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Clinical Data Management

Business & Decision provide industry leading clinical data management services and solutions, collecting, cleansing, analyzing and preparing clinical data for regulatory submission, within the timescales needed to meet tight project deadlines.

Ever increasing time and budget constraints on the collection, cleansing, analysis and preparation of sponsors clinical data has changed the landscape in clinical data management.  Business & Decision's experienced team of data managers understands that clients need a high quality service tailored to their needs.  Business & Decision's undertake the responsibility of assisting sponsors to meet their data management needs and: 

  • Integrate with Sponsors study teams, and suggest solutions and improvements in the data management process.
  • Provide a single point of contact for communication with the Sponsor, and provide a dedicated team for each project.
  • Provide flexible data collection options, including connections to Sponsor's data management systems and RDC (EDC) providers.
  • Perform data management in a regulatory compliant manner and use tested, robust Standard Operating Procedures.

Data Management Solutions and Standards

With proven data conversion skills, Business & Decision offer a unique additional service which is not common in most classical CROs. As a standard service, Business & Decision's team can receive any type of data, and regardless of the content or structure can deliver your database package ‘eCTD ready' in the current CDISC SDTM standards:

  • The CDISC SDTM annotated CRF, including bookmarks
  • The CDISC SDTM datasets
  • The define.xml or CRT-DDS metadata
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