Welcome

Dr. A. Garofano Consulting provides Trial/Program management as well as support in all aspects of clinical operation and development. I can support you in running your clinical project in time and within budget. My services include:

Clinical Operation
  • Trial Management
    FIH, Phase I-IV, from start up to CSR
  • CRO-Management
    „Third Party“ selection, qualification, contracting and management
  • Recruitment strategy
    Country/Site selection and qualification, recruitment plan & risk mitigation
  • Mentoring of Clinical Trial Manager/Assistant and Clinical Reasearch Associate
Inspection Readiness
  • Audit preparation & conduct
  • SOP writing
  • Implementation of inspection-relevant processes (like CTP writing and approval, CRO qualification and selection, risk assestment etc.)
  • TMF check
regulatory and clinical Writing

Authoring/Reviewing of CTP, ICF, CSR, submission packages, monitoring plan & other trial related documents

Clinical Development
  • Transition from pre-clinical to clinical phase
  • Building and leading cross-functional teams
  • Support in finalization of the Clinical Development Plan

About

As a Clinical Operation Expert with 20 years of trial and program management experience, I have managed global trials from FIH (proof of concept) to Phase IV, from the startup phase until finalization of the CSR. Furthermore, I have 10 years of experience in the development of innovative therapies and as a line manager.

All trials under my responsibilities reached the recruitment goals and the milestones in time and within budget.



Me in 200 words

Prior to my current role as a freelancer, I held the position of Senior Clinical Operation Program Manager at Affimed, a global biotech company specialized in immuno-oncology. In this role, I assumed full responsibility for all clinical operations activities related to the development of a new drug candidate, successfully transitioning it from the pre-clinical to the clinical phase. I played a pivotal role in finalizing the Clinical Development Plan and was entrusted with leading and overseeing its implementation in the clinical phase.

Furthermore, I have held different roles at Curevac (a global biotech company), mainly in trial and program management, contributing to the development of the mRNA platform in the fields of immuno-oncology and prophylactic vaccines.

I have been employed as Global Clinical Project Manager and as Regulatory Affairs Specialist at two global CROs: SIRO and ERGOMED, in different therapeutic areas.

I hold a PhD in Biochemistry (J. W. Goethe University in Frankfurt, Germany) and a Diploma in Pharmaceutical Chemistry and Technology (University of Padova, Italy).

I continuously update my professional skills by attending training courses in GCP/GDPR, project management, leadership, communication and presentation techniques.

I’m based in Frankfurt a. M. and am business fluent in English, German and Italian.