Freelance GCP Auditor | Senior CRA

France & USA

“Quality is never an accident. It is always the result of intelligent effort. There must be the will to produce a superior thing" - John Ruskin


We offer Clinical Research Consultancy in France and in the USA

Quality Assurance

We perform GCP audits anywhere in the world, and help you with your audit plan and CAPAs

Monitoring Services

We provide high-quality monitoring
& site management

Study Documents Review

We review thoroughly your study documents,
as well as your CRAs’ visit reports


We perform / review translations of your essential documents from English to French


After more than 17 years of expertise in Clinical Research, Sandrine Kahi founded San.K.Bio Consulting early 2019

The Beginning

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 more than 25 GCP investigational sites 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.

Because she worked in small structures (small biotech and an academic CRO), she had the opportunity to be involved in every aspects of a clinical study.

Having traveled 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.

In her free time, she loves growing plants and vegetables, practicing yoga, travelling, hiking, and volunteering for the environmental cause.

We look forward to working with you!

If you want to contact us or if you have any queries please send us a message at the following address:


We are located in the South of Paris:
76 rue Carvès,
92120 Montrouge,
Phone: +33 6 70 61 49 08

We also operate from Miami, Florida, USA
Phone: +1 551 273 9356