The average phase 3 trial generates 900,000 data points, with strict regulations on data format for regulatory submission. Excellent data management is, therefore, an essential requirement for sponsors:

  • Globally fragmented data sets requires specialised handling and tailored technology to aggregate data
  • Increasingly stringent data privacy laws require awareness of legal frameworks
  • Compliance with data standards is essential, requiring highly qualified staff
  • Shift to complex therapeutic areas requires deep domain expertise
  • Capacity management requires flexible resourcing

Navitas Life Sciences Is Here to Help

Navitas’ expertise is backed with state-of-the-art technology, industry affiliations, years of experience and qualified subject experts to deliver cost-effective solutions to address increasingly complex, fragmented clinical data sets.

  • Data services can be provided as an end-to-end service or á la carte according to capacity needs. Expertise includes clinical data management; stats/programming; data standardisation and medical writing.
  • “Follow-the-sun” business support teams, with optimal mix of on-shore and off-shore managers
  • Deep domain expertise through decades of working with world leading pharmaceutical and biotech companies
  • Highly qualified teams of certified programmers: Masters/Bachelor’s degree qualified with 2/4+ years experience respectively; including numerous SMEs with more than 5 years of experience in SAS Programming for Oncology studies
  • Unit pricing – only pay for volume of work completed

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