Services
With proven experience in the medical device industry, clinical research, clinical data management, and healthcare data for AI, SP Clinical Studies & Healthcare Data provides professional high-quality services to meet clients’ needs in the following areas:
Clinical Studies Management
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Clinical studies design from concept to closure
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Design, development, and preparation of study protocols and other study-related documents
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Negotiation and supervision of clinical trials agreements and budgets
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IDE, IRB, and/or EC submissions
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Identification, selection, and qualification of clinical sites and investigators
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Management of relationships with study staff and attendance/management of study visits
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Set-up and maintenance of Trial Master File
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Ensuring compliance with Good Clinical Practice
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Ensuring study milestones, budgets and timelines are met
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Providing R&D, Marketing support, etc.
Clinical Procedures, Reports and Publications
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Establishment and maintenance of clinical standard operating procedures (SOPs)
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Preparation of interim and final clinical trial reports
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Writing and editing white papers, scientific abstracts and articles
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Conducting clinical evaluations
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Conducting literature reviews
Clinical Data Management
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Establishment and maintenance of clinical data management plans
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Design, development and set-up of electronic case report forms (e-CRF)
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Ongoing management of data collection process
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Supervising data validation, cleaning and extraction
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Preparation of database lock
Healthcare Data for AI
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Identification of and collaboration with healthcare data providers and data annotation vendors
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Design and development of data collection and annotation procedures