Clinical

End-to-end clinical trial services for successful clinical research outcomes.

At Eleven Borders, we have over 30 years of experience planning, managing, monitoring and reporting clinical research studies for MedDev products in compliance with ISO 14155, Good Clinical Practice (GCP) and US Investigational Device Exemptions (21 CFR 812). Our experience includes a variety of pre-market investigations required for international regulatory approvals, as well as post-market studies designed for marketing and promotion.

With a network that includes several Clinical Research Organizations (CROs) based in the US, Australia, New Zealand, and Europe, Eleven Borders can assist you in establishing a global clinical strategy that aligns with your regulatory and marketing objectives.

We also prepare clinical evaluation plans and clinical evaluation reports to comply with the Australian Regulations and the EU MDR 2017/745.

We offer a range of clinical research services, including:

• Developing clinical strategies
• Clinical study planning and oversight
• Clinical study project and budget management
• Development of clinical study project plans, protocols, CRFs, Investigator Brochures, patient information, informed consent, study logs, and other study documentation
• Preparation of Ethics / IRB submissions
• Clinical marketing strategies and planning
• Post-market feedback & data analysis
• Scientific Advisory Boards and identification of Key Opinion Leaders (KOLs)
• Preparation of abstracts and manuscripts for presentation at conferences and submission to peer review journals.