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
Our Imaging Core Lab Services feature software built to the highest regulatory standards, including CFR 21 Part 11 and ISO 27001:2017 compliance. With advanced capabilities like image transfer encryption, pseudonymization, and an integrated queries module, we make it easy for hospital staff, CROs, and sponsors to quickly access and review the imaging data required for your trial.
By entrusting your imaging and diagnostic data to our experienced, independent team of radiologists and nuclear medicine specialists, you can be confident in the objectivity and quality of the analysis. This centralized approach helps reduce variability across sites and ensures your critical imaging endpoints are evaluated consistently, giving you the reliable data you need to demonstrate the efficacy of your product.
Our user-friendly platform and dedicated support team ensure rapid accessibility and a seamless experience for all stakeholders, prioritizing efficiency and quality at every stage.
