A collaborative approach is key to bringing your therapy’s potential to light. As your dedicated partner, we offer deep, global experience in clinical trial design and execution, covering complex therapeutic areas and challenging indications. Our mission is to complement your internal capabilities with our expertise to support innovation in treatments for patients with unmet needs.

Small and mid-sized companies need a trusted partner that can support them with all aspects of data management, clinical data analysis, and biostatistics at every point in the development process. Our rigorous biostatistics services clarify your treatment’s efficacy and safety for regulatory bodies while meeting the data requirements of all clinical trial phases. We prioritize data integrity and efficiency, delivering to the highest standards on the most current data platforms.

Companies like yours come to us for one key reason — you trust the depth and breadth of knowledge we bring to your product development challenges, counting on dedicated support from some of the most respected regulatory and technical experts in the field. We can help you with regulatory, clinical, nonclinical, and CMC development planning strategies, health authority meetings, authoring and submission publishing, and support for GxP compliance and pharmacovigilance services.

Clinical pharmacology is essential for the development of safe and effective drugs and therapies. When utilized appropriately, the clinical pharmacology strategy is a road map to guide an efficient clinical development program. With modeling and simulation, prospectively planning and harnessing data from multiple sources will answer many important questions for your development program, including dosing and the value of the drug for patients.

Our specialized focus in Clinical Pharmacology, Model Informed Drug Development (MIDD), Pharmacometrics (PMx), and Pharmacokinetics/Pharmacodynamics (PK/PD) helps our clients improve drug development efficiency and probability of success and avoid costly missteps, including the possibility of regulatory rejection.

When it comes to your government-funded clinical trial, you won’t find another CRO with more experience working through contract negotiations, compliance issues, reporting requirements, and more.