OUR VISION:

To 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.

OUR SERVICES:

PK ANALYIS & 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, trough 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. 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