Home Mission Solutions Services Quality APP & Software WP News Work with us Contacts Services Clinical Research Technology Phone: +39 089301545 Fax: +39 0897724155 Mail: info@cr-technology.com Home / Services MEDICAL WRITING Study drawing design Drafting of Protocol (ICH-GCP) Case Report Form (CRF) Final report drafting (ICH-GCP) CENTER SELECTION Catchment area Scientific reliability Respect for protocol timing REGULATORY ACTIVITIES Management of Ethics Committees Documentation management Finalization of the economic agreement Obtaining administrative resolution DRUG MANAGEMENT Shipping Storage Packaging Labeling PROJECT MANAGEMENT Effective project management Identification of winning strategies Flexible budget models Costante reporting MONITORAGGIO Rapida pianificazione visite Visite pre-studio Visite start-up Visite monitoraggio Visite non programmate Visite fine studio Gestione file documentali DATA MANAGEMENT Monitoraggio validazione dati Attività approfondimento dati incerti Data Management Plan Gestione remota del cleaning dei dati Standardizzazione disegno database ANALISI STATISTICA Elaborazione statistiche Statistical Analalysis Plan Definizione criteri di randomizzazione MEDICAL TRANSLATION Esperienza consolidata nell’ambito medico Traduzioni accurate e certificate Revisione bozze di protocolli e documentazione generale Creazione di un glossario apposito GESTIONE EVENTI & MEETING Organizzazione meeting Workshop su specifici progetti PRODOTTI SERVIZI Clinical Research Technology Srl Operational and legal headquarters Via San Leonardo - Traversa Migliaro, 84131 - Salerno Telephone: +39 089301545 - Fax: +39 0897724155 - info@cr-technology.com Share capital Euro 10,200.00 fully paid-up Salerno Company Register and Tax Code N. 07501100635 - REA Salerno N.318452 - Part. VAT number 07501100635

Home Mission Solutions Services Quality APP & Software WP News Work with us Contacts Quality Clinical Research Technology Phone: +39 089301545 Fax: +39 0897724155 Mail: info@cr-technology.com Home / Quality Quality system ISO 9001: 2008 - AJAEU / 08/10434 Computer System Validation (CSV) - US FDA 21 CFR Part 11: Electronic Records; Electronic Signatures Since January 2008, CRT has adapted its quality management system to the ISO 9001: 2000 standard. Starting from January 2009 CRT has adapted its quality management system to the ISO 9001: 2008 standard. The latter will be subjected to annual verification by an accredited third party. The aim is to keep its quality system constantly updated and current. PRODUCTS SERVICES Clinical Research Technology Srl Operational and legal headquarters Via San Leonardo - Traversa Migliaro, 84131 - Salerno Telephone: +39 089301545 - Fax: +39 0897724155 - info@cr-technology.com Share capital Euro 10,200.00 fully paid-up Salerno Company Register and Tax Code N. 07501100635 - REA Salerno N.318452 - Part. VAT number 07501100635