 trials 75 Pharma trials 200 Device trials 25 Investigator-Initiated Studies Data of >100 trials have been used for Competent Authorities in US, EU and Japan Data of >50 trials have been submitted for gaining CEmark Experience with DEKRA, TÜV & BSI *From full-service to single-service trials (e.g. Core Lab or statistical analysis) 5
  6. 6. Regular company audits › On average 8 sponsor audits per year for: › Compliance with ICH-GCP › Compliance with ISO14155 › European regulatory requirements › FDA regulatory requirements 6
  7. 7. CRO organisation chart CEO Human Resources ICT Operations & Program Management •Core Laboratory •Statistics & Data Management Quality Assurance Secretariat CFO Facility Services Finance & Control Project Strategy & Business Development CRA Department •CRA/CTA •Safety reporting •Site management Project Management Research & Business Development Business Development Medical Affairs Board of Management Cardialysis has more 120+ employees located in Rotterdam and 70+ freelancers located in 23 countries in Europe
  8. 8. Thought leader expertise Patrick Serruys (Imperial College, London and Emeritus Professor Erasmus MC, Rotterdam) Stefan Windecker (Bern University; Bern) Robert-Jan van Geuns (Erasmus MC; Rotterdam) Gabriel Steg (Bichat-Claude Bernard Hospital Center; Paris) Marco Valgimigli (Inselspital Universitätsspital; Bern) Nicolas van Mieghem (Erasmus MC; Rotterdam) Arie-Pieter Kappetein (Erasmus MC; Rotterdam) Freek Verheugt (Onze Lieve Vrouwe Gasthuis; Amsterdam) Jan Tijssen (Academic Medical Centre Amsterdam) 8
  9. 9. Investigator network of >1400 sites Europe: 1200 cardiovascular sites 9
  10. 10. Academic Research Consortium (ARC) Harmonization of clinical endpoints 4 Academic Research Organizations (AROs) joining forces: Boston Harvard Clinical Research Institute Durham Duke Clinical Research Institute New York Cardiovascular Research Foundation Rotterdam Cardialysis Cooperating with the FDA , clinicians and relevant clinical societies Completed: ARC I & II (Coronary stenting) VARC I & II (TAVR) BARC (Bleeding) PARC (Peripheral Intervention) Initiatives: NARC (Non adherence) VARC III (TAVR) Neurological ARC (neurological endpoints) 10
  11. 11. Vulnerable Patient Meeting (VPM) Annual scientific meeting hosted by Cardialysis Participation by invitation only; 75 – 100 attendees Faculty of thought leaders, regulators, industry experts & decision makers Expert in-depth discussion regarding vulnerable patients Updates on the progress of technologies Scientific Board of Directors Patrick W. Serruys - Imperial College London, UK Gregg W. Stone - Columbia University Medical Center, USA Wolfgang Koenig - Ulm University, Germany Amir Lerman - Mayo Clinic, USA Ton van der Steen - Erasmus MC, The Netherlands James Muller - USA 11
  12. 12. European Cardiovascular Research Institute Platform for investigator initiated studies ECRI is an organisational structure that: › acts as intermediate between thought leaders and supporting industries › acts as sponsor for investigator initiated studies › controls the clinical research projects › has no intention of making profit Current ECRI trials: ECRI initiatives: ECRI 1 – GLOBAL LEADERS COMPARE ABSORB ECRI 2 – SYNTAX II TAVR UNLOAD ECRI 3 – ABSORB STEMI; the TROFI II study ENTRUST ECRI 4 – SYNTAX III Revolution GALILEO ECRI 5 – DESSOLVE III ECRI 6 – GALILEO 4D ECRI 7 – TALENT ECRI 8 – MASTER DAPT ECRI 9 – TAVR UNLOAD IMAGING SUBSTUDY 12
  13. 13. Full study life cycle ARO CRO & study platform ARO for full trial life cycle Medical Affairs Cardialysis - CRO Core Laboratory & CEC Statistics & DSMB Clinical & Statistical methodology Scientific & Clinical Community Trial Design / Conduct Site Network GCP compliance Full-service study execution Site Management ECRI – academic platform Study Design Patient Pathway Study Oversight & Budget Control Presentations & publications Safety Reporting Data Management
