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Experience

115

Phase II-IV Studies in 20 Therapeutic Categories

600

Consumer Research Studies

324

CDISC Submissions

5257

BA/BE studies

31

FIH studies

27

SAD/MAD Studies

24

Drug - Drug interaction

23

PK/PD Studies

15

Food effect studies

50

Tobacco Research Studies

Services

  • BE & Clinical trial study design and Statistical inputs in Protocol

  • Sample size determination ( nQuery/Pass/SAS – software)

  • Producing randomization schedules

  • Statistical Analysis Plan (SAP) with mock-shells

  • Data submission using CDISC format / Sponsor specific requirement

  • TFL Development and Validation using SAS software

BA-BE / Phase 1

Phase II- IV

Consumer Research

Safety Testing Efficacy Studies Personal/baby Hygiene OTC Products Cosmetics/Beauty Care
Irritation (PIPT, HRIPT, Cumulative irritation, Scalp & Ocular irritation) Expert graders Antiperspirants
Deodorants
Acne, Cold sore, Wound healing, Pain Makeup, Cleansing Products, Moisturizers
Sunscreen safety Physician evaluations Liquid & Bar Soap Eye & Foot care Lip/Nail/ hair care
Oral Tolerance Bioinstrumentation/
digital photography
Shampoos, Diapers/Wipes Nutritional, Vitamin, Weight management Age spot, Cellulite
Comedogencity Consumer questionnaires Rash cream/lotion Dandruff/Seborrehic Dermatitis, Lice Line and wrinkle reduction
Photo Allergy / toxicity Smoking cessation Sanitary Lubricants skin elasticity

Biostatical tools

Phoenix® WinNonlin®
SAS®
PASS (Power Analysis & Sample Size)
nQuery
CDISC Services