Clinical Operations

Conducting a clinical trial in the medical technology industry is overwhelming. From navigating MedTech regulation environment, achieving critical milestones, managing key deliverables, and staying on budget to study design, site selection, investigator training, and more, it can feel impossible to efficiently get your product to market while emphasizing patient impact, quality of life, and economic outcomes.

When you need a specialized partner to seamlessly handle every aspect of your MedTech clinical trial operations, It Takes Avania.

Expert Clinical Trial Management

A purpose-built solution, Clinical Operations deftly manages all phases of your product’s life cycle, from pilot and early feasibility to pivotal and registration as well as post-market study commitments and registries. We help you navigate regional nuances and regulatory requirements, delivering the operational strategy needed to get your product to market.

Our Clinical Operations team is made up of industry-leading project managers, clinical research associates, clinical trial associates, and field clinical specialists, each with an exceptional depth of MedTech knowledge and experience.

Working closely with you, we provide expert oversight and robust project management to optimize data quality, prioritize patient safety, and ensure efficient control of your timelines and deliverables.

Whether you need help with one aspect of your MedTech clinical trial or need end-to-end support, we partner you with a project manager who excels in trial conduct oversight, progress reporting, risk mitigation, budgeting, and more. With a focus on client service and proactive communication, rest assured you will always have complete project visibility when and how you need it.

Integrated MedTech Clinical Trial Solutions

Clinical Operations includes comprehensive clinical trial management services throughout all phases of your MedTech product’s life cycle:

Pilot and early feasibility focused on learning and flexibility
Pivotal and registrational, emphasizing efficacy and effectiveness
Quality of life and health economic outcomes centered around patient impact
Post-market and registries with a spotlight on market intelligence

Our experienced, passionate team will collaborate with you to ensure your trial is conducted according to the study protocol/clinical investigational plan, regulatory requirements, applicable standards, and good clinical practice (GCP) guidelines, safeguarding the rights, safety, and well-being of study participants while prioritizing data quality:

Project management
Investigator identification and site feasibility
Study startup, essential document review, and site activation
Site visits (from qualification through to closeout)
Clinical monitoring — site compliance, data quality, and patient safety investigator and site staff training
Trial master file (TMF) management
Site management
Regulatory compliance, including assistance with ethics applications and competent authority submissions

Our late phase clinical trial management service coordinates the efforts of multidisciplinary teams to gather valuable evidence on the safety, efficacy, and real-world effectiveness of your MedTech product while maximizing communication, visibility, and efficiency:

Project management
Investigator identification and site feasibility
Study startup, essential document review, and site activation
Site visits (from qualification through to close out)
Clinical monitoring
Investigator and site staff training
Trial master file (TMF) management
Site management
Regulatory compliance, including assistance with ethics applications and competent authority submissions

Download Our Clinical Trial Fact Sheet