Study Design Randomized, double blind study with 1560 patients
Indication HIV
Participating countries India, South Africa, Uganda
Project Scope
  • Handling of Local FDA, CDSCO & export.
  • Protocol interpretation for designing packing of IMP to maintain the blind.
  • Manufacturing of Test and placebo within India.
  • Primary packing in bottles , labeling of Bottles with randomized multi language, multipanel label.
  • Assembling of bottles in labelled patient kits as per protocol.
  • Shipping directly to sites in India, South Africa, Uganda at 15 Deg C -25 Deg C.
  • Handling, returns & destruction from Indian sites.

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