Clinical Proof of Concept
The Aptiv Solutions Early Phase Product Strategy team provides comprehensive expertise in strategic clinical drug development and its implementation. This includes design and guidance throughout the clinical development process from early phase development to first in human (FIH) through to NDA and post marketing.
Our specialists have gained their experience by working in mid and large pharmaceutical companies, small biotechnology companies and clinical research organizations. We have harnessed this experience and use it to create development programs that are intelligently designed, cost-effective and timely while taking into consideration the practicalities of implementation.
We offer an array of early phase clinical services:
- Transitional/clinical strategy and general investigational plan development
- Selection of target indications and patient population
- Dose selection and FIH safety
- Target effect/proof of concept and go vs. no-go decisions on programs
- Study and protocol design and preparation for all phases of clinical development including:
- First in Human studies to peri-approval, including proof of concept, proof or principal, and pivotal studies with specialist design
- Single arm, multiple-arm, randomization studies with factorial design
- Healthy volunteer and special population studies
- Adaptive trial designs with appropriate early stopping rules
- Targeted therapy trials, including gene therapy and biomarker/translational research
- Clinical advisory expertise in interactions with regulatory agencies from initial indication and to support label extension
