Drive your early clinical development

Designing investment-conscious clinical development plans to enable data-informed transition from pre-clinical to clinical studies. Supporting identification of the target population based on pre-clinical data, designing and reviewing patient-centric clinical studies with the cross-functional team, providing input on drug combination optimization.

Timeline optimization from IND to enrollment of first patient. Providing support in the CRO selection. Developing synopsis, protocol, Investigator Brochure and informed consent based on the study design and clinical development plan. Supporting the design of eCRF with an emphasis on clinically relevant data. Site and clinical research associate training.

Optimizing interaction between all stakeholders. Performing a thorough review of safety and efficacy data in ongoing clinical studies. Integrating biomarker and clinical pharmacology data in the overall interpretation of clinical data. Developing clinical trial reports and publications.

Interpretation of pre-clinical and clinical data to understand the value and risks of an early oncology asset from a clinical development perspective. Providing guidance for an early clinical development plan.