Study planning and set up
We study your product’s scientific and practical background, intended use, indication and population, the regulatory environment as well as your intentions and resources, all in order to appropriately design your study.
We believe that this is the basis for an excellent clinical trial protocol and study execution.
Study start up, document preparation
We have a vast knowledge of the most updated clinical study regulations. We follow our SOPs and all relevant regulations in order to promise appropriate content and comprehensive documents that are in line with the requirements and study needs.
We professionally develop all the needed core documents i.e.: Protocol, ICF, IFU, IB etc
Study Feasibility and Sites selection
Following a thorough understanding of your study characteristics and needs, we reach out to our network of sites in order to find the right sites and Investigators for successful and smooth study execution.
Regulatory submissions and contracts
We plan and complete the submission package according to the local regulatory requirements, communicate with the Ethics Committees and Regulatory Authorities to obtain all required approvals. We negotiate financial contracts to full execution.
Site management and Clinical Monitoring
We build strong relations with the site staff for optimal cooperation. We devise a source document verification (SDV) strategy to monitor data validity, ensure that protocol and regulations are followed, and subject’s safety and rights are respected.
Data management and Biostatistics
We are responsible for the quality of your data, we develop the case report form (CRF), data management plans and guidelines, electronic data capture (eDC) setup, design, verification and validation. Manage interim analysis, database locks, biostatistics until final report.
Project management and Overview
We manage your project in close collaboration and partnership with all parties and vendors, in relation to: timelines, milestones, training materials, sites support, in house monitoring, open action follow-up, eTMF, Clinical study plans, CMP & SOP. All in order to ensure high level of standards and quality of study conduct.
Interim and final study reports
From early stages of the study, we consider the expected outcome needed for the final study report and give high importance to report writing as the final document summarizing the entire operation and results. We perform this diligently and professionally according to high industry standards.