  14. 14. Services Overview › Trial design and Protocol development › Site feasibility and selection › Site start-up, Regulatory submission & contracting › Clinical monitoring and Site management › Project management › eCRF development & Data management › Safety monitoring and reporting › Statistical analysis and reporting › Clinical Event Committee (CEC) Adjudication Services › Data and Safety Monitoring Board (DSMB) › Cardiovascular Core Laboratory
  15. 15. European monitoring network We have network of 70+ local monitors in 23 EU countries Our monitoring network can easily be increased depending on sponsor requirements. All local monitors are trained and work according to the Cardialysis SOP’s. The BeNeLux countries are monitored by our in-house CRA’s. 15
  16. 16. Core Lab services Supervising cardiologists Supervision of Core Lab activities by experts in the field: › Nicolas van Mieghem Imaging of cardiac valves › Folkert ten Cate Echocardiography › Arend Schinkel Echocardiography › Joost Daemen Coronary angiography › Maarten Witsenburg Electrocardiography › Rohit Bagwandien Electrocardiography › Eugene McFadden Event adjudication Cardialysis in-house supervising cardiologists: › Dr Osama Soliman Consultant cardiologist specialized in non-invasive cardiovascular imaging. Serves on the editorial board of the Journal of the American Society of Echocardiography. › Dr Yoshinobu Onuma Consultant interventional cardiologist specialized in intra-coronary imaging. Leading expert in the field of bioresorbable scaffolds. › Dr. Ernest Spitzer Consultant cardiologist with focus on Heart Failure, Event Adjudication oversight, Safety review 16
  17. 17. Core Lab services Independent and continuous focus on quality › Techniques are validated to and in compliance with the latest regulatory and industry standards › ISO 14155: 2011 (GCP) › GCLP endorsed by WHO: 2009 › FDA 21 CFR part 11: electronic records, electronic signature › Test runs and training of sites › Feedback to sites on quality of images / recordings › E-transfer of images possible if required (AGMednet) › Continuous training of Core Lab analysts › Less than 5% turnover in Core Lab staff › High-quality data with minimum inter- and intra-observer variability › Quality assurance and quality control › Reproducibility protocols including phantom analysis 17
  18. 18. Invasive modalities High-quality output › Invasive modalities: Angiography › Quantitative Coronary Angiography (QCA) › Syntax Score (Qualitative Angiography) › Bifurcation Analysis › LV Analysis › Quantitative Vessel Analysis (QVA) › Invasive modalities: Sound-based modalities › Intravascular Ultrasound (IVUS, gray scale) › Virtual Histology (VH, Volcano) › iMap (Boston Scientific) › IVUS Palpography › Invasive modalities: Light-based modalities › Optical Coherence Tomography (OCT) › Near-Infrared Spectroscopy (NIR) 18
  19. 19. Non-invasive modalities High-quality output › Echocardiography: CPA, 2D & 3D, TDI, TEE & TTE › 12-lead ECG, Holter, implantable loop recorder and ECG event monitoring › Exercise tolerance test: treadmill and stress echo › Cardiac Magnetic Resonance Imaging (MRI) › Multi-Slice Computed Tomography (MSCT) 19
  20. 20. Core Lab services Track record Since 1983, Cardialysis has provided Core Lab services for 150+ trials including landmark trials, such as BENESTENT, SYNTAX, LEADERS, GLOBAL LEADERS, ABSORB-STEMI and EUROPA Non-invasive Core Lab Cardialysis has extensive experience: Successfully completed >1 million data sets of non-invasive imaging modalities including ECGs, ambulatory monitoring tracings, device ECG, ECHO, MRI and MSCT in trials, such as ECHO IRIS, ADVANCE, PROTECT, SOFA, RESPOND, MORE CRT-MPP, RESPOND LOTUS and HORRACLES Invasive Core Lab Cardialysis has extensive experience: Successfully completed >1 million data sets of intravascular imaging modalities including QCA, IVUS, VH and OCT in trials, such as BENESTENT, RAVEL, LEADERS, ABSORB II, RESOLUTE, FANTOM II, COMPARE ABSORB and IBIS II 20
