CLINICAL RESEARCH CONSULTANT

Catherine Bosc

About me

I am a senior clinical research specialist with 25 year experience in interventional and non-interventional researches in an international environment.
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Tailorpharma

cbosc@tailorpharma.com
Background
Prior to founding my consultancy company, Tailorpharma, I have gained experience in research for 13 years, at different positions in pharmaceutical companies. I have worked on drugs and medical devices.
I was in Galderma R&D Corporate for 3 years as a Clinical Project Manager in the Medical Affairs Department. I was in charge of projects worldwide, phase I to IV, support to products life cycle management.
Before, I spent 3 years in Sanofi Pasteur MSD Corporate as a Clinical Operations Coordinator managing European clinical trials, phase III to IV, commitments to post marketing authorization and supporting variations.
Eventually, I also spent 6 years, 4 of which in Bristol Myers Squibb, as a Clinical Research Associate. I was managing local Investigative sites in oncology, cardiovascular diseases, psychiatry and immunology.

An unique approach for developing CRA skills

Lead and training of CRA using an innovative method aimed at developing the operational skills of junior and senior CRAs through work situations recreated in a virtual monitoring environment.

Personalized training tailored to the skills the CRA need to practice .

Education & Experience

  • Education

    • Master in Pharmacology - 2000

      FACULTY OF SCIENCES NICE

      Research degree in Pharmacology

  • Experience

    • LCRA

      CRA team management, CRA QC visits, mentoring of junior CRA

    • SITE MANAGEMENT

      Site feasibility and recruitment, contracts with institution, monitoring from site initiation to closure. Area of expertise: France.

    • PROJECT MANAGEMENT

      Project & team’s management and lead. Budget and timelines.

      Areas of expertise: Interventional and non-interventional studies, CRO and Sponsor environment.

Education & Experience

 

– Education

Master in Pharmacology – 2000

FACULTY OF SCIENCES NICE

Research degree in Pharmacology

 

– Experience

 

PROJECT MANAGEMENT

Project & team’s management and lead. Budget and timelines.

Areas of expertise: Interventional and non-interventional studies, CRO and Sponsor environment.

 

REGULATORY

Submission packages to Competent Authorities, Ethics and Data Privacy body. Areas of expertise: France – United Kingdom .

 

LCRA

CRA team management, CRA QC visits, mentoring of junior CRA

 

SITE MANAGEMENT

Site feasibility and recruitment, contracts with institution, monitoring from site initiation to closure. Area of expertise: France.

Project & Mission involvement

 
CRA Trainer
 CRA’s support and development
LCRA
 Hematology (phase 2), biotechnology company
8 CRA across 4 EU countries, CTIS submission, investigational site’s contract, vendors management, study documents and study plans review

 

Clinical Trial Manager
Hematology (phase 2), biotechnology company
CTIS submission, investigational site’s contract, LCRA activities (8 CRA across 4 EU countries), vendors management, study documents and study plans review
CRA Trainer

CRA’s support and development

CRA

Hematology (phase 1/2 Central Nervous System Lymphoma), biotechnology company
France 4 sites: initiation, site management and monitoring

Lung Cancer (Non-Small Cell Lung Cancer) phase 1/2, biotechnology company
France 3 sites: initiation, site management and monitoring

 

CRA Trainer
CRA’s support and development
CRA
Hematology (phase 1/2 Leukemia, Myelodysplastic syndrome), biotechnology company France 3 sites: initiation, site management and monitoring
 
Lung Cancer (Non-Small Cell Lung Cancer) phase 1, biotechnology company
France 3 sites: initiation, site management and monitoring
 
Hematology (phase 1/2 Central Nervous System Lymphoma), biotechnology company
France 4 sites: initiation, site management and monitoring
 
