Welcome to warren clinical, LLC
Contract and Consulting Services for Drug and Platform Development
I offer targeted, flexible pediatric support from early strategy through launch—aligned with your evolving needs.
Where deeper insights lead to smarter care
Strategic Expertise Across Clinical and Platform Development Needs
Offering tailored support—grounded in deep clinical insight and designed to align with your goals, team dynamics, and the real-world needs of pediatric and young adult patients, families, and users.
Key Areas of Expertise
- Clinical Trial Development: Including: therapeutic landscape analysis, patient pathway, standard of care review, strategic planning, growth & development, psychosocial considerations, pediatric to young adult needs, fertility & sexuality review
- Platform Development: Leveraging extensive clinical experience to inform the development and growth of patient-centered, scalable therapeutic and research platforms
- Cross-functional Collaboration: Work alongside your in-house therapeutic experts and drug or platform development teams to ensure integration and alignment
- Key Opinion Leader Outreach: Engage with KOLs for targeted education, feedback, and insights
- Clinical Education: Deliver accurate, audience-appropriate product education and administration guidance
- Patient & Family Engagement: Educate, connect, and gather feedback from patients, families and advocacy groups
- Recruitment & Retention Optimization: Strategic input to help support patients, families, and your project timelines and milestones
Need other support? Let’s discuss the possibilities
Why Partner with an Expert Strategist?
Expert Contract Support to Strengthen Your Clinical Program
Expert Contract Support to Strengthen Your Clinical Program
Bringing in an expert contract strategist ensures your project benefits from specialized, flexible support rooted in real-world clinical experience. From shaping trial design with deep therapeutic insight to optimizing recruitment and patient engagement strategies, a strategist offers critical, targeted input that complements your in-house teams.
Bridging Clinical Insight and Operational Execution
Expert Contract Support to Strengthen Your Clinical Program
Whether navigating adolescent and young adult (AYA)-specific needs, aligning cross-functional stakeholders, or developing scalable platforms, an expert partner helps bridge clinical relevance with operational execution—accelerating timelines, enhancing impact, and reducing inefficiencies.
Designing Pediatric Trials with Purpose, Not Assumptions
Children are not just small adults—their biology, development, disease presentation, and psychosocial needs differ significantly. Applying adult study designs to pediatric trials can lead to inappropriate dosing, endpoints, or engagement strategies. Pediatric studies require tailored approaches to ensure safety, relevance, and meaningful outcomes for younger patients and their families.
The RACE Act
Informed Strategies Rooted in Experience and Research
The FDA's Research to Accelerate Cures and Equity for Children Act mandates that pediatric trials be considered when a drug’s mechanism of action is relevant to childhood cancers—shifting the focus from disease label to biology. This has made early, strategic pediatric planning essential. Simply adapting adult studies is no longer sufficient; pediatric trials must be purpose-built to meet regulatory expectations and address the unique needs of children and adolescents diagnosed with cancer.
Informed Strategies Rooted in Experience and Research
Informed Strategies Rooted in Experience and Research
Informed Strategies Rooted in Experience and Research
I draw on extensive clinical experience and strategic expertise in drug development, leveraging a wide range of resources—including pediatric and rare disease risk assessment tools, AYA-specific literature, advocacy insights, best practices for clinical trial enrollment, case studies, disease-focused professional organizations, and trial platforms—to inform thoughtful, patient-centered strategies.
Clear Value. No Hidden Costs. Real Results.
Informed Strategies Rooted in Experience and Research
Informed Strategies Rooted in Experience and Research
With transparent pricing and no backend billing surprises, contract services offer a clear, predictable investment. You get expert support exactly when you need it—without the long-term overhead of a full-time hire—making it a flexible and cost-effective solution for growing teams.
Warren—a network of interconnecting rabbit burrows. The ‘rabbit hole’ refers to a complex situation that draws one into deeper, often unexpected, levels of exploration or involvement.