Data Management

Utilizing 30 years of experience, CAC Croit balances cost and quality while performing data management (DM) tasks, delivering high-quality data for statistical analysis quickly and reliably.

 

Are you facing any of these issues?

  • You need better management of case status and progress.
  • You need to save time from answering queries from sites.
  • You need to consume less time reviewing draft queries.

Croit’s solutions:

  • We manage DM progress and provide reports and reminders.
  • We have a call center to respond to queries from sites.
  • We manage and store all responses and queries.

Services

We support all activities from the DM start-up process through to operations.
These services can also be provided partially at your request.

 

Services

 

 

*Only available for paper-based CRFs

Advantages of choosing us

  • We have numerous industry experts, and you can be assured that any investigation regardless of scale will be handled accurately and promptly.
  • We have a large team which allows us to promptly respond to changes in business or operational conditions. Our distributed offices across Japan in Tokyo, Osaka, and Sapporo also give us the ability to minimize potential threats to business continuity such as during a pandemic.
  • By managing and storing your previous responses and queries with a tool, your man-hours for reviewing draft queries can be saved.
  • If you outsource Croit for the entire process from monitoring through to applications,
    • you can reduce total cost as your overheads (such as start-up processes and communications) will be less than outsourcing items separately;
    • you can have an idea of your schedule and save time for tasks as we coordinate them.
  • Staff who participated in the CDISC Public Training will design CRF and SDTM* DB.
    *SDTM: Study Data Tabulation Model
  • We also support global clinical trials conducted in the US, UK, and Asia by communicating with your staff overseas and the monitors on site, as well as preparing documents in English.

Experiences

  • 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
  • We have experience locking database within 2.5 weeks of the last patient-out (LPO).
  • We have conducted global studies in the US, EU, and Asia.

Our experience in clinical trial and postmarketing surveillance areas

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

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