Data Management

International HealthCare’s (IHC) real-time management of clinical data and continuous quality control are central to the quality service our clients demand.

Our services encompass all elements of data management from data capture through database lock and data reporting.

463029101-data-managementIHC partners with multiple EDC service providers to provide a variety of database platforms to suit specific trial needs.  We do not use a proprietary EDC system that requires our clients to force fit technology with their project.  Our model ensures an EDC system is applied strategically, and therefore can offer a cost effective solution with timely control of study data. 

We then integrate pertinent data fields and trial management reporting outputs to provide ‘real-time’ review  of study data. Benefits to the client are found in compliance and strategy. We also do not force fit reporting tools and systems that are not needed for a specific program or are not cost effective for the value-added.

Compliance

International HealthCare is a member and sponsor of CDISC. Data standards and the management of data integrity are the principles by which we operate. Accordingly, we are proud to provide:

  • 21 CFR Part 11 Compliance
  • Qualified data centers
  • SOPs – written and conforming to ICH Guidelines
  • Industry validation standards

Strategy

International HealthCare’s strategy offers greater accuracy in study data collection and ensures
unparalleled data management by integrating:

  • Case Report Form design
  • All methods of data capture with integrated imaging
  • “Real-time” data review, data management and query resolution
  • Coding – industry standard or custom dictionaries
  • SAS tables & listings
  • Data updates on demand

The IHC Advantage

  • Fewer enrollment errors
  • Reduced cost of data collection
  • Reduced cost of data clarifications
  • Fewer number of data queries
  • Less time to database lock
  • Faster identification of data errors
  • Faster resolution of data errors
  • Faster completion of the clinical study
  • Less time to final data analysis