Paspigioni delivers complete BE study support, from initial protocol and study planning through final analysis and regulatory submission. Our full-service model encompasses site feasibility and selection, CA/EC submissions, clinical study planning, contract setup, eCRF design and validation, site training, electronic data capture (EDC), site monitoring (risk-based, central, on-site, and remote), biostatistical analysis, clinical study report writing, and manuscript preparation for publication. With proven regulatory expertise aligned to EMA BE Guidelines and experience in fixed-dose combination and statin-based studies, we ensure seamless execution and audit-ready compliance throughout the entire study lifecycle.

Paspigioni offers regulatory consulting and protocol development, ethics and competent authority submissions, GLP-certified bioanalysis, clinical conduct under fasting conditions, biostatistics, and CSR preparation, as well as eCTD-ready dossier compilation. We provide comprehensive support for bioequivalence trials, handling all aspects of the study from inception to submission. Our expertise includes thorough alignment with EMA guidelines, biowaiver justification strategies, and proportional formulations within a fully EU submission-oriented framework. Our quality-centric approach features EMA/FDA inspection-ready infrastructure, proactive risk management, real-time QA oversight, and a proven track record of successful regulatory inspections with zero critical findings.

Paspigioni specializes in the strategic identification and qualification of clinical trial sites and Principal Investigators across therapeutic areas. Our comprehensive feasibility process includes site capability assessments, investigator selection, qualification screening, and performance evaluation to ensure dedicated commitment to study success. Through our established network and relationships with top investigators and sites across all covered countries, we guarantee excellence in project execution. We conduct feasibility assessments considering patient population availability, site infrastructure, regulatory timelines, and investigator expertise to select the optimal sites for your trial's success.

We bring extensive expertise in facilitating approvals from government agencies and competent authorities for clinical studies and trials. Our regulatory team manages the complete submission process, including preparation of CA/EC (Competent Authority/Ethics Committee) submission documents, clinical study registration, protocol amendments, and ongoing compliance management. Through streamlined intermediation between your internal regulatory affairs department and health authorities, we simplify regulatory processes, reduce approval timelines, and minimize costs while ensuring full adherence to regional and international requirements, including EMA, FDA, MHRA, and national regulations.

Paspigioni offers dedicated project management with a single point of contact, ensuring transparent communication and accountability throughout your clinical trial. Our experienced project managers oversee the entire study lifecycle from protocol development through final deliverables, including timeline management, milestone tracking, weekly progress updates, risk mitigation strategies, budget oversight, vendor coordination, and stakeholder communication. We ensure efficient execution across all trial phases through consistent communication, reliability, and proactive issue management.

Our CRAs serve as the cornerstone of site interaction, bringing expertise in relationship management, protocol compliance, and GCP standards. We prioritize balanced workloads, assigning CRAs a focused number of protocols and sites to ensure exceptional attention to detail. Our flexible monitoring approaches include risk-based monitoring, central monitoring, on-site monitoring, and remote monitoring. We provide comprehensive site management services, including site training on study documents and eCRF, site initiations, ongoing performance monitoring, investigational site file (ISF) delivery and maintenance, site payment management, and DSMB/CEC coordination, delivering data integrity and strong site partnerships that drive study success.

Executing successful medical device clinical trials demands specialized expertise and tailored strategies. Paspigioni brings extensive experience across medical device classifications (Class I, IIa, IIb, and III), providing comprehensive support throughout the trial process. Our services include protocol development aligned with MDR/IVDR requirements, regulatory submissions and competent authority interactions, notified body liaison, site selection and management, clinical monitoring, risk management documentation, post-market clinical follow-up (PMCF), and preparation of clinical evaluation reports. Our team ensures your device trials meet EU and international regulatory requirements while maintaining efficient timelines and audit-ready documentation.

We provide end-to-end support across all stages of data planning, management, and analysis within clinical trial development. Our  services include:

• Data Management: Clinical data management, EDC system setup and validation (Electronic Data Capture), database design and testing, CDISC implementation, data cleaning and query management, ensuring data integrity from clinic to submission

• Biostatistics: Statistical Analysis Plan (SAP) development, expert biostatistical analysis, statistical programming, interim and final analyses, biostatistical reports for regulatory submissions, Data Monitoring Committee support

• Medical writing support: Clinical study reports, statistical sections of regulatory documents, tables, listings, and figures (TLFs)

Our expert team delivers compliant, audit-ready documentation with seamless execution from data collection through final analysis.

Paspigioni delivers high-quality translation services within tight deadlines to streamline research and authorization processes across multiple languages and regulatory jurisdictions. Our certified translation team handles informed consent forms, patient materials, protocols, regulatory documents, and all study-related documentation with linguistic and cultural accuracy.

Our dedicated logistics team excels in managing clinical supply operations, ensuring the timely delivery of investigational products, ancillary supplies, import/export coordination, temperature-controlled storage and distribution, inventory management, and central lab services. We fulfill regulatory requirements while optimizing development timelines and staying within budget.

We conduct quality control checks and audits on completed studies as well as ongoing trials, whether managed internally or by other parties. Our QA process ensures all studies and documentation meet impeccable standards and are inspection-ready for regulatory authorities at any time. Services include internal audits, pre-inspection readiness assessments, sponsor audits, GCP compliance verification, real-time QA oversight and validated systems, corrective and preventive action (CAPA) management, quality system improvements, and audit preparation. With our proven track record of successful regulatory inspections, we provide EMA/FDA inspection-ready infrastructure and proactive risk control for recruitment, sample handling, and timeline management.

We specialize in developing study protocols, investigator brochures, informed consent forms, clinical study reports, CTD dossier modules (Module 2 and Module 5), regulatory responses, and summary documents. We customize content and language to suit your unique objectives and regulatory targets, ensuring technically accurate, compliant, and compelling documentation. Our pharmacovigilance and medical monitoring expertise includes safety reporting, aggregate safety assessments, periodic safety update reports (PSURs), Risk Management Plan development, and ongoing benefit-risk evaluations. We employ methodologies to detect and interpret safety signals, enabling prompt actions to safeguard patients and trial integrity.