Bioclin Pre-clinical and Clinical Study Management:

Klinetics™, our rapid, cost effective PK studies program enables BioClin to offer a one stop shop which optimally designs, co-ordinates, analyses and reports your pre-clinical/clinical trials to meet tight timelines and ensure compliance with global regulatory agencies.

Klinetics™:

• Protocol Design
• CTA Submission
• IMP Import / QP Release
• Clinical Batch Stability
• Clinical Conduct
• Assay Validation
• Bioanalytics
• PK / Statistical
• ICH Integrated Reports

Pharmacokinetics:

The following services are available to maximise efficiency and ultimately ensure biostudy approval.

• Study randomization schemes
• Sample size and statistical power estimation
• Blood sampling times
• Protocol development, review and approval

A range of pharmacokinetic approaches can be applied to the biodata to maximise return from the study - types of analyses available include:

• Bio-availability and Bio-equivalence assessment
• Non-compartmental analysis
• Mathematical modeling and simulations
• Convolution / deconvolution
• In-vitro and in-vivo correlation
• Urinary analysis

Additional Bioclin Laboratories Services:

• Pharmaceutical Analysis

• Bio-Analysis

Visit http://www.bioclinlabs.com/ for more information.