EFS and FIH Studies

First-in-human (FIH) studies and early feasibility studies (EFS) provide valuable data to consolidate your pre-clinical testing and product development, and, most importantly, serve as the foundation for your pivotal studies to maximize regulatory approvals.

When you need MedTech product development specialization and multidisciplinary clinical trial expertise to put your EFS and FIH studies on the path to success, It Takes Avania.

Thorough EFS & FIH Study Support

We have a track record of successful partnerships on challenging studies, offering regulatory and clinical support to deliver product readiness.

Our EFS and FIH services include:

Engaging early in product development (at the concept phase)
Refining device design and/or instructions to best align with user requirements
Offering strategic guidance on study design to assess product performance, safety, and patient outcomes
Supporting identification and engagement of the skilled physicians and high-quality sites necessary for EFS and FIH studies
Navigating regional regulatory requirements for clinical studies
Analyzing and presenting key data used to determine the next phases of product development
Granular options for concurrent program design execution including product design, risk management, regulatory, and clinical development
And more

The First-in-Human and Early Feasibility Experts

With our mastery of MedTech and deep experience conducting EFS and FIH trials both globally and regionally, Avania is the ideal partner for your development program.

Our team features recognized thought leaders in FIH and EFS-IDE (Investigational Device Exemption) trial best practices who seamlessly engage with you in proactive, transparent review, triage of key risks, and decision-making. Additional interdepartmental teams collaborate to support all aspects of your study, from design through commercialization and beyond, while our unwavering focus on early patient experience, product iteration, and regulatory positioning put you on the path to success.

Premiere Australian FIH Study Services

Australia is a global leader in FIH clinical trials, offering a unique combination of benefits that streamline processes, reduce costs, and deliver world-class outcomes.

Avania is proud to offer comprehensive FIH study services in Australia so you can take advantage of benefits including:

One of the most compelling reasons to conduct FIH trials in Australia is its R&D Tax Incentive program. Eligible companies can reclaim up to 43.5% of their clinical trial costs, significantly lowering the financial burden and increasing return on investment. This program supports innovation while providing a cost-effective path to advancing your research.

Australia boasts state-of-the-art healthcare facilities and cutting-edge technology. From advanced laboratories to well-equipped clinical trial sites, your studies will be supported by exceptional infrastructure. Whether conducted in public or private hospitals, trial participants benefit from the highest standards of care, contributing to reliable and high-quality trial outcomes.

Australia’s regulatory environment is designed to accelerate FIH studies. The Therapeutic Goods Administration (TGA) operates under a simplified Clinical Trial Notification (CTN) scheme, avoiding the need for formal IDE approval. Ethics submissions are reviewed rapidly, with timelines averaging 4-6 weeks and as little as 2 weeks for streamlined studies. This harmonized, transparent process ensures quick trial initiation, saving you valuable time.

Australia’s clinical trial landscape thrives on collaboration. Public and private hospitals work seamlessly together to deliver high-quality results, and, most importantly, offer optimal patient care in a cost- and time-effective manner. Avania further prioritizes open communication, fostering strong partnerships with investigators, sponsors, and trial sites. This collaborative environment ensures:

Efficient problem-solving and issue mitigation
Enhanced recruitment initiatives driven by site engagement
Transparent and effective communication across all stakeholders