Biometrics

By: Osmovian  19/11/2011
Keywords: project management, Clinical Trials, clinical research

Osmovian has a strong heritage in biometrics. Osmovian biometric services can be provided as stand-alone or as part of an integrated full biometrics service offering.

As part of the full biometrics service offering, Osmovian project managers will provide oversight to ensure cohesiveness and efficiency in planning, execution and delivery of projects.

 

  • Project Management
  • Clinical Data Management
    • CRF design, database development, edit check programming, data entry, discrepancy management, and medical coding
  • Statistical Programming
    • CDISC compliant datasets, derived datasets, tables, figures and listings
  • Biostatistics Analysis and Reporting
    • Protocol design, statistical analysis plans (SAPs), statistical reports, regulatory meetings (including FDA and EMA), DMC support, consultancy and training
  • Medical Writing
    • Protocols, Investigator Brochures (IB), Investigational Medicinal Product Dossiers (IMPD), patient safety narratives, Clinical Study Reports(CSR), electronic Common Technical Document (eCTD) content including Integrated Summaries of Safety (ISS) and Efficacy (ISE), rapid responses, consultancy, training, and Standard Operating Procedures (SOPs)
  • Scientific Communications
    • Publication planning, manuscripts, conference material (abstracts, posters and slide sets), editorial support, patient information and education material, and consultancy and training
  • Keywords: clinical research, Clinical Trials, Consultancy And Project Management, Medical Trials, project management, regulatory requirements

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