华美北辰 PolarisConnect: 独一无二的运营管理是您最好的选择

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• Study planning and set-up
• Communication strategy and plan
• Study project management, oversight and dashboard
• Study start-up
• Project team training
• Investigator meetings and sites training
• Proactive site engagement and management
• Site identification and selection
• Site qualification
• Site initiation and regulatory IRB submissions
• Patient enrollment plan and retention
• Clinical monitoring plan, trial monitoring & visits
• Proactive clinical data review and risk monitoring
• Clinical sample management
• Central and specialty lab management
• Medical imaging service management
• Clinical supply management
• Trial master file management
• Central hosting of clinical trial management system for client projects

• Overall study feasibility in US, IND investigator search & selection
• Clinical trial design, protocol feasibility assessment
• Synopsis, Protocol & ICF (informed consent form) creation
• QC review of study protocols & IB
• US clinical trial landscape assessment
• Patient population analysis, recruitment strategy and plan
• Patient advocacy groups
• Real world data (RWD) enabled PI and site identification and patient recruitment
• Preferred clinical site networks by study phases and diseases
• Phase I unit selection for PK studies
• FIH study assessment
• Market competitive landscape analysis & clinical pipeline
• Clinical innovations including digital strategy for clinical trials, eClinical technologies,  Virtual Trials, ePRO, etc.
• Licensing due diligence for clinical stage compounds

• Vendor selection and management
• Vendor performance
• Central management of all clinical vendors and service providers
• Preferred clinical vendor network
• Central management of all study contracts, budgeting & payments
• Central support and management of investigator site payment
• Standard contract terms development
• Establish clinical trial operations in US
• Build clinical operations team
• Conduct clinical operations trainings
• Functional outsourcing:

                -  Study management

                -  Site identification & patient     

                   recruitment

                -  Monitoring and site management

                -  Clinical data review and risk 

                   monitoring

                -  Clinical SOPs

                -  Contracts and vendor 

                   management

                -  Medical writing

• Safety & medical monitoring
• Patient narrative writing
• Clinical trial posting, updates and results to clinicaltrials.gov
• Clinical study report
• Medical publications

• Gap analysis of current clinical SOPs
• Development and creation of Clinical Operations SOPs
• Clinical SOPs trainings and training materials 
• Hosting & management services of GCP SOPs and training records for clients
• Maintaining validation records of clinical systems for clients
• GCP audit preparation and trainings

• Landscape assessment of RWD and digital innovations for clinical trials
• Strategy and implementation of RWD and digital capabilities 
• Virtual trial strategy and implementation roadmap
• Network of "clinical research as a care option" for patients and research clinicians
• Provider & patient oriented research data platform for Precision Medicine Practice 
• Connect healthcare with clinical research and clinical trials