75 trials in the last 4 years
We contribute to innovation through the support of clinical trials, including 75
trials in the last 4
years.
Development Solutions
Using our 40+ years of nuclear and precision expertise, we help innovators navigate the complexities of bringing radiopharmaceuticals to market.
Cardinal Health is your expert manufacturer and pharmacy for clinical trials
The earlier you engage us, the better, so we can provide expert guidance on the most efficient & cost-effective process for manufacturing and dispensing patient-specific doses in the United States.
Through expert guidance and well-established processes we help you:
- Ensure consistent quality for clinical trial success
- Reduce risk and simplify your process
- Efficiently scale to larger batches at more sites
- Accelerate time to market.
Manufacturing services
Pharmacy services
Manufacturing services
Choose Cardinal Health for our in-depth manufacturing experience in both cGMP Part 211 and 212. As the manufacturer of 11 radiopharmaceuticals, including two FDA-approved radiopharmaceuticals as a contract manufacturer and three for use in research, we can simplify the manufacturing and quality processes and help you scale strategically.
Our well-established process includes:
| Regulatory Affairs process review | We start with a detailed review of all documentation and help you develop a plan to introduce your drug efficiently and consistently. If you need help identifying trial sites, we have long-established relationships with several academic institutions that are often a good match. |
| Test runs for feasibility | Working with our quality team, we perform test runs to perfect the process and identify opportunities to improve. By taking the time to troubleshoot upfront, we can better manage risk and help ensure the overall success of your trial.
|
| Documentation transfer | Once we’ve completed test runs, we’ll do the formal documentation transfer, determine final quality elements, and train our operators to help protect your trial from variability. |
| Verification and validation | We perform a final check-in to ensure that everything is on track, with consistent doses and quality. |
| Manufacturing and continuous improvement | Next, we begin manufacturing and distributing your drug, while continually validating quality and identifying opportunities for improvement. As your needs change, we can help you adjust your distribution plan, add new geographies and scale strategically. |
Pharmacy services
We have the largest radiopharmaceutical distribution network in the U.S. and extensive experience handling and distributing complex radiopharmaceuticals.
Our well-established process includes:
| Process review | We start with a detailed review of all documentation and help you develop a plan to introduce your drug efficiently and consistently. If you need help identifying trial sites, we have long-established relationships with several academic institutions that are often a good match. |
| Setup and launch | In this stage, we align your product with our systems, train pharmacy staff on your drug and validate the first doses against the quality standards. |
| Program maintenance | After launch, we continue to closely monitor everything to ensure quality is consistent and we identify opportunities for additional changes to further optimize your processes. |
| Operational scaling and continuous improvement | To ensure long-term scalability, we make and implement a variety of recommendations in this step and continue to optimize the processes to drive efficiencies. |
Our experts navigate the complex regulatory landscape with you.
Regulatory Sciences
40
Years of global experience
800+
Clients served
150+
Regulatory scientists on staff
The Cardinal Health Regulatory Sciences team consists of industry-trained experts providing regulatory and product development consulting services required for product approval and full product lifecycle management from upfront strategy and submission to maintenance. Learn more
.
Quality & Regulatory
530
Licensed pharmacists
40
Engineers
cGMP
Part 211 and 212 experience
Through a dedicated Quality & Regulatory team, we drive the highest safety standards through a vigorous quality and regulatory philosophy to help ensure safety and efficacy of our radiopharmaceuticals. The team proactively monitors ever-changing NRC and state, FDA, DOT and environmental health regulations to help ensure compliance during development, manufacturing, preparation, dispensing and commercialization of your radiopharmaceutical.