Device Consulting Expertise Meets Clinical Development Excellence

Combining a device and drug can benefit patients by delivering more targeted treatment options, improved drug delivery mechanisms, and enhanced efficacy. While there is a universal need for combination products, regulations are highly variable by country.

Our knowledge of local device regulations, therapeutic expertise, and global clinical operations capabilities enable scalable solutions for all program types and across medical device categories.

We know what to ask up front:

• When should you first engage with regulators?
• What agency divisions do you need to engage with?
• How can you best prepare sites for study execution?
• What about pricing, and ensuring that your device will qualify for separate reimbursement?

Combination Product Study Experience

Premier brings proven expertise in combination product clinical development, with more than 20 drug–device, device–drug, IVD–drug, and biologic–device studies spanning First‑in‑Human through Phase 3. Our diverse portfolio covers high‑growth therapeutic areas—including gene therapy, neurology, oncology, endocrinology, immunology, gastroenterology, cardiology, orthopedics, dermatology, women’s health, and rare diseases—enabling us to anticipate the unique regulatory and operational needs of combination products.

With a global footprint across North America, Asia, India, Israel, and major European regions, Premier delivers consistent execution and regulatory navigation in complex, multi‑country trials.

Our recent experience ranges from infusion‑pump therapies for congenital hyperinsulinism and extended‑release bioabsorbable implants for orthopedic procedures to pump‑based sodium‑removal systems in diuretic‑resistant heart failure. We’ve also supported late‑phase dermatology programs, early‑phase gene therapy studies requiring companion IVDs, and emerging technologies such as Acoustic Cluster Therapy for pancreatic cancer.

Collectively, this depth enables Premier to guide sponsors through the intricacies of drug–device integration, regulatory strategy, and end‑to‑end clinical execution, accelerating timelines and advancing innovative combination products to patients worldwide.

Challenges and Best Practices in Drug–Device Combination Studies

Premier’s cross‑functional structure ensures seamless coordination of all operational elements required to successfully execute combination product trials. This includes investigational device labeling, start‑up specifications, contract and budget negotiations, and tailored project planning such as device‑specific safety reporting and dedicated CRFs to capture performance data.

Our Quality Management System (QMS) is designed to meet both drug and device regulatory requirements and is supported by a comprehensive library of validated templates that streamline documentation and optimize study delivery.

Study Start‑Up: A Proven Advantage

Combination studies often require parallel approvals for device and drug components—an especially challenging process when separate ethics committees review each component, as is common in France and Germany. This can lead to varying document feedback, requiring coordinated amendments and careful timeline management.

Premier mitigates these complexities through a single, unified Study Start‑Up (SSU) department trained across drug, device, and GMO submissions. Unlike larger CROs with siloed business units, our integrated approach allows for:

• Harmonized and complete submission packages
• Streamlined communication and regulatory coordination
• More predictable approval timelines
• Faster and more efficient site activation

Connect with Premier

With deep experience navigating these intricacies, Premier helps ensure accurate submissions, reduced administrative delays, a more efficient path to study initiation, and a smarter path to approval.

Contact Premier today for strategic support with your development program.