Insights

White Papers and Case Studies

Access our brochures, factsheets to gain an insight into our business. Our case studies and success stories are a testimonial to our performance and quality of service.

White Papers

Trials and tribulations of clinical research teaching and training

Clinical research institutions have mushroomed in the country, though there is a generalized lack of experienced faculty. This in turn affects the quality of people that the industry requires, in order to ensure a high growth rate of the industry. The industry, in addition to facing a severe crunch of high quality professionals, is also suffering from attrition that is a common feature. To improve overall standards of professionals entering clinical research, institutes and the industry need to get together and work in close co-operation.

Case Studies

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.
Study Design Randomized, double blind study with 6500 patients
Indication Neurology – Pain Management
Participating country Australia
Project Scope
  • Handling of Local FDA, import trough DGFT & export.
  • Protocol interpretation for designing packing of IMP to maintain the blind.
  • Primary packing in blisters, labeling of blisters with randomized single panel label. Assembling of blisters in labelled patient kits as per dose regimen.
  • Shipping to our depot in Australia at 15 to 25 Deg C
  • IVRS services
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.
Study Design Randomized, double blind study with 3000 patients
Indication Diabetes & Cholesterol Management
Participating countries South Africa, Malaysia, Thailand
Project Scope
  • Handling of Local FDA, import, CDSCO & export.
  • Import of innovator tablets & DB capsules.
  • Stability study.
  • Blinding of IMP with over encapsulation.
  • Primary packing in bottles, labeling of bottles with randomized double panel label. Assembling of bottles in labelled patient kits as per dose regimen(Run in and treatment).
  • Shipping to sites in India and depots of South Africa, Malaysia & Thailand at 15 Deg C -25 Deg C.
Study Design Randomized, double blind study with 2,06,000 patients
Indication Cholera Vaccine Study
Participating country Bangladesh
Project Scope
  • Handling of Local FDA, CDSCO & Export.
  • Manufacturing of placebo Vials.
  • Secondary packing of IMP's with randomized single panel label.
  • Assembling of Vials in labelled patient kits as Dose regimen.
  • Shipping to Bangladesh at 2 Deg C to 8 Deg C.
Study Design Randomized, single blind study with 500 patients
Indication Rotavirus Vaccine Study
Participating country Nigeria
Project Scope
  • Handling of Local FDA, CDSCO & Export.
  • Secondary packing of IMP's with randomized single panel label.
  • Assembling of Vials in labelled patient kits as Dose regimen.
  • Shipping to Nigeria site at 2 Deg C to 8 Deg C.