Corporate Presentation. October 2017

Transcription

1 Corporate Presentation October 2017

2 Company Overview OPIS is an international CRO providing: - A wide range of clinical and e-clinical services for Pharmaceutical and Biotechnology Industries, Medical Device companies as well as Academic Institutions and Non-Profit organizations - International and Local Phase I-IV studies - Observational studies and IITs Founded by medical doctors from the Pharma Industry Qualified, fully trained and dedicated staff 20 years of experience Expertise in main therapeutic areas 26m in sales +250 people Commitment to quality: 179 audits/ 7 inspections More than 1000 studies managed 10 locations all over Europe

3 Organisation CEO Medical Department Medical Writing Logistics Clinical Solutions/ Business Development Strategic Advice Trial Start-up & Regulatory Pharmacovigilance Documentation Clinical Operations Quality Management General Affairs Scientific Advice Biometrics Department Systems Management Data Management SAS programming Statistics Finance Legal and Compliance Quality & Information Security ICT Human Resources IT service System Analysis & Programming

4 Locations and International Structure Trial Leader OPIS Sweden Country Project Managers OPIS Belgium OPIS UK OPIS Poland Local Submission Specialists CRAs (employees & freelancers) OPIS Germany OPIS France OPIS Switzerland OPIS Italy OPIS Romania OPIS Spain Trial Leader coordinates international activities Fully operating subsidiary Presence of monitors

5 OPIS Services at a glance Medical Writing and Scientific Advice Regulatory and Clinical Operations Site selection Trial Start-up Project Management Monitoring Quality Management Study Data Document management Data management Statistics E-clinical suite (EDC platform) Pharmacovigilance Project Control Training

6 Medical Writing A qualified team of medical writing experts and medical doctors produce and edit: Full range of regulatory and clinical documentation Across all therapeutic areas and across all clinical research phases In short timeframes Stand-alone or part of full service

7 Regulatory and Clinical Operations Regulatory and Start-up Preliminary site assessment (Investigators database in various indications) Feasibility checks Site Selection Adaptation of documents to local requirements Contract negotiations Regulatory and EC submissions Project Management Staff Training & Management Coordination and Supervision of Monitoring Activities Planning & Tracking patient recruitment Ensuring proper management of all study related data Ensuring streamlined communication among parties Project execution in compliance with all applicable requirements Acting as SPoC for Sponsors Monitoring Site visits according to Monitoring Plan Remote monitoring, if required Site support between visits Issue management and escalation, if applicable

8 Quality Management Check of documentation for submission (Trial Start-Up) Check of study documentation (Trial Master File) Random check of monitoring reports; alternatively complete check of monitoring reports of the center under evaluation (e.g. in preparation of audits) Co-monitoring (tutoring and site compliance visits) Site audit/inspection preparation Training sessions Further quality services (e.g. centralized management and distribution of SOPs) or checks upon request (e.g. specific documentation such as training docs, financial disclosure forms, CVs)

9 Study Data Handling Integral - high quality - reliable - analyzable DATA Biometry Data Management Biostatistics SAS Programmers CRF design Clinical.net In-house developed 10 years experience Extendible & customizable Validated EDC ICH/GCP guidelines Protocol specifications CDISC standards ecrf implemetation FDA 21 CFR Part 11 compliant Modular, web-based technology

10 Clinical.NET Study Web Portal Fully customizable and configurable Modules can operate as standalone services or integrated into the CLINICAL.NET Study Portal with secure access through a single access point GCP and FDA 21 CFR Part 11 compliant

11 Pharmacovigilance Integrated Drug Safety Assurance Safety monitoring and reporting during clinical ph I-III Post Marketing Surveillance Local QPPVs Eudravigilance-certified staff Flexible suite of pharmacovigilance and safety monitoring as stand-alone or part of full service package

12 Project Control All activities strictly monitored Objectives Ensure that contractual timelines and requirements are met Provide extrapolation and data query tools for reporting to the Sponsor, e.g. supplying exports, reports, periodic status updates, as required Identify potential interfaces with Sponsor s systems Facilitate information sharing

13 Clinical Investigations for Medical Devices Quality assistance towards market access Regulatory expertise Qualified and certified resources Quality management CRF / ecrf development Post market d support Fully compliant data elaboration processes Project control UNI EN ISO compliant trials

14 Trial Distribution/phase Experience based on more than 1000 trials 40,4% 27,6% 11,0% 7,7% 9,7% I II III IV OBS MED DEVICE/OTHER 3,6%

15 6,4% 6,1% 5,4% 5,0% 4,6% 4,2% 4,0% 2,8% 2,4% Therapeutic Areas 27,9% 17,1% 14,2% OTHER: Gastroenterology, Musculoskeletal, Genetic Diseases, Infections and Infectious Diseases, Psychiatry/Psychology, Vaccines, Urology, Gynecology, Nephrology, Dental and Oral Health, Endocrinology

16 Audits and Inspections Due diligence FCCA System ISO Site Inspections (Privacy, AIFA, EMA) Finance

17 Best practice We believe in Trust Transparency Professionality Reliability People Collaboration Partnerships Teams Technology Development Growth Innovation Efficient work Timelines SPoC Streamlined processes Planned Hours Specific Safety at work Mandatory Total OPIS invests in training

18 Sponsor Collaborations Big Pharma Biotech/Mid-size Pharma Academic/Non-profit Organisations Medical Device Cosmeceuticals Nutraceutics

19 THANK YOU «It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change» Charles Darwin Headquarters OPIS s.r.l. Palazzo Aliprandi - Via Matteotti, Desio (MB) Italy - P office@opis.it - website: