After more than 17 years of expertise in Clinical Research, Sandrine Kahi founded San.K.Bio Consulting early 2019
In 1999, she successfully graduated from the University of Lyon I (France) with a PhD in Human Biology, with specialization in Immunology.
She joined the clinical research field a couple of years after and started as a Clinical Research Associate in 2002, working for biotech, pharmaceutical companies, as well as academic Sponsors and CROs.
She was promoted Project Manager in 2005 and since that time has been responsible for managing complex and challenging national and international clinical trials. She worked in several therapeutic areas such as infectious diseases (Hepatitis B, HIV), autoimmune diseases (Lupus, Crohn’s disease, Rheumatoid Arthritis), vaccines, and neonatology.
The American Adventure
For the past three years, she has been specifically responsible for opening an ongoing phase IIb international clinical trial in the USA, consequently, she has shared her time between France and Florida. She was in charge of contacting the investigators, performing pre-study visits, following on IRB submissions and supporting the local CRAs on a daily basis. She was also actively involved in the preparation and submission of the IND dossier.
The Quality Assurance Turning Point
During her career, she has worked in close collaboration with Quality Assurance teams, writing SOPs, managing and reviewing CAPAs. Detailed-oriented, she has always had high standards in her work and improved the quality of the projects with which she has been involved. In 2018, she decided to move to Quality Assurance and Auditing.
She was certified as a GCP Auditor by Barnett International in 2018 and has already conducted a few GCP investigational sites and GcLP co-audits.
Her Strengths and Specificities
Her biggest asset is her strong
knowledge of both European and FDA regulations, and the variety of her
experience, as detailed above.
worked in small structures (small biotech and an academic CRO), she had the
opportunity to be involved in every aspects of a clinical study.
extensively for work and currently living between two countries, she is highly
adaptable and flexible.
She is reliable, hard-working and committed to delivering high quality work.
She is fluent in French and English and has an advanced knowledge of Spanish and
Italian. She shares her time between Paris and Miami.
her free time, she loves growing plants and vegetables, practicing yoga,
travelling, hiking, and volunteering for the environmental cause.