Twenty Years Expertise in a Nutshell

Franziska draws from a broad range of expertise and functional knowledge acquired over two decades in pharmaceutical industry and at academia.

Franziska worked in R&D Clinical Operations for both, sponsor and investigator organisations including 16 years in a leadership position of a dedicated phase 1 unit.

Franziska holds a PhD degree from the University of Basel, Switzerland in analytical pharmaceutical chemistry.

Franziska is also member of RQA (MRQA) and certified fellow in clinical research (ACF) with ARCS (Australia)

Marine Iguana Galapagos

Clinical Trials

Management, conduct and supervision of over 130 clinical studies predominantly phase 1 and 2 for sponsors in the US, Europe, Japan, Korea and China

Comprehensive range of therapeutic areas including oncology

Management of multi-centre studies and sites

Medical writing and study design

Quality and Audits

Management and conduct of sponsor and internal audits

Development and implementation of quality management systems covering all aspects of clinical site operations

SOP development and SOP management systems

GCP, GCLP, cGMP (IMP related), computer system compliance (21CFR11), ISO9001

Regulatory Compliance

Experience with regulatory requirements of various authorities including  TGA, MHRA, EMA, FDA, PMDA, MHLW

Requirements for studies in ethnic subpopulations e.g. bridging studies in north east Asian volunteers and patients

Management of regulatory inspections and pre-inspection readiness

Clinical Site Operations

Phase 1 clinical trial facility and operation set-up, development, management and decommissioning

Provision of support to academic and government organizations in Asia, South America and Australia in developing, expanding and improving their clinical research operations

Leadership and Management

Leadership of cross-functional high performance teams and creation of engaged, supportive and inclusive working environments 

Establishment of strategic and business relationship globally

Teaching and Training

Convenor and tutor in the post-graduate course of Clinical Development of Medicines at the University of NSW

Training and development of clinical research staff in the pharmaceutical industry

Would you like to learn more?

Drop us a line or call us today for a chat.