||Randomized, double blind study with 4150 patients
||Vietnam, Afghanistan, Pakistan, Indonesia, Ethiopia, India
- 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.