Phase I and Bioequivalence Consultancy Services

Pharmacokinetics and Biostatistical Data Analysis

Our company provides the following services and consultancy for bioequivalence, bioavailability, phase I, non-inferiority and other pharmacokinetic related clinical studies.

Administrative Services

Development of clinical study synopsis
Review of clinical study synopsis
Clinical study design development
Review of the clinical study design
Clinical study protocol development
Study protocol review
Case Report Form design
Case Report Form review
Estimation of study sample size
Design of biological fluid sampling
Regulatory support services for clinical trials
etc.

Data Analysis

Randomisation list generation
Coding/Decoding of the analytical data
Pharmacokinetic evaluation of study data
Pharmacokinetic review of study data
Statistical analysis of study data
Statistical results review
Interpretation of statistical results
Listing and tabulating results
PK and statistical report preparation
PK and statistical report review
Answering deficiency letters
Regulatory support and consultancy
etc.

Other Services

Consultancy for phase I CRO set up
CRO review, evaluation
Site selection of the clinical study
Standard operating procedure development
Existing SOPs review
Internal process review
Bioequivalence study report review
Answering deficiency letters
New product development process evaluation
Regulatory support for new product development
etc.