Clinical Data Management

Insight driven data management

With our proactive approach to clinical data management, we look at the “big picture” to design the best practical solutions for your project, streamlining all programming and data coordination tasks to minimize timelines and costs. We have the know-how and experience to react rapidly and flexibly to any changing requirements and ensure that your data is in compliance with the industry standards and best practices. Scope International is a member of the Society for Clinical Data Management.

To find out how we can support all your clinical data management needs, simply contact us.

An effective and CDISC compliant Data Management is a matter of course for us.

Our CDM services

  • Design of paper-based case-report forms (CRFs), subject diaries and completion instructions in compliance with CDISC CDASH
  • e-CRF development
  • Development of data management documentation
  • Development, validation and release of clinical database and other data processing systems
  • Data integration and development of data-transfer specifications, programming and validation, test transfers, regular data transfers
  • Double-data entry of paper-based CRFs
  • Centralized evaluations, e.g. central-diary evaluation and clinical outcomes assessment evaluation
  • Automated and manual medical coding of adverse events and medical history by trained medical monitors using standard dictionaries such as MedDRA and WHO-DDE, plus handling of any dictionary changes and updates
  • Ensuring data quality (e.g. data validation, data monitoring, manual data review)
  • Database lock and preparation of deliverables for archiving, including verification, integration of final data and final reconciliation
  • Tracking and reporting project progress; development of customizable progress reports
  • Regular data transfers and permanent data access (e.g. subject PDFs, Raw and SDTM datasets, subject profiles, data listings and summary tables)
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