Malaria

Study Design Randomized, double blind study with 4150 patients
Indication Malaria
Participating countries Vietnam, Afghanistan, Pakistan, Indonesia, Ethiopia, India
Project Scope
  • Handling of Local FDA, import, CDSCO & export.
  • Protocol interpretation for designing packing of IMP to maintain the blind.
  • Label translation & booklet Wallet designing as per treatment.
  • Manufacturing of IMP’s, Primary packing in blisters. Packing of Blisters into cards & labeling of Wallet with booklet labels. Assembling of Wallet in labelled patient kits.
  • Shipping to sites in above countries at 15 Deg C -25 Deg C.
  • Handling, returns & destruction from Indian sites.

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