Ovarian Cancer (Low-Grade Serous Ovarian Cancer) phase 3, biotechnology company
France 6 sites: initiation, site management and monitoring
Clinical Trial Manager
 Ophthalmology (phase 3), pharmaceutical company 20 sites, 360 patients: vendors management, submission packages review, study documents and study plans review, CRA team management (10 CRA across 5 EU countries)
Lead CRA
 Oncology and Hematology (phase 3 DLBCL, phase 1 ovarian and uterus cancer), biotechnology company LCRA activities 21 CRA across 11 EU countries, support to Project Lead, assessment of CRA
Project Manager
 Ophthalmology (clinical investigation medical device), medical device and pharmaceutical company 6 sites, 100 patients: protocol and study documents development
Lead CRA
 Oncology and Hematology (phase 3 DLBCL, phase 1 ovarian and uterus cancer), biotechnology company LCRA activities 21 CRA across 11 EU countries, support to Project Lead, assessment of CRA
Study Start Up Specialist
 France Phase 3: amendments submission to ethics committee France Phase 1: study initial submission to ethics committee, Data privacy, site contracts including CNOM. France Medical Device clinical investigation: initial submission ethics committee and competent authority
Medical writer
 Ophthalmology (clinical survey): poster and manuscript development
Project Manager
Ophthalmology (clinical survey), medical device and pharmaceutical company
100 sites, 3500 patients: protocol and study documents development, regulatory package (data privacy), project daily management
Lead CRA

Oncology and Hematology (phase 3 DLBCL, phase 2 colorectal cancer), biotechnology company

LCRA activities 21 CRA across 11 EU countries, support to Project Lead, assessment of CRA

Study Start Up Specialist
France Phase 2 study initial submission and amendments: ethics committee, Data privacy, site contracts including CNOM.Phase 3: site contracts including CNOM.
 France Phase 1 study initial submission and amendments: ethics committee, Data privacy, site contracts including CNOM. 
CRA

Oncology (phase 2 colorectal cancer), biotechnology company

France 5 sites: site initiation and monitoring

Hematology (phase 3 DLBCL), biotechnology company

France 8 sites: site initiation and monitoring

 

