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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.
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
Patch Studies
35,915+
female volunteers patch studies
2,460+
patient population patch studies
Oncology, Hypertensive
Diabetic and Renal
elderly male patch study
1,200+
female menopausal patch study
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