XPER Research provides flexible clinical research solutions tailored to the specific needs of medtech companies worldwide.
Our expert team offers comprehensive support, from consultancy to full project support, ensuring efficient execution and high-quality outcomes.
Comprehensive project management across all trial phases, efficient study startup, end-to-end site management including site identification, qualification, selection, initiation, monitoring and close-out as well as full trial documentation management (TMF).
Data management, randomization and blinding, eCRF design, advanced biostatistics including sample size calculations, statistical analysis plan (SAP), interim analysis and final TLFs.
Strategic navigation of regulatory pathways, Ethics Committee and Competent Authority submissions as well as clinical strategy development and expert regulatory consulting.
Accurate safety reporting to all required regulators, adverse event coding and narratives preparation, medical monitoring, data safety monitoring boards (DSMB) and clinical events committees (CEC).
Specialized in medical devices, we focus on what matters: clear, to the point documentation that meets regulatory standards without unnecessary complexity.
Patient and HCP engagement are the cornerstone in each study design enabling successful study enrolment and execution. Usability and human factor studies are a regulatory requirement focusing on the correct use and continued improvement of the medical device.
At XPER Research, we bring our clinical research expertise to clients worldwide, ensuring seamless support across borders and time zones. Our tailored approach means that, wherever your study takes place, you’ll receive the same dedicated guidance, regulatory insight, and operational excellence we’re known for. With a network spanning continents, we combine local knowledge with global standards, helping you advance your research with confidence—no matter the location.
Our team specializes in medical devices and in vitro diagnostics, ensuring compliance with ICH-GCP, ISO 14155, MDR and other applicable standards. We support all phases of clinical trials, from Proof of Concept to Post-Market Surveillance.
Guided by a pragmatic, efficiency-driven philosophy, XPER delivers high-quality results on time and within budget, helping you move forward with confidence.