Dr. Antonio Steardo, a pharmacologist with extensive experience in clinical trial design and methodological evaluation, supports professionals and institutions in preparing robust, ethical, and regulatory-compliant research protocols. Thanks to his expertise in methodology, statistics, governance, and data management, he offers comprehensive support for developing reliable and reproducible therapeutic studies, minimizing operational risks and enhancing scientific quality.
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Methodological issues in study design
Analysis of the most common pitfalls in clinical trial design, such as bias, low statistical power, inadequate inclusion criteria, or inconsistent methodological choices. Understanding these aspects allows for the construction of more robust and reliable studies.
Methods and clinical protocol creation
Knowledge of the methods required to develop comprehensive protocols: defining objectives, choosing the study design, selecting endpoints, planning analyses, and defining safety criteria.
Internal trial governance
Identification and management of internal organizational challenges, such as workflows, operational responsibilities, role management, and coordination among the various stakeholders involved in the study.
Statistical issues and their management
Understanding key statistical challenges—sample size, variability, power, Type I and Type II errors—and strategies to effectively address them during protocol design.
Ethical issues in clinical trials
Introduction to the ethical principles of research: informed consent, participant protection, risk minimization, transparency, and ethics committee oversight. Essential for ensuring compliant and responsible studies.
Data management in clinical trials
Knowledge of procedures for collecting, storing, protecting, and analyzing clinical data. Includes the implementation of data management systems compliant with quality standards and privacy regulations.
External trial governance
Understanding interactions with regulatory bodies, sponsors, ethics committees, and monitoring organizations. Essential for ensuring that the study complies with all international regulations and standards.
Stakeholder management
Effective coordination of all figures involved: data managers, study coordinators, research nurses, ethics committees, and sponsors. Proper management ensures operational fluidity and data quality.