Clinical Strategy
Expertly developed end-to-end designs to overcome your toughest clinical program challenges
Small and mid-sized biotechs often engage our clinical strategy A-team in the earliest stages of the drug development lifecycle, taking advantage of Allucent’s consulting expertise to initiate evaluation and strategy dialogue.
Clinical Development Strategy
Our experts develop end-to-end designs of regulatory-compliant clinical programs for a diverse array of product types and indications. Some key components of our clinical development strategy include the following:
Clinical Landscape Analysis
Holistic analysis of the clinical landscape and the investigative product to develop a competitive target product profile and to guide decision-making and fundraising strategies
Clinical Authoring
Authoring of clinical sections of briefing packages, including clinical synopses, to support Health Authority interactions
Regulatory Applications Strategies
Strategic recommendations for clinical content in regulatory applications to best position the benefit/risk ratio of the product
Redesigns and Protocol Amendments Support
Robust approaches to overcome clinical program challenges including redesign options, protocol amendments, responses to Health Authority requests, and clinical holds
Clinical Development Plan
Working collaboratively across functional disciplines, we engage biostatisticians, medical experts, and clinical operational leaders to create a robust clinical development plan for each stage of your product development.
We have proven success across various product types, including small molecules, biologics, vaccines, cell and gene therapies, combination products, devices, diagnostics, and more.
Clinical Protocol Expertise
Our extensive experience, reinforced by team members with experience as senior leaders at various regulatory authorities, including FDA, ensures a deep understanding of regulatory strategy.
Understanding how regulatory strategy and operational procedures interact, our experts help identify any issues or roadblocks and make corrections to expedite the path to approval. The comprehensive expertise of our A-team helps ensure that milestones are met, and regulatory success is achieved.
“The velocity of innovation is increasing, and regulatory and clinical strategy must keep pace. It’s important to build study designs around patients and focus on the practical factors that differentiate a product.”
Sugato De
VP, Regulatory Strategy, Head of Med Tech
Key Clinical Development Strategy Services
- Clinical development plans
- Clinical study reports (CSRs)
- Protocol design and optimization
- Product portfolio strategy
- Product development strategy and planning
- Target Product Profile (TPP)
- Program planning including statistical methods for go/no-go decisions, study design, and selected endpoints
- Regulatory development strategy and submissions
- Clinical pharmacology
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- Due diligence
- Pediatric plans and orphan designations
- Gap analysis, critical risk identification, and contingency planning
- Health Authority meetings
- Safety strategies and risk management
- Pharmacovigilance
Related Content
Additional Resources
Blog
Optimizing Your Clinical Development Plan: Strategies for Biotech Success
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Blog
Mastering Clinical Trial Design: Will FDA’s Latest Guidance on Master Protocols Encourage Increased Adoption?
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Webinar
Pediatric Clinical Trials: Tackling Clinical and Therapeutic Development Challenges Head-On
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