  21. 21. Clinical events adjudication Save time and costs, easy to use Clinical events adjudication at Cardialysis: Large adjudicator network Fully trained in Cardialysis procedures Highly configurable web-based system Adjudication according to FDA and EMA Guidelines and ARC initiatives Advantages for sponsor Secure web-based environment Swift appointment of highly experienced event committee members 100% detection of suspected events Smooth and quick clinical event adjudication processes and workflow Harmonization and consistency of source document review Access to DICOM files for review during adjudication 21
  22. 22. Clinical events adjudication Track record Experience in clinical events adjudication services: Total number of CEC activities: 100+ trials Current number of CEC activities: 25 trials Largest trial: ~7000 event triggers Experience with in-house platform: ~70000 event triggers Global, with emphasis on Europe 22
  23. 23. Process overview WebCEC (internet) add a trigger adjudic. triggers review docs add request Data transfer solve queries transfer data Document handling trigger to CEC source docs complete adjudic. package handle CEC request Receipt & Scan monitor contacte-CRF image scan › Complex process; strict rules required › Subdivision in 4 phases: › Trigger & document receipt and digitizing › Preparation of triggers/documents; assign to CEC members › Review of documents & adjudication by CEC members › Data transfer to Sponsor data transfer
  24. 24. Tracking and checking of triggers › Potential sources of triggers › Investigator-reported event triggers (e-CRF) › Monitor-detected under-reported event triggers › eCRF-derived programmable event triggers › Core lab-derived event triggers › CEC-generated event e-mail alert e-CRF Cardialysis Trigger list (daily update) WebCEC Queries Other sources
  25. 25. Events Adjudication Event trigger WebCEC Adjudication Consistent Adjudication Inconsistent Adjudication Final Face-to-face meeting or teleconference Adjudication by consensus Data entered by the Chair Final Consensus meeting
  26. 26. Web reporting and database › Reporting: › WebCEC includes reporting tool with pre-defined status reports › Report data in WebCEC can be exported › Database: › Completely validated, and 21 CRF part 11 compliant › Audit trail › Modular approach › Authorization with User ID, password AND token › Application (interface) and data are separate
  27. 27. Track record Selection of current trials I Transaortic valve implantation 2500 patients, global Services: protocol, CEC adjudication and DSMB Hybride surgical ablation 210 patients, Europe Services: regulatory submission, monitoring, data management, safety reporting and statistical reporting Bioresorbable scaffold 501 patients, global Services: Core Lab (OCT, IVUS, MSCT and QCA) and CEC adjudication PCI and DAPT 16,000 patients, global Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab Evaluation of TAVR and optimal Heart Failure Therapy versus OHFT in HF patients 600 patients, USA, Europe and Canada Services: protocol, statistics, monitoring EU, CEC adjudication, DSMB, safety reporting EU and Core Lab (ECG) Coronary Artery Disease - Cardiotonic Agent 3000 patients, global 27
  28. 28. Track record Selection of current trials II Evaluation of NOAC in Patients after Successful Transcatheter Aortic Valve Implantation 1500 patients, Europe and US Full service Heart failure: CRT-D 3796 patients, global Services: Core Lab (LVEF ECHO, X-ray lead and ECG) Left atrial appendage occlusion 700 patients, Europe Services: CEC adjudication Transaortic valve implantation 1000 patients, global Services: Core Lab (TAVI ECHO) Bioresorbable Scaffold 190 patients, Europe Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab PCI in three-vessel disease (3VD) 450 patients, Europe Services: protocol, statistics, data management, monitoring, CEC adjudication, DSMB and Core Lab 28
