Biography / Cv

PERSONAL INFORMATION

Name: Erica Secchettin

Address: Verona (VR)

Email: erica.secchettin@univr.it

Scopus Author’s ID: https://orcid.org/0000-0001-7924-5577

LinkedIn: https://www.linkedin.com/in/erica-secchettin-149929a1?trk=hp-identity-headline

Gender | Nationality: Woman | Italian

Degree: Pharmacist

Field of Interest: Clinical Trial and Research: Biostatistician, Clinical Project manager, Regulatory Submission, Regulatory Officer, Regulatory affairs

Desired Employment / Occupational Field: Biostatistician, Clinical Project manager, Regulatory affairs

WORK EXPERIENCE

From 2022 – ongoing

Biostatistician and Clinical project manager, Regulatory Officer
Department of Excellence in Surgical Science, Dentistry, Paediatrics and Gynaecology, University of Verona
Competencies and activities:
• Biostatistician and Clinical project manager regarding clinical trial and studies
• Support, guidance and coordination for the submission of clinical trials to Ethics Committee or to Competent Authorities (preparing documents needed for regulatory approval), project development, statistical input to protocol, CRF construction
• Management of step by step trials from submission to real conduction (design, planning, project management – business mgmt, data analysis and dissemination)
• Data Analysis
• Support researchers on application for national and international grants
• Support researchers on writing grants, and papers
• Support researchers on third mission activities and follow fellow’s thesis
• Management of research projects regarding translational, regenerative and robotic surgery and artificial intelligence
• Good knowledge of the Regulatory aspects of product development of medical devices and drugs.
• Good knowledge of biostatistical softwares and online platforms needed to plan, conduct and analyze data (R, Stata, Gpower, REDcap, GanttPro, Covidence, Rayyan)

From 2016 to 2021

Biostatistician and Clinical project manager, Regulatory Officer
General and Pancreatic Surgery Unit, Integrated University Hospital of Verona, Verona, and Anesthesiology and Pain Management Unit, Integrated University Hospital of Verona, Verona
Competencies and activities:
• Biostatistician and Clinical project manager regarding clinical trial and studies
• Support, guidance and coordination for the submission of clinical trials to Ethics Committee or to Competent Authorities (preparing documents needed for regulatory approval), project development, statistical input to protocol, CRF construction
• Management of step by step trials from submission to real conduction (design, planning, project management – business mgmt, data analysis and dissemination)
• Data Analysis
• Support researchers on application for national and international grants
• Support researchers on writing grants, and papers

From 2014 to 2016

Clinical Research Coordinator, Regulatory Officer
Azienda Ospedaliera Universitaria Integrata Verona, Nucleo di ricerca clinica - Unità di supporto alla ricerca e biostatistica (Clinical Trial Unit – Nucleo di Ricerca Clinica AOUI Verona)
Research support for clinical trials: Screening all no profit clinical studies going to the local ethics committee (53 trials: 17 with drugs, 7 with medical device, 29 about surgical techniques; 47 observational projects)
• Coordinating, guiding and assisting all activities before submission to Verona Hospital Ethics Committee (more than 100 projects screened): Site informed Consent Form, localization and guidance in line with regulatory/ health authority requirements, Ethics Committee information, Ethics and governance submission process, Clinical Trial Health Authority application and submission process, contracts & indemnity request process to Broker, other materials and documentation used by the study requiring local governance approval, submission pharmacological trial to AIFA, maintaining up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated regulatory requirements and associated documentation, monitoring clinical trials, data management.
• Support on developing projects from draft to full protocols (about 40 projects).
• Partnership to arrange CRFs
• Monitoring multicenter trial “studio randomizzato controllato multicentrico a bracci paralleli per valutare la non inferiorità della sicurezza di Bevacizumab rispetto a Ranizumab (allocazione 4:1) somministrati per via intravitreale in pazienti con degenerazione maculare senile o altre maculopatie essudative non correlate all’età” EUDRACT: 2013-000133-12
• Monitoring AOUI Verona’s trial (16 trial with device or drugs: audit GCP)
• Pharmacovigilance: Knowledge of new Italian and European legislation of reference for pharmacovigilance activities, for medical devices and drugs.

