Consulting

Clinical Efficacy

Does it work is the critical question in  early clinical development. Once this hurdle is  taken the question evolves into does it work enough.

Reflected and informed design of the clinical development strategy overall and individual clinical trials is essential for candidate therapeutics, so they are given the best possible chance to reveal their potential and convince stakeholders.

Right the first time is an essential paradigm for start-up- and small biopharmaceutical companies in this regard. Aretaeus offers clinical and clinical development expertise, modelling and simulation services, and Bayesian decision support for biopharmaceutical companies.

Consulting

Clinical Safety

Managing clinical safety during the life-cycle of a biopharmaceutical product is a discipline in its own right. Methods and thinking are distinct from those applied when characterizing product efficacy.

Consulting services cover the full life-cycle of safety management from the decision to conduct the first in human study, over interim safety assessments during clinical development, safety monitoring, integrated safety data analysis to  oversight over product safety in the market place.

Services are tailored to start-up, virtual- and small companies

For educational services on drug safety and pharmacovigilance go to www.drugsafetymedicine.com

Consulting

Regulatory Strategy

The clincial regulatory strategy is closely linked to the demonstration of compelling efficacy and safety. However, it extends beyond these. To achieve a smooth review process and ultimately regulatory approval requires a nuanced appreciation of how best to present information in the clincial dossier, in order to build a coherent and convincing case. It requires the unique combination of a sound command of the English language, state-of-the-art medical and clinical research expertise, and  a deep insight into the regulatory review process. Aretaeus offers all of these and can support you in this critical endeavour.