| Gynecology |
UTI |
Bioequivalence Clinical End Point Study |
32 |
2 |
- US Based sponsor
- Total Sample size 200 subjects.
- Thirteen sites in US managed by sponsor.
- Recruitment in India completed in 1 month
- Etico team handled Indian regulatory approvals, site
management
identification and management of vendors.
|
| Gastroenterology |
Duodenal Ulcer |
Bioequivalence Clinical End Point Study |
600 |
30 |
- US Based sponsor
- Planned screening - 7500 subjects
- All sites in India
- Contracted full study;from regulatory (India & USA)
services, site
management , IP building, storage and distribution to
final CSR
|
| Autoimmune and Inflammatory Diseses |
Rheumatoid Arthritis |
Bioequivalence Clinical End Point Study |
1500 |
30 |
- Study completed in 12 months time
- Successfully completed the US FDA site audits
- Data accepted by the US FDA, No 483
- First to File for the sponsor
|
| Neurology |
Parkinson - USA & India |
Phase II |
74 |
7 |
- Sample size 174 subjects, 26 US sties recruited 100
subjects
over 12 months . Indian sites recruited 74 subjects in 5
months
- Etico team handled vendors like training (neurological
scales), lab,
electronic patient diary, lab shipment and drug
distribution
- FDA accepted the data, Phase III study in planning.
|
| Neurology |
Stroke-India, Canada & USA |
Phase II |
90 |
10 |
- Sample size 124. Us & Canada 6 sites.
Recruitment time 4 & 6 months in India & US.
Canada respectively
- The study was managed by Etico team including US and
Canada
sites.
|
| Neurology |
Schizophrenia - USA, India , Philippines,
Malaysia & Moldova
|
Phase II |
228 |
16 |
- Recruitment was completed in 10 months
- Etico team managed the study in all regions
- Sponsor had a successfull End-of-phase II
metting with US FDA
|
| Ophthalmology |
Diabetic Retinopathy
|
POC |
50 |
1 |
- Successfully completed the proof of concept
study in Bangladesh
- Sponsor is filling the IMPD in Europe
|
