Expert consulting from FIH to filing and beyond
Our Vision
To provide excellent and rapid PK services and Clinical Pharmacology Lead Services for the Pharma, Biotech, and Medical Device industries at a fraction of an FTE salary. Per-project or retainer services are provided directly to the company or through CROs.
Our SERVICES:
PK ANALYSIS & PHARMACOMETRICS SERVICES
- PK analysis - conducting non-compartmental analysis (required for all Phase-I/II studies), compartmental and population PK and PK/PD analysis using the gold standard software. Data interpretation for CSR and as rapid-turnaround for dose escalation decisions.
- Serve as the client interface with PMX vendors - supporting the client with all the required interactions with PMX vendors: vendor selection process, analysis plan development, review and provide feedback during the model development and simulation process, critical review of PMX report and writing the Discussion section.
- First in Human (FIH/FIM) dose selection – integrating pharmacology, toxicology, in-vitro, and animal model data (internal and competitor information) to come up with an agile dose escalation scheme
- Full PK support – serve as a protocol PK scientist from the study design concept, through protocol writing, data analysis, to CSR writing. Present PK aspects in Early/Full Development team meetings and governance meetings
CLINICAL PHARMACOLOGY LEAD SERVICES
- Early Development Team leader for pre-Phase 2b assets. Leading cross-functional development teams with responsibilities to develop and execute the Clinical Pharmacology plans (CDP).
- Study Director for required Ph-I/II studies - in charge of all scientific and operational aspects of the clinical study
- Consulting in preparations and representation for regulatory interactions: regulatory document preparation (briefing books, NDA and sNDA Biopharmaceutics and Clinical Pharmacology Summaries), participation in face-to-face and teleconference meetings with regulators and in preparing responses to Health Authority written questions
ADDITIONAL SERVICES
- Lectures and courses
- Compound/ pipeline evaluation for financial purposes (due diligence, VC investments)
- Connecting, building an asset file, and representing biotech/ small pharma companies to the relevant people/ departments in large pharma companies
Magic Wand Research - Clinical Services
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