We specialize in the careful selection of Principal Investigators and key opinion leaders within each therapeutic area, ensuring their dedication to our studies. Our established relationships with these Investigators instill confidence in our ability to achieve success in every project we undertake, as they serve as our primary advocates and prescribers. Through these trusted connections, we guarantee a commitment to excellence and the advancement of medical research.

We bring extensive expertise in facilitating the intermediation process between your internal regulatory affairs department and government agencies and competent authorities to secure approvals for various studies and trials. Our streamlined approach simplifies the entire process, leading to cost reductions associated with these activities.

Paspigioni provides a comprehensive, streamlined management solution designed to address challenges, facilitating enhanced study timelines, and maximizing sample integrity and utilization. Through our proven expertise in clinical trial management across diverse therapeutic domains and trial scales, we offer a unified platform. Our team of specialists collaborates closely with you to tailor our array of services to suit your unique sample management requirements.

Our CRAs serve as the cornerstone of interaction with clinical sites, boasting expertise in relationship management. We prioritize a balanced workload for our CRAs, ensuring they are assigned a limited number of protocols and sites. This focus allows us to deliver:

• High-caliber data integrity

• In-depth attention to and understanding of your program

• Strong partnerships with clinical sites

Executing successful medical device clinical trials demands specialized expertise and a tailored strategy. Paspigioni brings extensive experience across various medical device classifications, ensuring comprehensive support throughout the trial process.

We specialize in support across all stages of data planning and management within the clinical trial development process, including statistical analysis for generating final study and statistic reports. Our services encompass:

• Medical Writing: study protocols, investigator brochures, informed consent forms, clinical study reports, CTD dossier modules, and scientific articles;

• Expert Biostatistics;

• Statistical Programming;

• Data Monitoring Committee;

• Clinical Data Management;

• CDISC Implementation.

We specialize in delivering high-qualityi translation services within tight deadlines to streamline your research and authorization processes. Our dedicated team excels in efficiently managing clinical supply logistics, ensuring timely delivery of clinical trial supplies, ancillary supplies, and central lab services, all while staying within your budget. With our comprehensive suite of services, Paspigioni empowers both emerging and established life sciences companies to fulfill regulatory requirements, optimize drug development outcomes, and enhance product value.

We review and conduct thorough quality control checks on completed studies as well as those being undertaken by other parties. Our rigorous process ensures that all studies and accompanying documentation meet impeccable standards, ready to withstand scrutiny from regulatory authorities at any time.

At Paspigioni, our medical writing team adept the vast landscape of medical disciplines. We specialize in crafting intricate scientific documents tailored to facilitate the advancement of your pharmaceutical drugs through clinical development, registration, and marketing processes. With a keen focus on both content and language, we customize scientific materials to suit your unique objectives and targets. In the realm of medical monitoring, we employ rigorous methodologies to swiftly detect and interpret signals within safety data. Our goal is to pinpoint potential issues early on, enabling prompt and precise actions to safeguard both patients and trial integrity. Trust Paspigioni for comprehensive medical writing and vigilant medical monitoring services tailored to your specific needs.