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CRD TEAM
Healthy Volunteer Studies
Clinical Research Department
Within BA BE studies, Veeda has an expertise in conducting the following types of studies:
- Fasting and Fed condition studies.
-
Single and multiple dose.
Drug-drug interaction (DDI). -
Topical Transdermal Patch Studies
- Patch application duration from 24.00 hrs to 120.00 hrs
- Experience & trained staff for application of patch on body ( e.g. Lower abdomen, Upper arm, Upper back etc.)
- Experience & trained staff for Adhesion scoring
- Short to Long residency Studies
- Oral Inhalation - Pulmonary deposition & Therapeutic Equivalence Study
- Pharmacokinetic interaction studies
- Intravenous Anesthetic drug BE study (e.g. Propofol)
-
Glucose Clamp studies
- Experience of more than 750 clamps on healthy volunteers with clamp duration ranging from 4 hours to 36 hours.
- Total 11 glucose clamp studies conducted
- Dedicated Phase-1 unit and staff for glucose clamp study
- Dedicated YSI instrument for Glucose measurement during clamp study
Formulations
Solid Oral Formulations & Orally Dispersible Formulation
Tablets (Immediate Release & Modified Release e.g. ER, DR, SR),
Capsules, Soft Gels, Sprinkles etc.
Capsules, Soft Gels, Sprinkles etc.
Liquid Formulations
Suspensions, Syrups & Dry power
Parenteral Formulations
07
Sprays
03
Oral Inhalation
03
Derma Patches
03
Transdermal preparations
01
Clinical Experience
Inhalation Studies
- We have experience of 18 Inhalation Studies with different formulations including 13 pMDIs, 4 Dry Powder Inhalation(DPI) and 1 nasal spray
-
Benefits of dosing in a Negative Pressure Room
- Uniform environment with consistent temperature, humidity, air flow & oxygen content
- Eliminates cross contamination
- Better regulatory acceptance
Patch Studies
- Performed 08 studies for transdermal patch & Adhesion trials on 350 subjects
Glucose Clamp Studies
- Performed 11 studies with 750 clamps of different duration on 296 subjects with Euglycemic & Hyperglycemic conditions
35,915+
2,460+
Oncology, Hypertensive
Diabetic and Renal
Diabetic and Renal
1,200+
1,100+
WHY PARTNER WITH VEEDA?
- Veeda Clinical Research Organisation is an Independent Indian CRO with 14 years of experience.
- Veeda has conducted over 2000+ studies for USFDA/MHRA/EU
- Veeda has over 900+ healthcare professional
- Veeda has worked with over 200 pharmaceutical companies around the world, and has Master Service Agreements with many of the top global pharmaceutical companies
- Veeda has been audited 18 times in last 21 months and has had no 483
- We have over 760+ analytical methods
- Quality is part of our DNA.
- Completion of more than 35 pivotal bio studies to support more than 14 first to file including NCE-1 ANDA applications
Type of Study
Total Numbers till Jun-2019(Shivalik + Vedant)
Generic (BA/BE)
2632
Pilot
998
Pivotal
1602
Special Studies
32
Glucose Clamp
12
Phase I
20 (1 Phase II)
Regulatory Submission Numbers (For Generic studies #)
Pilot
Pivotal
USFDA
676
1001
EU & UKMHRA
208
370
Health Canada
5
106
ANVISA
11
46
TGA
8
43
MCC
2
5
WHO
3
10
DCGI
4
6
Russia
1
0
Chinese FDA(CFDA)
75
8
GCC
0
4
Sri Lanka
0
1
Mexico
2
0
In-house
3
0
ROW
0
2
Studies of Different Dosage form@
Dosage form
Pilot
Pivotal
Inhalation
11
8
Suppositories / Rectal Products
1
3
Patches/Derma Products
2
7
Our exemplary regulatory track record
USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times