Data Management

Taking advantage of extensive experience in building and operating Electronic Data Capture (EDC) systems, we provide one-stop services from the initialization of data management (DM) tasks through to operations.

Experience and track record

  • We have worked on DM projects ranging in size from as few as 10 cases through to as many as 1,300 for clinical trials and 13,000 for postmarketing surveillance.
  • Your trials will be protected by SAS-based logical checks to ensure data integrity.
  • We have also developed custom systems to support DM, such as those for reinvestigation request management.
    e.g.) ClipCapture, Rave, RaveX, DATATRAK ONE, PostMaNet, EDC Plus, and InForm

Our extensive experience in Clinical trial and Postmarketing surveillance areas 

  • Oncology
  • Neurology
  • Endocrinology and metabolism
  • Ophthalmology
  • Gastroenterology
  • Urology
  • Nephrology
  • Cardiovascular
  • Vascular surgery
  • Obstetrics and gynecology
  • Vascular
  • Respiratory medicine
  • Infectious diseases and immunology

Postmarketing surveillance areas with extensive experience

  • Oncology
  • Cardiovascular
  • Obstetrics and gynecology
  • Endocrinology and metabolism
  • Vascular
  • Respiratory
  • Infectious diseases and immunology
  • Neurology
  • Ophthalmology

Key services

  • With many industry experts you can be assured that any investigation regardless of scale will be handled accurately and promptly.
  • Flexible support that can be adjusted to meet your needs
  • We have qualified doctors, veterinarians, pharmacists, nurses, and clinical laboratory technicians available to provide expert support.
  • We have a large team which allows us to promptly respond to changes in your business or operational conditions. Our distributed offices across Japan in Tokyo, Osaka, and Sapporo also give us the ability to quickly respond to potential threats to business continuity such as a pandemic.
  • If your needs change we can help manage your PV and progress management data. This way you can focus on your core tasks as your outsourcing scope changes.

Services

  • Preparation of procedures
  • Validation
  • Coding
  • Registration center
  • Data entry
  • Visual/logical checks
  • Preparation of DM reports
  • CRF preparation support
  • EDC vendor selection support
  • EDC system implementation support
  • EDC validation support
  • Data cleaning
  • Archiving

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