KNOWLEDGE, COMPLIANCE, QUALITY & CONVENIENCE @ WORK…..
Optimus provides contract research services focused on enhancing knowledge building in biomedical research and development through pharmacokinetic and pharmacodynamic analytics. Our services include clinical data analytics, modeling and simulation for R&D; decision support, optimization of clinical trial designs, model-based data analysis, and regulatory report preparation as well as general consulting in the areas of pharmacokinetics and pharmacodynamics.
Our team of experienced pharmacokineticists, pharmacologists, clinicians, statisticians and programmers produce high-quality, timely analysis and reporting of study results across a broad range of therapeutic areas. We have extensive knowledge of regulations, regulatory expectations, study design, statistical methodology, and global regulatory requirements for pharmaceuticals, biologicals, medical devices and combination products. We provide the following services :
Our dedicated Pharmacokinetics group works closely with both internal and external customers to provide pharmacokinetic and statistical interpretation components of clinical study reports in a timely fashion, utilizing industry-standard WinNonlin® software.
Our pharmacokinetic consultancy service provides advice and support for all aspects of clinical pharmacokinetics. Upon request, pharmacokinetic parameter estimation output and reports may include a comprehensive text interpretation of the data. The know-how spans the range from Lead Identification (LI), Lead Optimization (LO), Entry into Humans (EIH), Phase I and Phase II clinical studies.
We also provide very focused pharmacokinetic solutions for Bioavailability / Bioequivalence customers and clinical research / development customers, starting from study design, data analysis, data interpretation, study reporting, providing consulting solutions for formulation and pk/pd development teams based on generated data – all of these services packaged and presented as a unique solution offering integrating people, technology, workflow, regulatory compliance, quality assurance, methodology, standard templates and customised project management.
The team at Optimus is flexible to fit your needs. We can provide selected or comprehensive services of this solutions offering as required to meet your specific program needs.