ITEC Services, French Contract Research Organization November 2016 - - PowerPoint PPT Presentation

FRANCE EUROPE NORTH AFRICA

ITEC Services, French Contract Research Organization

1

November 2016

December 18, 2016 2 www.itecservices.com

█ 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 █ Project Management █ Study Planning and Feasibility █ Site Selection and Support █ Site Monitoring █ Regulatory Affairs Management █ Data management █ Data analysis █ Medical writing █ Vigilance

What is a contract research

• rganization?

█ Profiles █ Project manager █ Regulatory affairs officer █ CRA █ Study coordinator █ Quality manager █ Data manager █ Biostatistician █ Medical writer █ Safety officer

December 18, 2016 3 www.itecservices.com

█ 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

Organization of the Company Ownership

December 18, 2016 4 www.itecservices.com

Organization of the Company Few figures

More than 30 years of expertise 55 employees More than 300 projects International coverage Repeat business > 80% Client satisfaction

Scope of Services

December 18, 2016 5 www.itecservices.com

Focus on early access projects

December 18, 2016 6 www.itecservices.com

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)

December 18, 2016 7 www.itecservices.com

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

December 18, 2016 8 www.itecservices.com

█ 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

Role of CRO within the supply chain during clinical trial conduct Subcontractors needs

December 18, 2016 9 www.itecservices.com

█ Clinical Packaging █ Clinical primary packaging █ Label design and printing █ Clinical labelling and secondary packaging █ Global Clinical Logistics █ Clinical distribution █ Cold chain management █ Depot network █ Return and destruction

Role of CRO within the supply chain during clinical trial conduct Subcontractors needs

• Good Manufacturing Practices
• Good Distribution Practices
• Inspections ANSM / ANSES
• Internal SOPs

December 18, 2016 10 www.itecservices.com

█ 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

Role of CRO within the supply chain during clinical trial conduct Early risk identification

December 18, 2016 11 www.itecservices.com

Role of CRO within the supply chain during clinical trial conduct Cooperation with subcontractors

CRO Clinical Supplies Partner Investigator sites

SPONSOR

Patient recruitment IMP reception and storage condition IMP requests management IMP issues management

December 18, 2016 12 www.itecservices.com

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

(to investigator sites)

Investigator sites SIV or Randomization CRO Clinical Supplies partner (CSP) Local depository

Email alert

• Request for IMP
• IPSO-IS
• Tracking on CTMS
• IPSO-LD
• IPSO-IS
• Tracking on

CSP software

• IPSO-IS
• Tracking on

CSP software AR IPSO-IS AR IPSO-LD Closely communication with CRA (product storage, shipment issues…)

Email alerts Upload IMP list with IMP number CTMS tracking

• IMP allocation
• deliveries
• receipts
• storage
• shipments, receipt of returns
• Product issues  quarantine

December 18, 2016 13

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

(to investigator sites)

Investigator sites CRO Clinical Supplies partner (CSP) Local depository

Email alert

• Request for IMP
• IPSO-IS emercengy
• IPSO-LD
• IPSO-IS
• Tracking on

CSP software

• IPSO-IS
• Tracking on

CSP software Deviation form Closely communication with CRA  identification of issues (temperature excursion)

Sponsor involvment  Decision on IMP usage

• If yes  site information 

STOP quarantine

• If not  site information 

MAINTAIN quarantine IMP quarantine

December 18, 2016 14

Role of CRO within the supply chain during clinical trial conduct Tools

December 18, 2016 15 www.itecservices.com

Organization of the Company Our contacts

Thierry DUBON Managing Director

• Tel. : +33 (0)5 57 77 85 00

thierry.dubon@itecservices.com Nathalie AUZERIE-DUBON CEO

• Tel. : +33 (0)5 57 77 85 00

nathalie.dubon@itecservices.com Mathieu CAPERAA International Business Developer

• Tel. : +33 (0)5 57 77 85 00

mathieu.caperaa@itecservices.com 32 years of expertise 50 employees More than 300 projects managed