TEACHING ACTIVITIES

2024 | Advanced course “Data quality in biomedical research” | At Postgraduate Courses, University of Verona, Verona

2024 | Technical webinar in “Clinical Biobanking” | At Surgical Department, University of Verona, Verona

2023 - 2024 | Statistical analysis with R, Basic and Intermediate Course | At Multicourse PhD School, University of Verona, Verona

2022 - 2023 | Statistical analysis with R, Basic and Intermediate Course | At Multicourse PhD School, University of Verona, Verona

2023 | REDCap platform course | At Department of Surgical Sciences, University of Verona, Verona

2022 | REDCap platform course | At Department of Surgical Sciences, University of Verona, Verona

EDUCATION

July 2023: Course of Microsoft Project® - Fondazione Fenice Onlus

June 2023: Course of Project Manager ISIPM-Advanced® - Fondazione Fenice Onlus

From 2023 to 2023: Course of Project Manager ISIPM-Base® - PM certified (ISIPM) - Fondazione Fenice Onlus

From January 2018 – August 2022: Postgraduate School in Health Statistics and Biometrics at Department of Cardio-Thoraco-Vascular Sciences and Public Health, Unit of Biostatistics, Epidemiology and Public Health, University of Padua. Vote: 110 cum laude/110

From 2014 to 2014: Master about Cosmetic Science (II level) - Pavia University, Pavia (Italy). SICC project about facial cleaners. Main tasks: Time keeper (planning project - project management) and support product development (evaluation cost, timing, raw material, providers, stability tests, security, efficacy).

From 2007 to 2013: University of Padua, Pharmacy Degree on 2013.03.11. Vote: 105/110. Thesis at Dipartimento di Ematologia e la Farmacia Ospedaliera dell’Azienda Ospedaliera di Padova. Thesis consisted in a plan for retrospective observational study about patients relapsed and refractory suffered by multiple myeloma treated with lenalidomide. “Cytogenetic Impact on Lenalidomide Treatment in Relapsed/Refractory Multiple Myeloma: A Real-Life Evaluation” - University Hospital of Padua, Padua (Italy)

From 2010 to 2010: Stage at Padua Hospital - University Hospital of Padua - UOC Nephrology - Padua (Italy). Took part at SciClone International’s trial

PERSONAL SKILLS

Mother tongue: Italian

Other Language(s): English (Understanding: B2, Speaking: B2, Writing: B2, Listening: B1, Reading: B2 - Common European Framework of Reference for Languages)

Bibliometric Indexes: (Scopus, as of October 2024) 47 products, citations: 884, H-index: 20

Informatics Competences & Statistical Softwares:
Good Knowledge of internet, e-mail, and Microsoft Office (Word, Excel, Power Point, ACCESS). Good Knowledge of Project management, Management Database PubMed, Scopus, REDCap, Gantt-Pro, OsSCT platform, STATA, Tableau, R, Eudravigilance, Review Manager 5.4, Rayyan, CINeMA, Covidence, Gpower.

Organizational and Job Related Skills:
• Management of scientific projects.
• Excellent team worker, gained through interacting with researchers involved in different disciplines and helping them interacting with each other.
• Help life scientists and physicians to formulate problems in quantitative and formal terms when developing projects (discussions, revising projects, proposing solutions to improve protocols).
• Extensive experience in academy and public health system proving competencies as a regulatory submission specialist and project manager in pharmaceutical files like research and development clinical trials.
• Ability to meet deadlines and work under pressure (acquired when submitting projects every 2 weeks to the Verona Hospital Independent Ethical Committee).
• GCP certification (2019.04.30 NIDA certification).
• Good knowledge of the Regulatory aspects of product development of medical devices and drugs, clinical trial coordination, monitoring, evaluation, and certification.
• Good Knowledge of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) of medicinal Products.

OTHER INFORMATION

Project Principal Investigator / Research Group Participation:
• HAND Project – Experts’ Judgement to support a hybrid Bayesian Network approach to model long-term survival of pancreatic cancer patients at diagnosis (198CET).
• Team Leader of the Project coordination task force, Italian Association for the Study of the Pancreas (AISP)
• Member of the Familial Pancreatic Cancer Task Force, Italian Association for the Study of the Pancreas (AISP)
• Representative for the University of Verona of the Pancreatic Cancer Early Detection Consortium (PRECEDE), USA coordinated by New York University, New York, USA.
• Representative for the University of Verona of the Cancer of the Pancreas Screening Consortium (CAPS), coordinated by Erasmus University, Rotterdam, Holland, and Johns Hopkins University, Baltimore, USA.
• Coordination of an International research group dedicated to develop a new prognostic model at diagnosis able to predict long term survival for patients affected by pancreatic cancer, the “HAND Project”, approved by the local IRB (198CET).

