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Clinical Development
Clinical and Product Development Strategy and Services to Support Regulatory Success for Novel Treatments
Our Clinical Development partners consist of industry and FDA professionals and collaborators with a global reach, experienced across:
- Therapeutic and Preventive Vaccines
- Small Molecules
- Combination Products
- Biomarker Development
- Cell, Gene and Tissue Therapies
- Companion Diagnostics
Our Services
- Product development plans and regulatory strategy
- Design and authoring of expedited (fast track, orphan) pathway requests
- Experience with RMAT designation
- Design and authoring of the Target Product Profile (TPP) including endpoint strategy
- Clinical trial strategy
- Design and authoring of Phase 1-4 Clinical Study Protocols
- Biostatistics support including design of analyses and Statistical Analysis Plan (SAP) writing and review
- Medical writing for regulatory and clinical study documents from pre-IND to NDA/BLA
- Support in all aspects of marketing applications, including writing, review and editing; expertise in safety narratives
- Preparation for and attendance at FDA meetings including mock clinical data reviews
- Clinical Pharmacology
- Safety Monitoring
- Product Labeling
- Measurement science including Clinical Outcome Assessments (COAs) and Patient-Reported Outcomes (PROs)
- Landscape assessment and due diligence support
Our Difference
Global Network
Former FDA Industry experts with CMO experience
Broad therapeutic area expertise
Book a Consultantion with an Expert
Do you need more information about our services? We would love to hear from you!