Oncology (phase 1 bladder cancer), biotechnology company

France 1 site: site initiation

 
Project Manager
 Cardiology (observational global study, rare disease), academic society 40 countries Europe, 130 sites, 1.000 subjects: protocol development, start-up activities, and project conduct up to report and publication. Cardiology (observational prospective study), academic society 70 countries worldwide, 360 sites, 10.000 subjects: protocol development, start-up activities and project conduct up to report and publication.
Orthopedics (observational study medical device), medical device company 2 sites, 60 subjects, France: protocol development, start-up activities and project conduct up to report
Study Start Up Specialist
 France, observational study initial submission and amendment: ethics committee, French Data privacy, Notification to ANSM, site contracts including CNOM. UK observational study initial submission and amendment: ethics committee, HRA, site contracts, UK portfolio adoption
Phase 2 study initial submission and amendments: French ethics committee, French Data privacy, site contracts including CNOM.
CRA
 Neurology (phase 3 insomnia), international CRO France 3 sites: monitoring and site closure Oncology (phase 2 colorectal cancer), biotechnology company France 5 sites: site initiation and monitoring Hematology (phase 3 DLBCL), biotechnology company France 14 sites: site selection
Project Manager
 Cardiology (observational global study, rare disease), academic society 40 countries Europe, 130 sites, 1.000 subjects: protocol development, start-up activities, and project conduct up to report and publication. Cardiology (observational prospective study), academic society 70 countries worldwide, 360 sites, 10.000 subjects: protocol development, start-up activities and project conduct up to report and publication.
Study Start Up Specialist
 France, phase 1 and phase 3 studies, initial submission to ethics committee France, observational study initial submission and amendment: ethics committee, French Data privacy, Notification to ANSM, site contracts including CNOM. UK observational study initial submission and amendment: ethics committee, HRA, site contracts, NIHR UK portfolio adoption
CRA
 Neurology (phase 3 insomnia), international CRO France 3 sites: monitoring
Project Manager
Cardiology (observational global study, rare disease), academic society
40 countries Europe, 130 sites, 1.000 subjects: protocol development, start-up activities, and project conduct up to report and publication.
Cardiology (observational prospective study), academic society
70 countries worldwide, 360 sites, 10.000 subjects: protocol development, start-up activities and project conduct up to report and publication.
Orthopedics (clinical investigation medical device), medical device company
2 sites, 100 subjects: protocol development, start-up activities and project conduct up to report
Ophthalmology (observational prospective study), medical device and pharmaceutical company
4 sites, 60 subjects: protocol development, start-up activities (site selection, contract, submissions for authorization) and project conduct
Study Start Up Specialist
 UK Phase 3 initial submission: ethics committee, HRA, competent authorities, site contracts UK, NIHR portfolio adoption Germany Phase 3 initial submission ethics committees France Phase 3 and medical device initial submissions: ethics committee, French Data privacy, site contracts including CNOM. Belgium Medical device initial submissions Ethics Committees
CRA
 Neurology (phase 3 insomnia), international CRO France 3 sites: site selection, monitoring Neurology (phase 3 ICU), international CRO France 10 sites: site selection Cardiology (phase 3, HTA) France 8 sites: site selection
Medical writer
 Clinical Evaluation Reports (orthopedic medical devices)
Project Manager
Orthopedics (clinical investigation medical device), medical device company
2 sites, 100 subjects: protocol development, start-up activities and project conduct up to report
Food supplement (clinical study, diabetes) food supplement company
10 sites, 80 subjects: protocol development and project conduct.
Ophthalmology (market survey), pharmaceutical company
4 sites, 1000 patients, protocol questionnaire, authorization (data privacy), conduct, data analysis, poster and publication
Ophthalmology (clinical investigation medical device), medical device and pharmaceutical company
3 sites, 50 subjects: protocol development and project conduct up to report
Study Start Up Specialist
France food supplement and medical device: submission ethics committee, competent authorities, French Data privacy, site contracts including CNOM.
UK
Medical device initial submission: ethics committee, HRA, and competent authorities
Germany
Phase 3 initial submission ethics committees
Medical writer
 Clinical Evaluation Reports (orthopedic medical devices) Expert scientific report: cosmetic ingredient, pre-clinical and clinical data
Market survey, ophthalmology: communication (paper accepted in Journal Français d’Ophtalmologie Sep. 2017, oral communication for KOL at Société Française d’Ophtalmologie May 2016 and poster) Development of pediatric consents
Project Manager
 Ophthalmology (clinical investigation medical device), medical device and pharmaceutical company 3 sites, 50 subjects: protocol development and project conduct up to report Orthopedics (clinical investigation medical device prothesis), medical device company 6 sites, 200 subjects: protocol development and project conduct up to report
Ophthalmology (market survey), pharmaceutical company Protocol questionnaire, authorization (data privacy), conduct, data analysis, poster and publication
CRA
 Oncology (phase 2 head neck cancer) international CRO 3 sites, France: monitoring Hematology (phase 2), international CRO 5 sites, France: site selection Immunology (phase 2), international CRO 4 sites, France: site selection Rheumatology (phase 3), international CRO 5 sites, France: site selection
Regulatory consultant
 External consultant for French Competent Authorities (ANSM)
Study Start Up Specialist
 France Phase 2 initial submission ethics committee and competent authorities, French Data privacy, site contracts including CNOM. UK Phase 2 initial submission ethics committee, HRA and competent authorities
Scientific communication
 Expert board, medical device: data analysis, presentation development
Project Manager
 Ophthalmology (clinical study medical device), medical device and pharmaceutical company 3 sites, 50 subjects: protocol development and project conduct up to report Orthopedics (clinical study medical device prothesis), medical device company 6 sites, 200 subjects: protocol development and project conduct up to report
CRA
 Oncology (phase 2 head neck cancer) international CRO 3 sites, France: monitoring
Study Start Up Specialist
 Germany Observational study initial submission ethics committee. UK Observational study initial submission ethics committee. HRA France Phase 1 initial submission ethics committee and competent authorities Belgium Phase 1 initial submission ethics committee and competent authorities
Regulatory consultant
 External consultant for French Competent Authorities (ANSM)
CRA
Oncology (phase 2 colorectal cancer), biotechnology company
France 3 sites: monitoring
Orthopedics (non-interventional study), medical device company
France 2 sites: site management and monitoring
Study Start Up Specialist
 France Medical device and phase 4 pass studies initial submission ethics committee and competent authorities UK Phase 4 pass study initial submission ethics committee, HRA and competent authorities Italy Phase 4 pass study initial submission ethics committees
Scientific communication
 Expert board, medical device, prosthesis: data analysis, presentation development Expert board, drug, vaccines: support development, minutes and follow up.
CRA
 Oncology (phase 2 colorectal cancer), biotechnology company France 3 sites: monitoring Orthopedics (non-interventional study), medical device company France 2 sites: site management and monitoring
Learning
 Pharmaceutical company: development of training supports for standard operating procedures Clinical regulation intelligence: training of clinical team on updated trial regulation in France.

Contact

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