Vitalograph Cardio-Respiratory Clinical Trials Services
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1 Vitlogrph Crdio-Respirtory Clinicl Trils Services Vitlogrph specilize in delivering stndrdized equipment nd centrlized crdio-respirtory dt cpture services nd ptient reported outcomes for clinicl trils. When you choose Vitlogrph s your clinicl tril prtner you cn be confident tht we hve the experience to understnd your requirements nd the expertise to mke them hppen.
2 Why Vitlogrph Customized softwre solutions Heritge nd expertise Our clinicl trils prtners enjoy the pece of mind tht comes from our 50 yer heritge of reserching, innovting nd developing high performnce crdiorespirtory devices which we hve delivered nd supported globlly in clinicl trils. Our success in providing high qulity clinicl tril dt nd opertionl efficiencies is reflected in the fct tht the mjority of our clinicl trils work is repet business. Our experienced tems of softwre engineers re experts in developing optimized softwre solutions to meet your specific protocol nd opertionl needs. This customiztion cpbility, coupled with flexibility, speed of response nd personl service mens we cn provide systems tht consistently deliver ccurte dt, on time nd on budget. Crdio-Respirtory devices All our devices re designed, developed nd mnufctured in ccordnce with ll relevnt medicl device stndrds. Globl study experience With offices in the United Kingdom, United Sttes, Irelnd, Germny nd Hong Kong, Vitlogrph hs delivered successful trils for mny of the world s leding phrmceuticl compnies, biotech compnies nd contrct reserch orgniztions, mny of which hve repetedly chosen us s their clinicl trils prtner. Dedicted project tem Our customized, personl service is mde possible by our experienced nd responsive tem which includes dedicted project nd dt mngers, softwre development engineers, interntionlly renowned over-reders, in-house QA nd logistic specilists, plus full mnufcturing nd 24/7 support cpbilities. Interntionl influence As one of the longest stnding members of the ATS nd ERS, together with our membership of other interntionl respirtory orgniztions, we hve well-estblished reltionships with key clinicl opinion leders nd cdemic institutions. These reltionships drive our development strtegy, llowing us to mke vluble contributions to best prctice in crdio-respirtory testing.
3 Services Powerful centrlized dt cpture Vitlogrph s unique Spirotrc Softwre, in combintion with expert overreding, reporting nd site trining, mximizes overll dt qulity nd reduces sources of vribility or errors. Spirotrc provides stndrdized systems cross ll sites nd cn be customized for ech study, with specific feedbck tilored to the protocol to fcilitte wide rnge of mesurements nd dt collection prmeters including spirometry, DLCO, FENO, ABPM, Holter, cough, crdic sfety nd ptient reported outcomes (epro). 24/7 Globl support As leding mnufcturer of crdio-respirtory testing equipment nd customized softwre, bcked up with our globl study experience, Vitlogrph is well plced to understnd the modern dy chllenges nd logisticl implictions of running multi-ntionl trils. Our expertise is complemented by customer focused, 24 hour, multi-lingul support tem trined in the specifics of ech protocol in order to deliver the best help desk support for our prtners. Comprehensive expert trining Our expert trining stff will design nd deliver custom trining progrm focusing on the relevnt testing guidelines nd regultions, protocol specific testing nd test qulity requirements for your tril. Our trining progrms re designed to enhnce technicin proficiency, resulting in decresed risk of protocol infringements, improved dt qulity nd higher confidence in your end-point mesurements. Trining cn be delivered in person t investigtor meetings, remotely or online. Dedicted project mngement Our project mngement expertise ensures tht studies run to scope, schedule nd budget, with ongoing ssessment nd mngement of risks. Ech study is ssigned dedicted nd skilled project mnger supported by project delivery tem with experience in the conduct of crdio-respirtory clinicl trils. Fst, efficient reporting Our project tem is ble to provide sponsors, CRAs nd site stff with rel-time custom reports from the centrlized study dtbse. Reports re delivered directly to site systems, vi emil or ccessible online using the Vitlogrph VIEWER web portl. Study specific metrics nd dt reports re vilble to sponsors t ny time, by country, site nd subject. Consulttion services Vitlogrph collbortes closely with wide rnge of interntionl crdiorespirtory experts nd regultory bodies on the development of performnce stndrds nd regultory requirements for medicl devices nd the conduct of crdic nd respirtory testing. This expertise mens we cn offer guidnce on the optimum dt collection nd logisticl strtegies to ensure successful outcome for your tril.
