clinPKservices.com Information

VISION: provide excellent and rapid PK services and Clinical Pharmacology Lead Services for the Pharma, Biotech, and Medical Device industries in a fraction of a FTE salary. Per-project or retainer services are provided directly to the company or trough CROs. PK SERVICES PROVIDED: • PK analysis - 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. • 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, trough protocol writing, data analysis, to CSR writing. Present PK aspects in Early/Full Development team meetings and governance meetings. CLINICAL PHARMACOLOGY LEAD SERVICES PROVIDED: • Early Development Team leader for pre-Phase 2b assets. Lead 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