PharmaPro Consulting’s expert biostatisticians with wide industry experience will help you apply statistical and scientific principles to select the optimal study design, randomization, endpoints, sample size, and analyses to accelerate the clinical development program for your compounds.
To author the clinical pharmacology sections for submission to various health authorities (FDA, PMDA, SFDA, EMA, KFDA, etc) which include:
- eCTDs modules 2.7.1 and 2.7.2
- Question-based Reviews (QbR)
- Clinical study protocols
- Clinical study reports
- Investigational New Drug (IND) Applications
- New Drug Applications (NDA)
- Pediatric Investigation Plans (PIP)
- Pediatric Study Plans (PSP)
- Orphan Drug Designation applications (ODD)
- Breakthrough Therapy Designations applications
To address questions relating to Clinical pharmacology, PK, PK/PD, and POPPK from various regulatory agencies across the world.
To develop strategy and execute clinical pharmacology plans, PIP Binding elements, and PSP plans
By serving as clinical pharmacology project leader and provide scientific leadership on Biologics, ADCs and combination therapies, in oncology, immuno-oncology, diseases with unmet medical needs, etc.
Participate in due-diligence and in-licensing activities, Conduct market research analyses and forecast trends
Based on project needs, we can conduct hands-on PK, PK/PD analyses, conduct QC-QR of IBs, CSRs, and health authority submission documents.
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