CDI CENTRO DIAGNOSTICO ITALIANO and its CENTRAL ...

CDI CENTRO DIAGNOSTICO ITALIANOand its CENTRAL LABORATORYYear 2012

CDI CENTRO DIAGNOSTICO ITALIANO and itsCENTRAL LABORATORYCDI Centro Diagnostico Italiano is a division of the Bracco Group and has beenactive in Milan for the past 35 years as a full service out-patient health care facilitymainly focused on prevention, diagnosisi and therapy in a“day hospital” environment.It offers a wide range of services including a diagnostic area, accredited by the ItalianNational Health Service (SSN) for what concerns laboratory tests, diagnosticimaging, nuclear medicine and radiotherapy, and an area for private patients as wellas for companies.Since we firmly believe in quality, we have developed our own "Quality System"which is certified, since 1997, according to ISO 9001:2008 standards.CDI is accredited by Joint Commission International since 2006.1

2CDI has 20 operativee units within the territory of Milan, including blood samplingsites, ambulatories, day service facilities and the Central Laboratory situated atheadquarters. CDI employs over 800 people including medical specialists, healthtechnicians, nurses and other professionals who are at the service of approximately600,000 patients per year.The Laboratory is established over a total area of 1,400 square meters andprovides over 500 different types of analysis which are, for the most part, performedat headquarters. Every day, in the blood sampling sites, up to 2,200200 patients t areserviced, corresponding to more than 4 million tests performed every year.Clinical safety datamanagement,processtraceability and constantanalytical quality controlguide the daily activities ofthe highly specializedCentral Laboratory of theCDI.2

3Cutting-edge scientific equipment and instruments allow CDI to meet Clientneeds promptly and reliably. They are characterized by a strong integration ofrobotics and computer science such as, the clinical chemistry, immunochemistry andhaematology automated chains; at the CDI laboratory, primary test tubes identifiedwith barcode labels are placed directly on the instrument and the analyses areperformed without any manipulation by the operator.The CDI Central Laboratory is organized into 9 specialized divisions:Clinical ChemistryHaematologyMicrobiologyOncologic, Infective & Postnatal GeneticsPathological AnatomySerologySerum Protein ElectrophoresisToxicologyUrines and Autoimmunity3

4The CDI CENTRAL LABORATORY plays anIMPORTANT ROLE in CLINICAL TRIALSSince 1994, the CDI Laboratory is also specialized in performing phase I, II, III andIV Clinicali l Ti Trials, acting both nationally and internationally ti (Europe and Russia), forpharmaceutical companies, CROs and other public or private research centres.CDI utilizes modern technologies, specialized staff and is committed to the higheststandards of quality through continued investments, aimed to increase accuracy andprecision of the clinical studies.Believing in innovation has thus constantly proven to be a winning choice: CDIdemonstrates every day how constant improvement is part of its corporate policy,and this is fueled everyday by motivated and detail-oriented professionals.In this context, the CDI Laboratory organization is based on practices inspired byinternationally recognized standards, such as those of the British MHRA (Medicinesand Healthcare products Regulatory Agency), the U.S. FDA (Food and DrugAdministration) and the European Commission (Enterprise and IndustryDirectorate-General - Pharmaceuticals).Recently, Centro Diagnostico Italiano has been officially recognized by the LocalHealth Agency (LHA) as a qualified Central Laboratory to carry out analyses onbiological samples, supporting phase I, II, III and IV Clinical Trials of medicinesperformed both on patients and on healthy volunteers.CDI is a member of the Clinical Trials Register of Private Laboratories, and islisted on the Italian Medicine Agency (AIFA) website, which is a public source ofinformation about clinical trials with medicines conducted in Italy, reporting also theregulations and ethical principles ruling research throughout the national territory.4

6Unique to Italy and Europe, CDI’s Genetic Section has 4 Ikoniscopes now, whichare powerful automated systems for the detection and the analysis of FISH images(Fluorescence In Situ Hybridization) of histological and cytological slides; Ikoniscopeis able to detect tumor cells and/or the presence of genetic alterations (ALK, EGFR,Her2-neu) with a 100 % sensitivity.Ikoniscope is also a viable technique for evaluating and detailing circulating tumorcells (CTCs) in the blood. This new method of detection is undoubtedly advancingthe practice of medicine and shows great promise in the ability to provide moreaccurate information to develop the best treatment plan possible.CDI’s Pathological Anatomy Section,which avails itself of a Second Opinionservice led by Dr. Juan Rosai, provideshistological examinations with a highquality centralized validation.6

7The proteomics avails itself of sophisticated technologies that allow current clinicalissues to be approached with the greatest effectiveness.The use of the ISAC System (ImmunoSolid-phase Allergen Chip) consents tosearch simultaneously, using a single dose,in triplicate on a microchip, specific IgEsagainst 103 allergenic recombinant proteins.CDI’s mission is to work for the constant pursuit of quality service and technicalexcellence. It is committed to meeting client expectations based on the flexibility andcollaboration of its team.The CDI Central Laboratory is able to customize its service and to adapt it to thespecific clinical protocol in order to combine maximum safety and data reliability atthe lowest possible cost. It is able to implement new tests on demand and thetechnical accredited solutions are always shared with the Client before the trial.For what concerns logistics, CDI avails itself of a dedicated Transport Company asa reliable and specialized partner for delivering critical and sensitive shipments.Dedicated solutions for every requirement, maintenance of any type of transporttemperature, e, real time monitoring of any shipment, minimum delivery e times andgreat operational flexibility, represent only some of the main points that allows CDI toguarantee the quality of every single managed operation.Estimates are detailed in the interest of full transparency for the Client. Qualitycontrol is constantly performed on all phases of the process, from the initial stagesof the contract to final data storage.7

8Sample control is guaranteed at the arrival at the CDI Central Lab: transporttemperature, sample integrity and correct modules filling are managed byprofessional personnel.Database and reporting are built ad hoc. Investigator manuals for each centreinvolved in the study, can be provided in different languages with photos anddetailed descriptions of sampling operations.Customized clinical kits for sample collection are provided with proper packaging,personalized labels, quality control before shipment, traceability of the material andpotential ti recall procedure.CDI’s auditorium is available fortraining meetings and the team isable to arrange business meals,study explanation and information,preparation of presentation materialsor organizing teleconferences.Sample storage at controlled temperature can be provided for a period of timepreviously arranged with the Client as well as for documentation archiving, paperreports included.The CDI Central Laboratory offers a turnkey service including logistics, reportsdelivery and the constant monitoring of the materials stock at various testing sites.The staff directly involved in the clinical trials is informed of the contents of GCPs andconstantly updated on the development of technical and organizational norms.Moreover, before the beginning of a new trial, all the staff involved is specificallytrained in a traceable way.8

CONTACT US:CDI Laboratory Director: Vittorio i Grazioli, MDPhone: +39 0248317.499Mobile: +39 3355834344E-mail vittorio.grazioli@cdi.itCDI Scientific Supervisor: :EnricoMagliano, MDE-mail: enrico.magliano@cdi.itCDI Clinical Trials Coordinator: Katia Roda, MSc Clinical ChemistryPhone: +39 0248317.391E-mail: katia.roda@cdi.itCDI Clinical Trials Assistant: Stella Mondonico, MSc BiologyPhone: +39 0248317.583E-mail: stella.mondonico@cdi.it