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PROPOSAL FOR CONDUCTING CLINICAL TRIALS OF PHASE I OR PHASE II OR PHASE III NEW DRUGS OR INVESTIGATIONAL
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PROPOSAL FOR CONDUCTING CLINICAL TRIALS OF PHASE I OR PHASE II OR PHASE III NEW DRUGS OR INVESTIGATIONAL
Name of Applicant
Nature and constitution:
Select Option
Proprietorship
Partnership including limited liability partnership
Company
Society
Trust
Philanthropist
Other to be specified
Number of research years experience Details of investigational new drugs:
Select Option
0 - 2
2 - 5
6 - 10
11+
Proposed clinical trials for New drug for Rare disease:
Select Option
Batten Disease
Duchenne muscular dystrophy (DMD)
CANDLE Syndrome
Childhood Interstitial Lung Disease
Cystic Fibrosis
Ehlers-Danlos syndromes
Ellis Van Creveld syndrome
Gaucher disease (Types 1, 2 and 3)
Haemophilia
Hemangiomas
Hirschsprung disease
Krabbe Disease
Neuroblastoma
Pompe disease
Sickle-cell Anaemia
Spinal Muscular Atrophy
Thalassemia
Autism
Others
Therapeutic class:
Country of present clinical trials phase approved:
Clinical trial protocol number:
Estimated period of clinical trials in India:
Estimated Budget required:
Details of approvals required:
Ethics committee details:
Dose form and composition:
Name of the investigatory/principal scientist in India:
Address:
Mobile/Landline No:
Email:
Submit
