World class academic leadership for your clinical trials

Transcription

1 World class academic leadership for your clinical trials

2 Clinical Sites 1-45 Countries >150,000 Patients Enrolled

3 What is C5Research? C5Research is an academic research organization (ARO) which provides clinical research services to the biotechnology, medical device and pharmaceutical industries, as well as providing support for Cleveland Clinic investigator-initiated research trials. We bring clinical and academic expertise to research. We strive to promote innovation and to impact the clinical care of patients through the dissemination of trial results in top-tier journals, at scientific meetings and through education in our premier teaching hospital. We provide comprehensive, academically oriented planning, coordination, and management of multicenter clinical trials. We provide independent oversight of clinical trial committees (Executive, Steering and Data Monitoring). We facilitate efficient start-up and operation of clinical trials with the goal of publishing results that will have a major impact on the medical care of patients. Our Mission: To design and conduct innovative clinical research that enhances scientific knowledge about the treatment of diseases and improves medical care of patients.

4 What is C5Research to Sponsors? We are a non-profit organization dedicated to helping sponsors successfully collect relevant efficacy and safety data within agreed upon timelines, with the highest standards, complying with FDA regulations, and satisfying the demanding peer-reviewed scrutiny of the academic and scientific community. We bring world class academic leadership to clinical trials and customize our services to meet trial needs. Our Expertise For over a decade, C5Research has combined scientific and clinical leadership in cardiovascular disease with operational excellence in Phase II-IV multicenter, clinical trial coordination. This strong foundation in cardiovascular trial coordination has been expanded to include other therapeutic areas, capitalizing on the academic, scientific and medical expertise of Cleveland Clinic. When choosing C5Research, a sponsor can expect independent, accurate and detailed investigations that are respected in the academic and scientific communities, will strongly influence the care of patients, and will provide credibility and shorter time-to-market in the product development cycle. Detailed trial descriptions can be found on our website at:

5 Why Work With C5Research? We have expertise in a variety of therapeutic areas that is recognized worldwide. Cleveland Clinic Heart and Vascular Institute has been ranked the #1 program for cardiac care in the US for over a decade by US News and World Report, and Cleveland Clinic ranks among the top 5 hospitals overall. We have access to the expertise of leading scientists and physicians in all branches of medicine within Cleveland Clinic. We have provided scientific leadership in the conduct of clinical trials from small, single-center Phase II trials to large, global, multi-center Phases III and IV trials. Our physicians have served on FDA regulatory panels and thus have insight into agency thinking. We disseminate results quickly at national and international meetings and in top-tier journals. Complexity of Clinical trials A clinical trial requires expertise in the areas of Project Management, Data Management, Site Management, Core Laboratories, Regulatory / Safety, Randomization, Statistics, and Drug/ Device Supply. We have worked with a broad spectrum of different research organizations, including Contract Research Organizations (CROs) and other AROs, in the various aspects of trial conduct. We coordinate with all parties involved in a trial to minimize overlap and duplication of effort by determining who is best suited for each task. We believe partnering, shared responsibility and communication are the keys to success.

6 C5Research Physician Leadership A. Michael Lincoff, MD, Director of the Center for Clinical Research and Vice Chairman for Clinical Research of the Lerner Research Institute is also the C5Research Director and provides clinical trial leadership. In addition, Stephen J. Nicholls, MD, PhD, is Cardiovascular Director of C5Research and provides clinical trial leadership. There are seven Associate Directors, physicians with expertise in cardiovascular sub-specialties, additional Core Lab Directors and access to over 500 Cleveland Clinic physician experts in all areas of medicine, located on the campus of Cleveland Clinic. Steven E. Nissen, MD, is Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at Cleveland Clinic and former C5Research Director. Overview We are an academic group led by Marlene Goormastic, MPH, C5Research Director of Operations, that believes in doing the highest quality work following International Conference on Harmonization/Good Clinical Practice guidelines. We bring an independent, academic viewpoint that provides study credibility for the academic and scientific community. We provide world class academic leadership for your clinical trials by having a Cleveland Clinic physician lead the trial as the head of the Steering or Executive Committee. The academic lead is a physician who is both experienced in the conduct of clinical trials and who has expertise in the disease area under investigation. Our ultimate objective is to bridge our basic and translational scientific expertise to bring new therapies from the laboratory bench to the bedside. Many other physicians within the Cleveland Clinic collaborate and support C5Research The C5Research team works closely with the trial academic leadership to develop and finalize a study protocol that is both feasible and answers an important medical question. We assist with site selection and management. We organize and manage the clinical trial committees (Executive, Steering and Data Monitoring). The C5Research academic lead contributes his/ her expertise in meetings with the FDA, peer-topeer interactions at investigator meetings and presentation of trial results at major medical conferences. The benefit in working with an Academic Research Organization (ARO) cannot be overemphasized in an era of public and government wariness and increased scrutiny in trial conduct and results. The top journals require the authors to provide a statement of independent data access and validation of trial results. As an ARO, we require the complete trial dataset after database lock, and we validate the primary and secondary results before publication.

