A successful clinical investigation requires a solid strategy, sound study design and complete documentation.
We build regulation-compliant, cost-effective and operationally feasible roadmaps based on your device class, intended purpose and risk profile.
Defining the right clinical strategy directly impacts study design accuracy, budget efficiency and the strength of clinical evidence. We support this through structured research synopses and joint strategy meetings with sponsors and investigators to finalize the optimal study design.
Clinical Investigation / Performance Study Protocol (CIP/CPSP)
We prepare ISO 14155 / ISO 20916–compliant protocols with clear endpoints, methodological rigor and audit-ready structure.
Investigator’s Brochure (IB)
We develop comprehensive IBs compiling all clinical, preclinical and biocompatibility data in a coherent, consistent and fully traceable format.
CRF & eCRF Design
We design protocol-aligned, user-friendly, traceable and fully auditable data collection tools.
We create CRF/eCRF structures that guarantee data quality, traceability and reliable, ensuring consistent, standardized and error-resistant data capture.
Our goal: high-quality data, minimal error and audit-ready datasets.
Informed Consent Form (ICF)
Ethically sound, clear and country-specific consent forms that support subject safety and regulatory compliance.
Trial Master File (TMF) Setup & Maintenance
We establish, structure and maintain an audit-ready TMF containing all essential documents required to demonstrate how the study was planned, conducted and monitored—ensuring document integrity and regulatory compliance.
Multilingual Translation of Clinical Documents
We provide medically accurate translations (ICF, IB, Protocol, etc.) aligned with country-specific submission requirements through our certified medical translation partners.