Classe 9
Computersperipheral hardware componentsblank external hard drivesblank flash drivesvideo cables; video capture devicessignal processorsvideo receivers and video recorders for converting signals from endoscopy machines to USB for storing on computers; Recorded video recording softwaredownloadable video recording software configured according to study protocol requirements for receivingstoring and securely sending clinical study dataobtained from using imaging endoscopic proceduresover the Internet to a secure website
Classe 35
Business project management servicesproject management of clinical studiesrecruitment and selection of clinical study sites and investigatorsmanagement of clinical study sites and clinical monitoringmanaging relationships between vendors and subcontractorsorganization and planning of meetingsworkshops and events; Records management servicesdocument indexing for othersspecificallycoordinating and controlling flow of electronic and paper documents; Data management services for use in pharmaceutical drug developmentpreparation of Case Report Forms (CRFs)Collection and compilation of information into computer databases in the field of clinical studies; Compilation and provision of statistical and biostatistical information; Medical coding services for others in the nature of coding clinical trial data for purposes of medical science and regulatory review and approvals
Classe 42
Technical writingmedical writing services for developing medical protocolsclinical study reportsinvestigator brochuressafety reportsinformed consent formsmeeting abstractspostersmanuscriptsstudy chartsmanuals and literature reviews; Providing an Internet website portal featuring clinical study and clinical trial management system tools; Electronic storage of files and documentssecure storage of electronic and paper documents; File sharing servicesproviding a website featuring technology enabling users to upload and download electronic filescomplete and inspection-ready trial management files; Electronic storage services for archiving databasesimages and other electronic data in the field of trial management files (TMF)TMF setuparchiving and management of TMP files through lifecycle of clinical study; Conducting scientific researchbiostatistics and statistical programmingprotocol development of sample size and power calculationsrandomization schedulesstatistical analysis plansstatistical programming and validation in statistical analysis systemstatistical analysesinterpretation and reporting of data for clinical trial reports and publicationsstatistical and strategic consulting for product developmentinterim analysis for early decision-makingdatabase integrationNew Drug Application (NDA) ready data listingsregulatory submission compliant datasetsthought leadership and operational experience with study data tabulation model and analysis data model regulatory submission standardsintegrated safety and efficacy summariesadaptive design consulting and simulation supporttranslational research support data monitoring board management and support; Medical research servicesmedical monitoring and investigator site monitoring in the field of medical review of clinical study materialspreparation of medical monitoring and safety planscontinuous trial oversight via patient level and safety data reviewsubject eligibility support for investigatorsmedical support to sites and study teams for interpretation of study protocolconsultation on potential safety issues and medical concerns and 24/7 medical monitor coverage; Pharmaceutical drug development services in the field of drug safetyspecificallyprocessing adverse events from clinical trialspreparing Development Safety Update Reports (DSURs) and other aggregate reportsperforming signal detection and benefit-risk assessmentspreparing safety management plans and preparing medical monitoring plans; Providing quality assurance services in the field of clinical trialsquality assistance documentationsuch as Standard Operating Procedures (SOPs) and work instructionsinternal system reviewssite auditsvendor assessments; Medical research services in the field of pharmacologydose simulationselection and optimizationselection of biomarkers and endpointsoptimization of trial designpopulation pharmacokinetic and pharmacodynamic modelingexposure response modeling; Medical research services in the field of translational medicineimmunohistochemistryflow cytometrytranscriptomicsproteomicsmicrobiome study; Providing medical and scientific research information in the field of clinical trialsthe design of clinical trials and outcome measures for studying human diseasesfor studying or testing drugsdevices or methods of medical treatment on humans in relation to diseases; Conducting clinical trials for others which study human diseasesstudy or test drugsdevices or methods of medical treatment on humans in relation to diseases; Custom computer programming of imaging adjudication and computer systems integration of eligibility data with Interactive Response Technology (IRT); Computer database design and implementation for data collectiondata storagedata managementdata analysisdata validation for use in pharmaceutical drug development; Compilation and provision of clinical study datacompiling data for research purposes in the field of medical science and medical consultancy
Classe 44
Medical imaging services; Medical diagnostic testingmonitoring and reporting services; Medical imaging serviceselectronic medical imaging support services for use in assessing patient health in clinical trialsreviewing and scoring electronic medical imagesincluding video imagesof patients supplied by others; Medical imaging serviceshistopathology support services for reviewing and scoring tissue sample images provided by others; Consulting services in the field of medical imagingmagnetic resonance support services for reviewing and scoring magnetic resonance images provided by others; Medical servicesendoscopy support services in the field of reviewing and scoring endoscopic images provided by others
Classe 45
Regulatory submission managementassisting others with preparing and filing applications for new drugs with government regulatory bodiessubmission planning and life cycle management of clinical trial applications to Competent AuthoritiesEthics Committees and Regulatory Agenciespre-approval submissionssubmission of supplementsamendments and variations applicationssubmission publishing and dossier compilation in electronic common technical document or common technical document formatsannual reportspaper submissions management and submission archival