7 We have Core Labs that provide high quality and timely imaging analysis. We have an adjudication process that provides highly reliable and timely adjudication of clinical events. We collaborate with the Sponsor, often working with a Contract Research Organization (CRO) or other AROs to assure that all services required are done in the most efficient manner by the organization best equipped to provide that service. We facilitate efficient start-up and operation of clinical trials with the goal of publishing results in top tier medical journal that will have a major impact on the practice of medicine. Partnerships C5Research has collaborated with over 60 device and pharmaceutical companies during the past two decades, as diverse as small start-ups to Fortune 500 corporations. We develop a customized model of operational and communication requirements with each partnership. Often these models include CRO and/or ARO partners. This unique blend of C5Research, the sponsor, CRO and/or ARO provides an effective and efficient means to manage clinical studies and meet pre-specified timelines. Sponsors may find additional information on our website at:

8 C5Research Services Project and Site Management Core Laboratories Clinical Data Management Statistics Contracts and Finance Regulatory and Quality Assurance Project and Site Management Project leadership and coordination Physician, project manager and research coordinator expertise to enhance protocol development, implementation and trial conduct Site database and site selection Clinical resources for study sites including 24 hour clinical on-call service CRO / Sponsor liaison Site and Monitor education Enrollment and Communication expertise Steering Committee and Data Safety Monitoring Committee selection / management

9 Clinical Events Committee (CEC) The Clinical Events Committee Core Lab provides blinded, unbiased, expert adjudication of endpoint events. Endpoints adjudicated include Death Myocardial infarction Stroke Revascularization Bleeding (TIMI, GUSTO, CURE, and other definitions) Hospitalizations for acute coronary syndrome Hospitalizations for heart failure Peripheral vascular events Gastroenterological events

10 Imaging Core Laboratories Our imaging core laboratories provide unbiased interpretation of imaging examinations for device and pharmacologic clinical studies while decreasing inter-observer variability and increasing accuracy and precision. We establish and oversee compliance of imaging protocols and guidelines and interact with sites on an ongoing basis to maintain quality of images. We provide standardized image acquisition training to investigators to ensure consistent high quality imaging across all enrolling centers. In addition, our analysis processes incorporate quality control and assurance methods throughout the course of each study.

11 Our imaging core laboratories provide unbiased interpretation of imaging examinations for device and pharmacologic clinical studies while decreasing inter-observer variability and increasing accuracy and precision

12 Atherosclerosis Imaging Core Laboratory Angiography More than 20,000 angiographic films analyzed in over 50 clinical studies International experience in the US, Canada, Europe, South America and Asia Trial experience includes CAVEAT, TAMI-9, EPIC, EPISTENT, APEX-AMI, CATSCAN and IMPACT-II to name a few. Analysis provided for clinical trials in: Thrombolytic therapies Percutaneous Intervention (PCI) New coronary devices Interventions with concomitant drug therapy Progression / Regression LV function Angiographic assessments include: Quantitative Coronary and Vascular Angiography (QCA & QVA) TIMI grade TIMI frame count (ctfc) Myocardial Perfusion / blush (TMP) AHA/ACC lesion morphology assessments Left-ventricular ejection fraction (LVEF) Thrombus assessments

13 Intravascular Ultrasound (IVUS) More than 12,000 ultrasound imaging exams have been completed in over 20 clinical studies. International experience in the US, Canada, Europe, South America and Australia Trial experience includes REVERSAL, NORMALISE, ACTIVATE, ASTEROID, Apo A1 Milano, ILLUSTRATE and PERISCOPE. Analysis provided for clinical trials in: Atheroma Progression/Regression Coronary and Vascular Percutaneous Intervention (PCI) Transplant Vasculopathy IVUS assessments include: Volumetric analysis Restenosis analysis Plaque characterization assessment Carotid Intimal Medial Thickness (CIMT) Core Laboratory Initiated in 2006, the CIMT Core Lab has completed several projects ranging from 20 to more than 200 subjects. Trial experience includes PPAR and several internal studies. The CIMT Core Lab measures the thickness of the two inner layers of the carotid arteries with non-invasive ultrasound to predict risk of cardiovascular events.

14 Cardiovascular Imaging Core Laboratory Echocardiography Initiated in 1996, the Echo Core Lab has completed over 40 clinical studies and analyzed more than 20,000 echocardiograms. International experience in the US, Canada, Europe, Central America and Asia Trial experience includes VECTOR, RETHINQ, PREMIER, Perimount FenPhen, Fen-Phen and the ACUTE studies. Analysis provided for clinical trials in: Electrophysiology devices Heart failure/heart transplantation Intra-operative trials involving ventricular assist devices Aortic atheroma Prosthetic valves Valve repair/replacement Neurology, oncology and hypertension studies Echo assessments include: Left ventricular mass and function Wall motion scoring and analysis Transpulmonary echo contrast grading and analysis Atrial Fibrillation

15 Nuclear Cardiology The Nuclear Cardiology Core Laboratory at the Cleveland Clinic Heart and Vascular Institute analyzes Nuclear image data collected as part of clinical trials. Our physicians at Cleveland Clinic: are recognized nationally and internationally as leaders in their fields; are qualified to quantitatively analyze nuclear research exams; use a consistent set of definitions required to perform nuclear image analysis. Nuclear exams are analyzed using American Society of Nuclear Cardiology (ASNC) guidelines and standards as well as core lab standard operating procedures (SOPs). Cardiac Computed Tomography and Magnetic Resonance Imaging The Nuclear Core Lab has experience in providing analysis for clinical trials since Our nuclear experience includes SPECT, PET and MUGA modalities with image volume between 32 and 5000 exams per modality. Modality specific protocols are developed and customized for each trial. These protocols are also used to instruct the collaborating centers on the minimum imaging requirements for subjects enrolled in the trial. The Nuclear Core Lab has dedicated resources for processing, analyzing, transferring and storing image data associated with clinical trials. Initiated in 2006, the CT/MR core facilities can assess: Myocardial ischemia Improved characterization of myocardial function Coronary artery assessment (e.g., plaque-load determination) Response of the failing left ventricle to various interventions Pre-cardiac-surgery planning Arterial-wall imaging

16 Peripheral Vascular Core Laboratory Initiated in 1996, the PV Core Lab has completed over 10 studies and analyzed data for more than 2,500 subjects with typical study durations of 5 years. Trial experience includes Zenith, ENACT, SECURITY and Excluder. Analysis provided for clinical trials in: Abdominal and Thoracic Aortic Aneurysm devices Peripheral devices Carotid devices Imaging modalities reviewed include: Computed Tomography (CT) Magnetic Resonance Imaging (MR) Angiography X-ray Ultrasound (Duplex and IVUS) Assessments include: Centerline vessel analysis Volume measurements 3D/volume rendering Curved Planar Reformatting 4D analysis of cardiac gated studies Vascular stenosis, thrombosis, and calcification Detailed device integrity

17 Biomarker Core Laboratory An array of clinically validated mass spectometry assays is also available A CAP and CLIA Reference Lab measures a full suite of traditional laboratory diagnostics (both chemistry and immunodiagnostics), multiple novel markers of inflammation and cardiovascular risk that predict heart disease. An array of clinically validated mass spectrometry assays is also available. Assay development and/or validation for applying research grade assays to large scale clinical studies is available.

18 Clinical Data Management CDM provides data management services primarily for Core Labs. These services include implementation of standardized processes, development of standardized data forms, frequent communication / interaction with the Core Labs resulting in quick resolution of queries, and scheduled data transfers of cleaned / locked cases to sponsor and/or CRO. Statistics We provide trial design and sample size determination, protocol review, review and input into the statistical analysis plan (SAP), review and input on case report forms and edit checks, independent validation of trial results and statistical support for manuscripts and scientific presentations (primary and post study).

19 Contracts and Finance Our Contracts and Finance team facilitates confidentiality agreements with investigators / sites; handles third party contracts and payment including Data Monitoring Committee (DMC) / Steering Committee, Clinical Events Committee reviewers, meeting planners and other trial participants; facilitates sponsor / site contract negotiation and management, manages and administers site payments including detailed tracking and reporting to sponsor; and administrative accounting for each clinical study. Regulatory and Quality Assurance Regulatory and Quality Assurance for C5Research are provided by Compliance Specialists experienced with the regulatory requirements of both the Sponsor and Investigator. Regulatory and Quality Assurance offers the following services: Independent Auditing Good Clinical Practice (GCP) Training The Regulatory and Quality Assurance team provides C5Research with regulatory consultation and a comprehensive, multifaceted Quality Assurance Program. Independent auditing services are also available and provided to Sponsors. The primary goal of the Regulatory and Quality Assurance team is to promote data integrity and protection of human subjects by ensuring compliance with Federal Regulations, GCPs, and sponsoring agencies policies and procedures governing the use of human participants in research.

20 C5Research Cleveland Clinic JJ Euclid Avenue Cleveland, OH Tim Crowe Project Development Tel: Fax: Revised 9/2010