Clinical Research Service Provider Information Form

Transcription

1 Clinical Research Service Provider Information Form General information Name of Organisation Vitalograph Ireland Ltd Contact information Head of Organisation Main contact Name: Frank Keane Address: Gort Road, Ennis, Co. Clare, Ireland Telephone: Fax: Web Site: Brochure (please attach if available): Attached Name: Jonathan Pritchard Address: Gort Road, Ennis, Co. Clare, Ireland Telephone: Fax: Does your organisation provide the following: Yes No Give details of experience Strategic Development Clinical Development plan Device Development plan (inc. design verification and validation) Diagnostic Development plan (inc. design verification and validation) Quality Management Vitalograph have a QMS with a full range of SOPs outlining how our equipment should be manufactured Page 1 of 5

2 and used within a clinical trials, Vitalograph s project management, device support and device manufacture services confirm with ISO13485:2003, ISO9001:2008, 21CFR 820 Risk Analysis Vitalograph perform a number of risk analysis steps during the development of a device or provision of services within a clinical trial. Risk is assessed that key points in a clinical study and strategies are implemented to mitigate or overcome risk where possible. These are outlined within the relevant SOPs Study Planning Vitalograph perform a comprehensive study plan during the provision of services within a clinical trial. The assigned project manager will create a project plan as well as delivering the services in timelines defined within the relevant SOPs Vendor Selection/Qualification When required Vitalograph have a in depth vendor selection and qualification strategy outlined within our SOPS Unitised costing model for services provided Can be provided on request Does your organisation have experience in Yes No Give details of experience the following study types: Observational Studies Health Surveys Clinical Trials on Investigational Medicinal Products (IMPs) Vitalograph provide equipment and support services to respiratory clinical trials in order to meet our Sponsor s needs. We have worked on over 40 clinical trials from phase I to IV in a number of countries around the world. Clinical Investigations on Medical Devices Clinical Studies on Diagnostics Biobanking Studies Vitalograph were involved in the UK Biobank study Page 2 of 5

3 Does your organisation provide the following: Yes No Give details of experience Project Provide consultation Management throughout all stages of the study process Identification of investigators/centres Protocol/CIP design: 1. Systematic review and meta-analysis 2. Methodology 3. Biostatistical design 4. Protocol/CIP writing Investigator Brochure Preparation Informed Consent Clinical trial services Regulatory Affairs/Ethics submissions Access to laboratory and preparation Project manager Medical monitoring Clinical research monitoring Qualified Person (QP) IMP batch release Qualified Person Pharmacovigilance (QPPV) Clinical Trial Applications phase I to IV for IMP Clinical Investigation Applications for medical devices Notification for Diagnostics Ethics Committee submission Central laboratory Core laboratory Page 3 of 5

4 clinical services Radiology ECG, BP monitoring etc. Other Respiratory data Over-reading services Medical writing Annual safety reports and reporting Clinical study reports Periodic Safety Update Report (PSUR) Biometrics Statistics Data management Provision of centralised data capture for provided spirometry/e-diary services allowing with study specific reporting services. ecrf/ CRFdesign Submissions Competent Authorities Notified Bodies FDA Other Reimbursement Pharmacoeconomics Health Technology Regulatory experience in therapeutic areas Assessments Cardiology Oncology Endocrinology Immunology Orthopaedics Neurology Psychiatry Infectious Diseases Dermatology Internal Medicine Paediatrics Interventional Radiology Page 4 of 5

5 Sensor Technologies Respiratory Abbreviations: IMP Investigational Medicinal Product CIP Clinical Investigation Plan BP Blood Pressure ECG Electrocardiogram ecrf Electronic Case Report Form CRF Case Report Form FDA Food and Drug Administration Page 5 of 5