Clinical Research Service Provider Information Form

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1 Clinical Research Service Provider Information Form General information Name of Organisation Real Regulatory Limited Contact information Head of Organisation: Main contact Name: Derval OCarroll Address: Unit 9A Plato Business Park, Damastown, Dublin 15, Ireland Telephone: Fax: docarroll@realregulatory.ie Web Site: Brochure (please attach if available): Name: Derval OCarroll Address: Unit 9A Plato Business Park, Damastown, Dublin 15, Ireland Telephone: Fax: docarroll@realregulatory.ie Does your organisation provide the following: Yes No Give details of experience Strategic Clinical Development plan Real Regulatory Limited (RRL) provide regulatory Development Device Development plan input including quality, non clinical and clinical with a (inc. design verification and validation) Diagnostic Development plan (inc. design verification and validation) team to support the overall regulatory aspects of the development process. Examples include preparing and guiding Sponsors through Scientific advice from national Competent Authorities and European Medicines Agency (EMA) in various therapeutic areas. Preparation and submission of Orphan Drug Applications and Paediatric Investigation Plans (PIPs). Due diligence exercises on behalf of Page 1 of 6

2 Page 2 of 6 Sponsors and/or investors on the regulatory readiness of development plans and clinical data. Preparation and submission of Clinical Trial Applications for all phases of clinical trial into more than 29 countries in Eastern and Western Europe. Activities include writing IMPDs, project management of regulatory activities input to decisions on substantial amendments etc (More detailed metrics can be provided on a project specific basis). Preparation of position papers to Notified Bodies to support medical device clinical strategy in support of CE marking; preparation and submission of Clinical Investigation Applications to Competent Authorities. preparation of Clinical Evaluation Reports per the current MEDDEV guidance and in compliance with the Medical Device Directive. Provision of experienced clinical and non clinical experts to support KOLs in understanding the regulatory environment and expectations for regulatory submissions. (Please note I have not included details of RRL post marketing experience in regulatory activities such as variations as this is not directly related to the clinical trial arena but please feel free to ask for more details). Quality Management RRL team includes device experts who are qualified as lead auditors and are experienced in setting up and preparing companies for certification to ISO9001:2008 and ISO and GMP. (One of our team has previous worked at the Notified Body NSAI). We have particular experience in the combination medical device arena in assisting

3 companies prepare for inspections and regulatory submissions. RRL is certified to ISO 9001:2008 Risk Analysis Yes, for medical devices per ISO 14971:2007 (including training) For pharma yes for benefit risk analysis document for CTA Study Planning Vendor Selection/Qualification Unitised costing model for services provided Does your organisation have experience in Yes No Give details of experience the following study types: Observational Studies From a regulatory perspective there are similar Health Surveys principles applied to submissions. For IMPs we have Clinical Trials on Investigational Medicinal experience of preparing and making regulatory Products (IMPs) Clinical Investigations on Medical Devices submissions for all phases of studies and hands on experience of project management of regulatory Clinical Studies on Diagnostics aspects of ongoing studies. See above for Biobanking Studies experience. Metrics can be provided on a project specific basis. For medical devices and IVDs we have experience of preparing strategy documents, discussions with Notified Bodies and Competent Authorities and preparation of submission documents. Does your organisation provide the following: Yes No Give details of experience Project Management Provide consultation throughout all stages of the study process Please see items above. RRL has a team based over two offices in Dublin and London plus a network of regulatory consultants based in European countries (Eastern & Western) and a panel of quality, non clinical and clinical experts to support. A team is pulled together on a project specific basis to provide Page 3 of 6

4 Clinical trial services Regulatory Affairs/Ethics submissions Access to laboratory and clinical services 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 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 Radiology ECG, BP monitoring etc. Other the relevant therapeutic expertise. Page 4 of 6

5 Medical writing Annual safety reports and reporting Clinical study reports Periodic Safety Update Report (PSUR) Biometrics Statistics Data management ecrf/ CRFdesign Submissions Competent Authorities Notified Bodies FDA Other Reimbursement Pharmacoeconomics Health Technology Assessments Regulatory Cardiology experience in Oncology therapeutic areas Endocrinology Immunology Orthopaedics Neurology Psychiatry Infectious Diseases Dermatology Internal Medicine Paediatrics Interventional Radiology Sensor Technologies Other Antibacterial; GI ; Gynaecology; Ophthalmology Page 5 of 6

6 Abbreviations: IMP CIP BP ECG ecrf CRF FDA Investigational Medicinal Product Clinical Investigation Plan Blood Pressure Electrocardiogram Electronic Case Report Form Case Report Form Food and Drug Administration Page 6 of 6

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