ITEC Services, French Contract Research Organization November 2016 1 FRANCE EUROPE NORTH AFRICA
What is a contract research organization? █ Definition A CRO is an organization contracted by another company to manage and lead the company's trials, duties and functions █ Mission Contract research organizations (CROs) provide clinical trial and other research support services for the pharmaceutical, biotechnology, medical device industries and also serve government institutions, foundations and universities █ █ Services Profiles █ █ Project Management Project manager █ █ Study Planning and Feasibility Regulatory affairs officer █ Site Selection and Support █ CRA █ █ Site Monitoring Study coordinator █ █ Regulatory Affairs Management Quality manager █ █ Data management Data manager █ █ Data analysis Biostatistician █ Medical writing █ Medical writer █ █ Vigilance Safety officer 2 www.itecservices.com December 18, 2016
Organization of the Company Ownership █ A France based CRO, since 1984 █ A privately owned, medically driven full service CRO. █ Ownership: Nathalie AUZERIE-DUBON, CEO. █ The main objectives of ITEC Services is to conduct national and worldwide clinical trials and post authorisation studies for pharmaceutical, biotechnological and medical device companies. █ Main activities: study management, regulatory management, center selection and data monitoring, vigilance, data management, statistics, medical writing. █ Experience in various therapeutic areas . █ Our main Quality objectives are: █ Protection of patient data participating to our clinical trials, █ To ensure that clinical trials are conducted and data are generated, recorded and reported in compliance with the protocol, GCP, GEP, and applicable regulatory requirements. █ Certified ISO 9001 since 1997 and our organization complies with the ISO 27001 3 www.itecservices.com December 18, 2016
Organization of the Company Few figures More than 30 years of expertise Repeat business > 55 80% employees Client satisfaction International More than coverage 300 projects 4 www.itecservices.com December 18, 2016
Scope of Services 5 www.itecservices.com December 18, 2016
Focus on early access projects Global solution or Acting according to the sponsor Request for Proposal █ ATU (Temporary Authorisation For Use) █ Protocol for therapeutic use █ Dedicated Data base development █ Receipt of data collection forms, validation with the sites in real time █ Validation of inclusions and allocation of inclusion numbers █ Management of products orders █ Pharmacovigilance and periodic reports █ RTU (Recommendation for Temporary Use) █ Dedicated Data base development █ Development of automatisms for the organization of the data flow between the different stakeholders: workflows, e-mail alerts, reminders █ Provision of a hotline for health care professionals █ EAP (Early Acess Program) 6 www.itecservices.com December 18, 2016
Organization of the Company International coverage International studies are covered through native speaking CRAs/monitors in every participating country. Project management and other central services remain with our experienced staff at our office. Example of countries involved in our study France, Spain, UK, Germany, Italy, Poland, Belgium, Netherlands, Hungary, Slovakia, United States, Canada █ Focus on international involvment █ Management of France for international project Corporate sponsors █ Management of International studies (full services) French sponsors 7 www.itecservices.com December 18, 2016
Role of CRO within the supply chain during clinical trial conduct Subcontractors needs █ Depending on type of clinical trials █ National █ International █ Study design (management of therapeutic units, central labs) █ Randomization █ Blinded / unblinded █ Depending on type of study drugs █ Temperature control █ Cold chain █ Product stability █ Product repackaging on investigator sites 8 www.itecservices.com December 18, 2016
Role of CRO within the supply chain during clinical trial conduct Subcontractors needs █ Clinical Packaging - Good Manufacturing Practices █ Clinical primary packaging - Good Distribution Practices █ Label design and printing - Inspections ANSM / ANSES █ Clinical labelling and secondary packaging - Internal SOPs █ Global Clinical Logistics █ Clinical distribution █ Cold chain management █ Depot network █ Return and destruction 9 www.itecservices.com December 18, 2016
Role of CRO within the supply chain during clinical trial conduct Early risk identification █ Our missions █ Protection of patient data participating to our clinical trials, █ To ensure that clinical trials are conducted and data are generated, recorded and reported in compliance with the protocol, GCP, GEP, and applicable regulatory requirements █ Organization and workflow with the subcontractor █ Communication █ Clinical packaging process, customized patient kit, timing █ Clinical logistics process, workflow, timing, traceability (deliveries, receipts, storage, shipments, pick-up and receipt of returns), management of issues █ Organization and workflow with the investigator site █ Communication with CRA █ Follow up of patient recruitment █ Follow up of product distribution and issues 10 www.itecservices.com December 18, 2016
Role of CRO within the supply chain during clinical trial conduct Cooperation with subcontractors SPONSOR Clinical Investigator Supplies CRO sites Partner Patient IMP requests recruitment management IMP reception IMP issues and storage management condition 11 www.itecservices.com December 18, 2016
Role of CRO within the supply chain during clinical trial conduct General workflow - IMP: Investigational Medicinal Product - IPSO-LD: Investigational Shipment Order (to local depository) - IPSO-IS: Investigational Shipment Order Investigator (to investigator sites) - IPSO-IS sites - Tracking on CSP software Closely communication with CRA (product SIV or Local storage, shipment depository Randomization issues…) AR IPSO-IS AR IPSO-LD Email alert - IPSO-LD - IPSO-IS - Tracking on Email alerts CSP software Upload IMP list with IMP number CTMS tracking Clinical - IMP allocation - deliveries Supplies CRO - receipts partner (CSP) - storage - shipments, receipt of returns - Request for IMP Product issues quarantine - - IPSO-IS - Tracking on CTMS 12 www.itecservices.com December 18, 2016
Role of CRO within the supply chain during clinical trial conduct Temperature excursion - IMP: Investigational Medicinal Product - IPSO-LD: Investigational Shipment Order (to local depository) - IPSO-IS: Investigational Shipment Order Investigator (to investigator sites) - IPSO-IS sites - Tracking on CSP software Closely communication with CRA Local identification of depository issues Deviation (temperature IMP form excursion) quarantine Email alert - IPSO-LD - IPSO-IS - Tracking on CSP software Sponsor involvment Decision on Clinical IMP usage Supplies If yes site information - CRO STOP quarantine partner If not site information - (CSP) MAINTAIN quarantine - Request for IMP - IPSO-IS emercengy 13 December 18, 2016
Role of CRO within the supply chain during clinical trial conduct Tools 14 December 18, 2016
Organization of the Company Our contacts Nathalie AUZERIE-DUBON CEO Tel. : +33 (0)5 57 77 85 00 32 years of expertise nathalie.dubon@itecservices.com Thierry DUBON Managing Director 50 employees Tel. : +33 (0)5 57 77 85 00 thierry.dubon@itecservices.com More than Mathieu CAPERAA 300 projects managed International Business Developer Tel. : +33 (0)5 57 77 85 00 mathieu.caperaa@itecservices.com 15 www.itecservices.com December 18, 2016
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