Selected Publications & Research Groups:
Familial pancreatic cancer:
• Paiella S, Secchettin E, et al. Surveillance of Individuals at High Risk of Developing Pancreatic Cancer: A Prevalence Meta-analysis to Estimate the Rate of Low-yield Surgery. Ann Surg. 2024.
• Paiella S et al. Outcomes of a 3-year prospective surveillance in individuals at high-risk of pancreatic cancer, American Journal of Gastroenterology, 2024.
• Archibugi L. et al. The Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC), Familial Cancer, 2024.
• Capurso G. et al. Italian Registry of Families At Risk of Pancreatic Cancer: AISP, Digestive and Liver Disease, 2020.
• Paiella S. et al. Screening/surveillance programs for pancreatic cancer in familial high-risk individuals, Pancreatology 2018.
Celiac disease:
• Zingone F, Secchettin E, et al. Clinical features and psychological impact of celiac disease at diagnosis, Digestive and Liver Disease, 2021.
Pain management and Fibromyalgia:
• Schweiger V et al. Antibodies for migraine prophylaxis: retrospective observational study on 219 patients, Journal of Clinical Medicine, 2024.
• Schweiger V et al. Persistent idiopathic facial pain (PIFP), Journal of Clinical Medicine, 2022.
• Polati E, et al. Oxycodone-naloxone combination hinders opioid consumption, Int. Journal of Environmental Research Public Health, 2022.
• Vittorio, Schweiger, Erica, Secchettin, et al. Comparison between Acupuncture and Nutraceutical Treatment with Migratens®, NUTRIENTS, vol. 12.
• Schweiger, V, Secchettin, E, et al. Quality of life and psychological assessment in patients with Fibromyalgia Syndrome during COVID-19 pandemic in Italy, SIGNA VITAE, vol. 18, 2022.
Cancer nutrition:
• Paiella S, et al. Body composition parameters, immunonutritional indexes, and surgical outcome of pancreatic cancer patients resected after neoadjuvant therapy, Front Nutr. 2023.
• Paiella S, Secchettin E, et al. Evaluation of five nutritional scores as predictors of postoperative outcomes following pancreatic resection, Clinical Nutrition ESPEN, 2024.

Grants Managed / Projects:
• 2020 Intuitive grant: “Cost-effectiveness and Quality of Life of laparoscopic vs. robotic distal pancreatectomy: the Italian Experience”
• 2019-2021 MINSAL Ricerca sul cancro: “Traduzione applicativa dei risultati delle ricerche sul genoma dei tumori del pancreas - Triennio 2019-2021”
• 2019-2021 AIFA Ricerca Indipendente 2018: “Antibiotic stewardship program in pancreatic surgery: a multicenter time series analysis” TRS-2018-00001695
• AdR University of Verona, Department of Surgical Science: “Traduzione applicativa dei risultati delle ricerche sul genoma dei tumori del pancreas” (FIMP / Ministero della Salute) 01/03/2020-20/02/2022
• AdR University of Verona, Department of Surgical Science: “Storia naturale delle neoplasie cistiche del pancreas” 01/03/2016-29/02/2020

Awards, Memberships & Editorial Roles:
• Associate Editor: Frontiers in Public Health / BMC Series
• Memberships: IBIG, SIMeF, AISP, GIDM, SISMEC, AIE, PSI.
• 2023: Research grant from AISP (“Profilazione genetica standardizzata... PROPH-ITA”)
• 2022: Research grant from AISP (“Patologie pancreatiche oncologiche...”)
• 2019: “Premio innovazione e psicologia” Università di Padova

I authorize the processing of my personal data present in my CV pursuant to art. 13 d. lgs. 30 June 2003 n. 196 - “Code in matter of protection of personal data" and of the art. 13 GDPR 679/16 - “European Regulation on the Protection of Personal Data”.

Date: 13/may/2026