Clinical Development Planning
How we help with Clinical Development Planning
Our clinical development experts enhance current development strategies and build new strategies aimed at maximizing your resources. Whether you’re focused on the pathway to the nearest value inflection point or through marketing approval, we will leverage our experience with an assessment of precedence, the competitive landscape, and regulatory guidelines to create the most aggressive, yet feasible, clinical development strategies.
The clinical development plan starts with the end in mind with a target product profile, and will include outlines of key studies, assumptions, risks, timeline, and budget forecasts. We will assess current data packages and development plans to validate assumptions and identify risks and gaps, mitigation strategies, and opportunities to accelerate clinical programs. We build clinical development plans for actionable implementation and, upon request, will defend the plans to our clients’ potential investors and stakeholders.
Our goal is to ensure your product achieves its fullest potential. The plan encompasses:
- Strategic Roadmap
- Regulatory and Compliance Guidance
- Clinical Trial Design Considerations
- Risk Assessment and Mitigation
- Project Management
Read our latest Case StudyClinical Trial Rescue: Leadership Approach to Propel Clinical Development Situation A rare disease biotechnology company’s gene therapy clinical trial was put on hold, and the company found itself with a poor performing Clinical Trial Leader. Rudderless, and without a clear clinical operations strategy, they needed an experienced leader to navigate the […]
Many product developers are propelled by the goal of delivering life-saving treatments as quickly and as safely as possible to patients who are left with no other options. With oncology development, the standard 3+3 dose escalation in study design in first-in-human (FIH) clinical trials is still the standard, however, we should consider alternative Phase 1 […]
Read our latest Case Study Clinical Trial Leadership: Enhancing Efficiencies and Reducing Risk Situation A small biotech developing an innovative therapy needed to retain a clinical trial leader as they were launching their trial at multiple sites. The company experienced two cycles of leadership turnover, resulting in lagging strategy and operations. They needed to immediately […]