Alessandra Solferino

Contributed to the development and execution of Phase I/II clinical research study in accordance with regulatory standards, business and departmental procedures. I have worked closely with the research physician and other members of the group to ensure the integrated execution of study initiation activities, study supervision and reporting of clinical trials. Participated in the development of clinical strategy, including participation and presentation in advisory committees. Contributed to the design of the study and the development of related clinical documents (e.g., researcher brochures, study protocol, informed consent forms, eCRFs, study manuals, clinical trial reports, and regulatory presentation documents) Reports to Global Clinical Lead as close collaboration. Presented to the Asset team specific topics on the phase I/II study. Worked closely with medical monitor for regulatory and clinical operations to answer protocol questions from health authorities and ethics committees Attended investigator meetings and hired investigators. Provided updates on the cynical study/project to the Asset team. Worked closely with clinical operations for site startup, site engagement, study recruitment. Worked closely with medical monitor and medical data review to ensure comprehensive medical monitoring, site queries, site problem responses, eligibility questions, and data quality. Worked closely with the pharmacovigilance team in case of problems to ensure the cohesion of SAE databases and AE/laboratory clinics.

Collaborated with physicians and other healthcare professionals to evaluate the effectiveness of treatments and diagnostic techniques.

Improved clinical trial efficiency by streamlining processes and implementing innovative study designs.

Performed data analysis and interpretation of results from clinical trials and epidemiological studies.Drafting of comparative analysis of other studies on the market for pathology. Writing paper.

Participation in the drafting of the research protocols in the definition of the study design Experience in phase 1-4 clinical trials (profit and no-profit), participation of the study initiation visits (SIVs), close out visits (COVs)and interim monitoring visits (IMVs)

Trial Master file quality check

Training to investigators on drug safety

Support to physician in pharmacological part of clinical trials and in medical monitoring of clinical trials

Investigators medical product management and drug accountability responsibility E-case report form (CRF) data entry and query solving

Development of the tools for collecting and measuring databases Collection and interpretation of data

Eligibility, monitoring and toxicity of the CAR-T Serious adverse events management

Pharmacovigilance, Drug surveillance, and information health professionals Use of electronic medical records (W-Hospital, Flower, Galileo, Farmasafe) Use of pharmacological databases (Micromedex, PubMed, Uptodate)

Collaboration to write case report, abstract and papers

Training course Onco-haematological study pharmacological interactions in the Onco- haematological field. Head Prof. Carmelo Carlo-Stella IRCCS Humanitas University Clinical Institute