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