1.Planning and Design of Clinical Studies

• Study protocol design : Writing and development of detailed study protocols.
• Study design : Assistance in the methodological design of clinical studies (phases I to IV).
• Regulatory submissions : Preparation and submission of files to ANSM, CPP, CTIS, CNIL and other regulatory authorities.

2. Project Management

• Coordination and supervision : Overall management of the project, including planning, implementation, and monitoring of clinical studies.
• Calendar and budget management : Monitoring deadlines and expenses to ensure deadlines and budgets are met.

3. Site Selection and Management

• Site Selection : Identification and selection of appropriate clinical sites for trials.
• Training and start-up of sites : Organization of installation visits, closing and training of teams on site.
• Surveillance visits : Carrying out follow-up and monitoring visits to ensure compliance and quality assurance of the data collected.

4. Data Management

• Design and management of CRFs and eCRFs : Development of paper and electronic Case Report Form, Analyze research outcomes and publish it.
• ePRO
• CTMS: Clinical Trial Monitoring System
• Data Entry and Management : Coordination of data entry, cleaning and management.
• Statistical analysis : Planning and carrying out statistical analyzes of collected data.

5. Regulatory and Ethical Compliance

• Regulatory Submissions : Preparation and submission of necessary documents to the relevant authorities.
• Management of AE/SAE : Monitoring and reporting of adverse and serious events.
• Quality assurance and audits : Conducting internal audits to ensure compliance with GCP (Good Clinical Practice) and current regulations.

6. Logistics and Materials Management

• Management of supplies and equipment : Coordination of the supply and distribution of supplies and equipment necessary for testing.
• Transport of biological samples : Organization of transport and logistics of biological samples between sites and laboratories.

7. Investigator Support and Training

• Training of clinical teams : Training of investigators and site personnel on study protocols and trial procedures.
• Technical Support : Ongoing assistance to clinical sites to resolve technical and logistical issues.

8. Communication and Stakeholder Management

• Coordination of investigator meetings : Organization of meetings and conferences for investigators.
• Reporting and updating : Regular communication of study progress to sponsors and stakeholders.
• Relationship Management : Maintaining effective relationships with sponsors, clinical sites, and regulatory authorities.

9. Writing and Translation

• Medical writing : Writing study reports, scientific articles, and other necessary documents.
• Translation of documents : Translation of protocols, consent forms and other documents into several languages.

10. Registration and Recording of Trials

• Registry registration : Registration of clinical studies in public databases such as ClinicalTrials.gov.
• Management of consent documents : Preparation and management of informed consent forms.

1. Pharmacovigilance Management

• Adverse event monitoring: Identification, documentation, and analysis of adverse events (AEs) and serious adverse events (SAEs) occurring during clinical trials.
• Safety reporting: Preparation of periodic safety update reports (PSURs) and annual safety reports (DSURs).
• Regulatory reporting: Reporting of AEs/SAEs to health authorities (ANSM, EMA, FDA) in accordance with regulatory requirements.

2. Therapeutic Drug Monitoring and Adherence

• Efficacy monitoring: Monitoring and analysis of the efficacy of treatments administered during clinical trials.
• Adherence management: Development and implementation of strategies to improve patient adherence to treatment protocols.
• Tolerability assessment: Monitoring of side effects and patient tolerance to study drugs.

3. Clinical and Scientific Support

• Clinical team training: Training of investigators and research teams on pharmacovigilance aspects and therapeutic monitoring protocols.
• Scientific consultation: Providing advice and guidance on the biological and pharmacological aspects of clinical studies.
• Scientific writing: Drafting study protocols, study reports, scientific publications, and other medical documents.

4. Data Analysis and Reporting

• Clinical data analysis: Processing and analysis of safety and efficacy data collected during clinical trials.
• Analysis reports: Preparation of detailed reports for sponsors, ethics committees, and regulatory authorities.
• Results communication: Presentation of therapeutic monitoring and pharmacovigilance results to stakeholders.

5. Compliance and Regulatory Conformity

• Compliance: Ensuring that all pharmacovigilance and therapeutic monitoring activities comply with local and international regulations (GCP, ICH, etc.).
• Audit and inspection: Preparation and management of internal audits and inspections by health authorities.

6. Coordination and Project Management

• Project management: Coordination of the various activities related to pharmacovigilance and therapeutic monitoring within clinical trials.
• Interdisciplinary collaboration: Working closely with clinical teams, investigators, sponsors, and regulatory authorities to ensure the success of clinical trials.

7. Risk Management

• Risk assessment: Identification and evaluation of risks associated with the study drugs.
• Risk management plans (RMP): Development and implementation of risk management plans to minimize risks to patients.

8. Education and Awareness

• Educational programs: Development and implementation of educational programs for patients and healthcare professionals on drugs and their use.
• Awareness materials: Creation of educational and awareness materials to inform patients about potential side effects and actions to take.