4 Rigorous systems nd processes Our robust Qulity Mngement System (QMS) is designed to protect the dt integrity nd success of your tril. Fetures include: Full complince with ICH/GCP nd ISO requirements Fully vlidted dt mngement systems with built-in fil-over systems t multiple Vitlogrph loctions everything is utomticlly bcked up nd continues to operte semlessly in the unlikely occurrence of n unexpected filure of ny individul system Automtic dt bck-up in ll site devices including e-diries Encrypted dt trnsmission system highly secure, fst nd cost effective vi the clinic s brodbnd connection or vi GSM from the ptient s home Web-bsed, on-demnd ccess to dt nd reports powerful tool for monitoring the progress of your study using Vitlogrph VIEWER Web services - PFT web cpture system Our PFT Web Cpture Systems llows for the electronic dt cpture of Lung Volume nd DLco dt t ny site with specilist lung function equipment. Where study needs or budget constrints preclude stndrdized equipment or specific device trining Vitlogrph Spirotrc Softwre provides fst, secure, high qulity dt cpture of most lung volume nd gs trnsfer vlues supported by our powerful centrlized QA review service. This verstile system cn be tilored to suit the exct requirements of ny primry or secondry endpoint. Devices Vitlogrph crdio-respirtory clinicl trils softwre devices Clinic Site Testing Pulmonry Function Lb Testing Home Monitoring Spirometry with f/v Loops nd IC Spirometry with Bronchil Chllenge Home PEF & FEV 1 Questionnires & epro Single Breth Diffusion (DLCO) epro Integrted with FEV 6MWT & Chllenge Testing FRC nd Lung Volumes Holter ECG Monitoring Aerosol Inhltion Monitor Respirtory Pressures & Muscle Strength Ambultory Cough Monitoring FeNO Crdio-Pulmonry Exercise Testing Home Pek Flow Pulse Oximetry Pek Cough Flow Ambultory Blood Pressure 12 - Led ECG Pulse Oximetry Sttic Blood Pressure
5 Vitlogrph Spirotrc Softwre Vitlogrph Spirotrc integrtes high qulity spirometry, 12-led ECG, pulse oximetry, COPD ssessment, blood pressure mesurement, chllenge testing nd more in flexible, integrted softwre solution. Vitlogrph In2itive ediry The portble Vitlogrph In2itive TM ediry integrtes dt with Spirotrc to deliver home PEF /FEV testing or full office spirometry quickly nd esily. Vitlogrph COMPACT The Vitlogrph COMPACT TM Expert is medicl worksttion tht integrtes high qulity spirometry, 12-led ECG, pulse oximetry, COPD ssessment, blood pressure mesurement, chllenge testing nd more in flexible, integrted desktop medicl device. Vitlogrph AIM The unique Vitlogrph AIM (Aerosol Inhltion Monitor) is designed to ssess MDI or DPI use. Vlidtion of stisfctory technique will support more ccurte drug nd dose delivery. Vitlogrph sm-1 The Vitlogrph sm-1 TM is simple home use electronic respirtory monitor tht mesures PEF nd FEV 1 nd my be integrted with smrt phones or tblets for epro dt collection. It offers greter ccurcy thn mechnicl pek flow meters nd elimintes the need for pper record crds.
6 Vitlogrph is world leding provider of outstnding qulity crdio-respirtory dignostic devices, clinicl tril services nd medicl equipment servicing. With pioneering heritge of excellence spnning hlf century Vitlogrph continues to mke vluble contributions to effective medicl cre nd enhnced qulity of life. Vitlogrph Ltd. UK Mids Moreton, Buckinghm MK18 1SW Englnd Phone: (01280) Fx: (01280) e-mil: Vitlogrph Ltd. Export Mids Moreton, Buckinghm MK18 1SW Englnd Phone: Fx: e-mil: Vitlogrph GmbH Rellinger Strße 64 D Hmburg Germny Phone: (040) Fx: (040) e-mil: Vitlogrph Inc West 99th Street Lenex, Knss, USA Toll Free: Phone: (913) Fx: (913) e-mil: Vitlogrph (Irelnd) Ltd. Gort Rod Business Prk Ennis, Co. Clre Irelnd Phone: Fx: e-mil: Vitlogrph Ltd. Hong Kong Unit 230, Corportion Prk 11 On Li Street, Shtin Hong Kong Phone: Fx: e-mil: Vitlogrph, Spirotrc, sm-1, AIM, COMPACT nd In2itive re trdemrks or registered trdemrks of Vitlogrph Ltd. PRINT REF: 19569_1
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