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Biostatistics And Programming

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

  • Pharmacokinetic and Pharmacodynamic Bioequivalence studies
  • SAD & MAD studies
  • Vasoconstriction and Dose response (DRC) studies for topical dermatologic corticosteroids
  • In-Vitro population bioequivalence (PBE)
  • Adhesion, Irritation and Sensitization (HRIPT) analysis
  • Statistical analysis of Carcinogenicity studies
  • Bootstrap analysis
  • Cut point, Sensitivity & Specificity analysis
  • Equilibrium & Kinetic Binding data

Phase II- IV

  • Strong statistical expertise in Phase I-IV studies, patient registry trials, Post-Marketing Surveillance studies and Claim studies.
  • Statistical input to study design and selection of primary endpoint(s)
  • Various therapeutic areas like Oncology, Dermatology, Immunotherapy, Cardiology, Diabetology, Psychiatry, Ophthalmology etc.
  • Well-defined SOPs, checklists and documentation driven processes.
  • Team of certified SAS programmers and Biostatisticians
  • Ophthalmic
  • Psychiaty
  • Rheumatology
  • Infections and infestations
  • Injury, poisoning and procedural complications
  • Musculoskeletal and connective tissue
  • Renal and urinary
  • Reproductive system and breast

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

Let’s Talk

Phone
+91 79661 35601
Address
17, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway, Bodakdev,
Ahmedabad - 380054.
Email
info@solvius.com