Modelling & simulation services
Occams provides services in the field of population pharmacokinetics, advanced PK/PD modelling, and drug-disease modelling and simulation.
The team at Occams has a wealth of experience in a wide range of application areas associated with PK/PD drug and disease modelling, with specific skills in longitudinal PK/PD, scaling of PK and PK/PD from adults to paediatric patients, tumour growth modelling, adverse event and effect modelling using repeated ordered categorical data, and modelling of viral dynamics, respiratory disease, diabetes, and repeated daily seizure counts in epilepsy.
Occams provides services in the field of preparation and/or review of documentation for regulatory submissions, and interaction with health authorities in matters relating to PK, PK/PD and modelling and simulation. We also have considerable experience with acting as the regulatory representative for clinical pharmacology during mock advisory board meetings.
We have many years of experience both within the regulatory arena and interacting with regulatory agencies from both academic and industrial perspectives. This makes us uniquely qualified to help our clients maximise the utility of model-based analyses with respect to gaining marketing approval.
Project conduct and reporting
Occams projects are typically performed on a milestone basis, in which intermediate results are shared and discussed with clients. This close cooperation with our clients ensures results that often exceed expectations.
Occams aspires to carry a reputation in the marketplace for delivering high quality results, on time. We achieve this by using innovative model-based analytical techniques, cutting-edge technology, the principles of reproducible research, our intimate understanding of pharmaceutical industry needs, and our extensive knowledge and experience of the field of modelling and simulation.
Occams reports are delivered with a full quality control audit performed by an external partner, and a complete transfer of project-related material (including all scripts and model code).
Tools and processes
Occams complies with all relevant regulatory guidelines, and our reported results are guaranteed to be fully traceable to source data to ensure complete reproducibility.
Our principal analytical tools are recent versions of NONMEM and R, although we often apply other complementary or supportive tools and technologies (such as PsN and Shiny) as we need them. Installation of all the tools we use is fully standardised and validated.