Product/Service

Data Management

Source: PAREXEL International

Parexel
We have extensive data management, biostatistics and clinical programming expertise in migration and integration of data from multiple sources across a large number of therapeutic areas.

We have extensive data management, biostatistics and clinical programming expertise in migration and integration of data from multiple sources across a large number of therapeutic areas. Ultimately our sponsors have consistent and successful results with meeting data repositories, integrated datasets for analysis, and integrated summaries of safety and efficacy (ISS/ISE) submission regulations with regulatory authorities worldwide.

We can meet your needs, whether your goal is for pharmacovigilance, drug development and discovery, submission-ready datasets, or any other goal of your organization's desire to have data combined for any reason.

Benefits of Migration

  • Standardization of legacy data from archaic database systems
  • Standardization of data from multiple sponsors and vendors
  • Consistency in data (coding, variable naming, format catalogues, derived variables, etc.)
  • Ease of integration
  • Ability to use Sponsor-specific or regulatory required formats

CDISC SDTM and ADAM

  • Proactively anticipate future regulatory requirements for submission data
  • Automatic consistency
  • Ahead of the curve when CDISC becomes mandatory for e-submissions
  • Streamlined integration

Delivery of Migrated Data

  • Products
  • Data conversion plan
  • SDTM/ADAM domain datasets
  • Trial Design Datasets
  • Case report tabulation data definition specification ("DDT" or "define" document (.xml, .pdf, etc.)
  • Methods
  • Development process
  • Established, structured workflow streamlining the creation of SDTM/ADAM deliverables
  • Direct mapping of protocol-defined assessments with
  • SDTM/ADAM domains to optimize database design and minimize downstream conversion requirements
  • Provision of in-stream data
  • SDTM/ADAM mapping services - mapping to SDTM/ADAM domains from:
  • Protocol-defined assessments
  • EDC/CDMS database elements
  • Datasets
  • SDTM/ADAM conformance reports

Data Integration

  • Products
  • Analysis plans for the integrated summaries of safety and efficacy (ISS/ISE)
  • Integrated safety and efficacy datasets
  • Integration of data sets in any format and from any source
  • Consistent coding across studies
  • Data Integration Plan
  • Integrated analysis and reporting of safety and efficacy data
  • Patient profiles/narratives
  • Case report tabulation data definition specification ("DDT" or "define" document (.xml, .pdf, etc.)

Project Management
A multi-function, collaborative approach to ensure that the deliverables are conform with sponsor or regulatory Authority guidelines, conventions and standards

Consultancy

  • Mapping plans and strategy
  • Data repository design optimized for SDTM/ADAM implementation
  • Systems and process analysis to advise on strategies for SDTM/ADAM implementation
  • Client data dictionaries; creating SDTM/ADAM repositories
  • Pre-submission meeting preparation and attendance
  • Advisory Committee meeting preparation and attendance
  • Post-submission support for ad hoc regulatory authority questions

Training

  • Ranging from high-level overviews to detailed technical implementation
  • Customized training courses tailored to meet client requirements