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 across all stages of drug development, 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.

Model-Informed Drug Development (MIDD) Consulting

At Occams, we leverage many decades of collective experience to provide expert model-informed drug development (MIDD) consulting. Quantitative modeling is no longer just a supportive technical activity: it is a formalized, decision-support discipline central to modern pharmaceutical development.

With the adoption of the harmonized ICH M15 Guideline, global regulatory authorities have established a rigorous framework for evaluating model credibility, context of use, and risk. Sponsors must now systematically define and justify their modeling evidence to meet these standards.

Our team of highly experienced pharmacometricians helps clients navigate this evolving regulatory environment. We provide comprehensive strategic support for regulatory submissions, including the creation of formal ICH M15 Evidence Assessment Tables.

Working closely with your pharmacometric, clinical and regulatory teams, we systematically document:
• Question of interest: The specific regulatory or development question a model is intended to answer.
• Context of use (COU): How the model will be applied within the decision-making process.
• Model risk and influence: The degree to which a decision depends on model outputs and the potential consequences of those decisions.
• Model impact: Tailoring the depth of model evaluation to ensure regulatory expectations remain scientifically justified and fit-for-purpose.

Whatever the task - optimizing a clinical development plan, predicting clinical outcomes, justifying pediatric dosing regimens, or any other model-centric activity - Occams can ensure your MIDD strategy is robust, transparent, and ready for submission to regulatory authorities.

Regulatory services

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 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 has earned 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 produced to a very high quality standard, are fully traceable and referenced, and are delivered with 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, nlmixr2, and Shiny) as we need them. Installation of all the tools we use is fully standardised and validated.