Full personalized services in clinical studies and medical writing
Med-Clinical is offering Clinical Operations, Regulatory and Medical Writing Services dedicated to medical devices manufacturers
Med-Clinical experts represent a team that includes :
Regulatory & Medical Writer
Biostatistician and Data Manager
Project Manager
Clinical Research Associate
for a tailor-made support in the different stages of your study
OUR MED-CLINICAL TEAM PRESENTATION
Executive Committee
Chief Operating & Commercial Officer
25 years experience in management: clinical development, medical affairs, biometry, health economics, patient engagement, regulatory and manufacturing.
A strong track in managing and leading cross-cultural and cross-functional global teams in complex situations.
Background training in science with extensive management experience at executive level.
Chief Administrative and Finance Officer
Strong Experience in the HR Department and Finance.
Expertise in Marketing and Social Networks
Worked in various sector as Executive Research Company, Industrial, Consulting Services and Pharmaceuticals Companies.
Clinical Team
Project Director and Quality Support
Strong experience in the clinical research organizations: clinical management, data management and global project management.
Risk Based Monitoring strategy
Quality management activities
Operational manager
Management of clinical and data management.
Lead Clinical Research Associate
10 years of experience in healthcare, expertise in clinical research, pharmacovigilance and excellent relationship with the various stakeholders.
CRA for interventional studies and real life studies in different therapeutic areas.
Good Clinical Practices (GCP), Sites selection, Regulatory submission, Monitoring activities.
Biostatistician and Data Junior Manager
Various experiences in biostatistics and data science : prediction, sample size calculation, data analysis, programmation.
End of study internship about prediction on the severity step of asthma in using machine learning and statistics.
M.Sc. data science related to biology in AgroParisTech and M.Sc. Bio-informatics in Paris Saclay University.
Medical Writing Team
Medical Writing Director
Strong experience in medical writing and revision of regulatory documents for submission to notified bodies of more than 40 medical devices:
Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), and Post Market Clinical Follow-Up (PMCF) Plan/Evaluation report according to MDD and MDR requirements, Risk Management (ISO 14971), Usability Engineering (IEC 62366), Quality Management System (ISO 13485).
B.Sc. Biology, M.Sc. Biomedical Engineering, and Ph.D. In Biomedicine at the RWTH Aachen University.
Medical Writer
1.5 years' experience in medical writing and revision of regulatory documents for submission to notified bodies of more than 20 medical devices:
Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), and Post Market Clinical Follow-Up (PMCF) Plan/Evaluation report according to MDD and MDR.
DIU Formation des investigateurs aux essais cliniques des médicaments (FIEC) Paris University and PhD in biophysics and cell biology Strasbourg, France.