We conduct comprehensive Pharmacokinetic / Pharmacodynamic (PK/PD) and statistical data analysis using the industry standard. SRC uses WinNonlin Version 5.0.1 for noncompartmental estimations of pharmacokinetic and pharmacodynamic data. The installation of the software has been qualified and validated.

Benefits of WinNonlin Version 5.0.1

 

• It is the easiest and one of the most user friendly pharmacokinetics data analysis software available.
• Its Excel-based program provides wide flexibility in a familiar spreadsheet environment.
• Provides graphs and tables of the most widely used pharmacokinetic parameters.
• Helps you analyze, record, compare, and report pharmacokinetic and ADME study results.

The pharmacokinetics team is involved in the following activities

 

• Provide inputs to pharmacokinetic sections of the study design and clinical study protocol
• Development of PK/PD datasets to meet analysis requirements.
• Non-compartmental pharmacokinetics
• Preparation of pharmacokinetic sections of the clinical study reports and illustration with graphs, tables and charts.

SRC has expertise in both clinical and nonclinical non-compartmental analysis and reporting. Our Pharmacokineticists work closely with our statistical, scientific writing, and bioanalytical staff at all stages of the study from study initiation to study completion and reporting to ensure a smooth and effective transition of high-quality Pharmacokinetic data from our bio analytical laboratory to the Pharmacokinetics department and then to our statistical and medical writing groups and finally in the preparation of comprehensive ICH compliant reports.

Biostatistics

An independent Biostatistics department provides crucial statistical expertise for coordinating clinical trials. Our statisticians are involved in determining appropriate number of study participants to meet scientific and regulatory requirements, selection of appropriate statistical methods for assessing clinical safety and efficacy results and assuring statistical principles are appropriately applied to study design and conduct as well as data analysis and interpretation.

Our biostatistical services include

Protocol Preparation

Development of study design – Sample size/statistical power determination, Generation of Randamization Schedule – provide inputs to statistical section of protocols – Describe both interim and final analysis strategies

Report Preparation