  29. 29. Track record Landmark clinical trials I ABSORB (Abbott, bioresorbable scaffold) Serruys, Lancet 2009;373:897-910 30 patients, 5 sites Europe and New Zealand Services: design, Core Lab (QCA, IVUS, VH & OCT) and CEC adjudication ABSORB Cohort B (Abbott, bioresorbable scaffold) Ormiston, Lancet 2008; 371: 899–907 Serruys, Lancet 2009; 373: 897–910 101 patients, 10 sites Europe and New Zealand Services: Core Lab (IVUS, VH, OCT, MSCT, Palpography and QCA) APPROACH (GSK, rosiglitazone) Gerstein, Circulation 2010;121:1176-87 672 patients, 92 sites, 19 countries in Europe, US, Asia and South America Services: Core Lab (IVUS) BENESTENT (J&J, coronary stent) Serruys, NEJM 1994;331:489-95 520 patients, 28 sites, 9 countries in Europe and South America Services: design, data management, statistics, Core Lab: QCA, CEC adjudication, monitoring and coordination 29
  30. 30. Track record Landmark clinical trials II COMPARE I and II (WESPH, drug-eluting stent) Kedhi, Lancet. 2010 Jan 16;375(9710):201-9 Smits, Lancet. 2013 23;381(9867):651-60 Total : 4500 patients in Europe Services: statistics, CEC adjudication and Core Lab (Syntax Score) EUROPA (Servier, perindopril) Fox, Lancet 2003;362:1-7 13,200 patients, 450 sites, 25 EU countries Services: design, data management, statistics and Core Lab (IVUS sub-study) EXAMINATION (Abbott, bare metal stent and drug-eluting stent) Sabate, JACC Cardiovasc Interv. 2014 Jan;7(1):55-63 2665 patients, 5 sites in Italy and Spain Services: statistics, CRF, data management, CEC adjudication, DSMB and monitoring HELVETICA (Ciba Geigy, hirudin) Serruys, NEJM 1995;333:757-63 1141 patients, 28 sites, 7 countries in Europe Services: design, Core Lab (QCA), CEC adjudication and statistics 30
  31. 31. Track record Landmark clinical trials III IBIS-2 (GSK, darapladib) Serruys, Circulation 2008;118:1172-82 330 patients, 25 sites, 10 countries in Europe Services: Core Lab (IVUS, VH and palpography) LEADERS (Biosensors, drug-eluting stent) Windecker, Lancet 2008;372:1163–73 1707 patients, 10 sites in Europe Services: design, data management, Core Lab (QCA and Syntax Score), CEC adjudication and statistics LIPS (Novartis, fluvastatine) Serruys, JAMA 2002;287:3215-22 1677 patients, 77 sites, 10 countries Services: design, data management and statistics PROSPECT - Palpography sub study (Abbott, stent) Stone, N Engl J Med. 2011 20; 364(3):226-35 350 patients, 40 sites in US and Europe Services: Core Lab (Palpography) 31
  32. 32. Track record Landmark clinical trials IV PURSUIT (Schering-Plough, eptifibatide) Harrington, NEJM 1998;339:436-43 12,500 patients, 351 sites, 18 countries US, Europe and South America Services: data management and CEC adjudication RAVEL (Cordis, drug-eluting stent) Morice, NEJM 2002;346:1173-80 238 patients, 19 sites, 7 countries in Europe and South America Services: design, data management, Core Lab (QCA), CEC adjudication & statistics RESOLUTE (Medtronic, drug-eluting stent) Serruys, N Engl J Med 2010; 363:136-462 300 patients, 79 sites in Europe Services: protocol, statistics, data management, CEC adjudication and Core Lab (ECG and QCA) SOFA (WCSF, fish oil) Brouwer, JAMA 2006;295:2613-19 500 patients, 25 sites in Europe Services: data management, monitoring and Core Lab (ICD and ECG) 32
  33. 33. Track record Landmark clinical trials V SYNTAX (Boston Scientific, stent and CABG) Serruys, NEJM 2009;360:961-72 3075 patients, 86 sites US and Europe Services: design, Core Lab (QCA and Syntax Score), CEC adjudication and monitoring TWENTE I and II (Dutch Peers, drug-eluting stent) Von Birgelen, Lancet. 2014 1; 383(9915):413-23 Von Birgelen, J Am Coll Cardiol. 2012 10; 59(15):1350-61 3200 patients, 1000 sites Global Services: CEC adjudication 33
  34. 34. › Specialized in cardiovascular trials for >33 years (300+ in recent 20 years) › ECRI Faculty advisory network for trial design in cardiology › Efficient integrated cardiovascular Core Lab and web-based CEC system › Global reach, covering EU, US, South America and Australasia › One point of contact and full CRO services › Master Service Agreements with: › AtriCure Inc, Abbott Vascular, Boston Scientific, Medtronic and St Jude Medical › Flexible, sponsor-focused approach to meet your trial objectives 34 Summary

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