Radiopharmaceutical CRO Services from Top CRO
Work with the leading radiopharmaceutical CRO
Radiopharmaceutical studies are still evolving and still ultra-complex, and even small pitfalls can mean huge delays and budget overruns for your study. This demanding field calls for an expert — someone who’s pioneered it and delivered similar studies time and again.
#1
in-industry theragnostic approval
40%
pivotal RLT studies
1,000+
qualified RLT sites
Nuclear Medicine CRO Trial Solutions
Radiopharmaceuticals have opened exciting new avenues in the field of precision medicine. The latest research is turning toward diagnostic and therapeutic applications beyond oncology, including neurological disorders, infectious diseases, bone metastases, and more. The art of running radiopharmaceutical studies lies in “informed foresight” — not only the expertise to pivot when challenges arise, but to account for the unique challenges of this drug class from day one.
Choosing the wrong partner for a radiopharmaceutical study carries significant risks: activated sites that don’t have licenses, mismatched PI specialties, an imaging vendor lacking dosimetry expertise, or undertrained CRAs. By selecting PSI, you’ll be working with the CRO that delivered the first-ever targeted radioligand therapy to market, continually pioneering clinical research in the rapidly expanding radiopharmaceutical sector.
PSI Radiopharmaceutical Highlights – Pioneering the Space
Being at the forefront of radiopharmaceutical research means:
- Continually expanding a network of sites with specialized radiopharmaceutical workforce
- Helping create new-to-RLT-research sites to address the demand and the limited infrastructure challenges
- Creating new, unique roles and programs to support the busy or RLT-naïve site teams
- Working with regulators in countries unfamiliar with radiopharmaceuticals to expedite review and approvals
- Collaborating with global manufacturing and supply chain partners — including academic and industry leaders like the University of Missouri and Xcancer — to help secure and scale isotope availability for next-generation therapies.
Enroll your registrational radiopharmaceutical trial on time with PSI
PSI Radiopharmaceutical Therapeutic Expertise
Your clinical trial deserves a specialized team. Here’s how PSI supports your trial:
- Radiopharmaceutical strategy team dedicated to developing tailored recruitment plans and training curriculum, organizing communication and logistics across multidisciplinary site teams, and supporting the project teams
- Radiopharmaceutical division that houses experts in the fields of nuclear medicine, imaging, dosimetry and physics, and nuclear pharmacy
- Over 20 board-certified in-house oncologists with radiopharm clinical experience in clinical trials
- Over 40 oncologists on PSI’s Scientific Advisory Board, including radiologists and a neuroradiologist
- Over 1,000 vetted radiopharm sites with clinical trial experience
Isotopes
- 177Lu
- 68Ga
- 225Ac
- 212Pb
- 64Cu
- 89Zr
- 18F
- Tc-99m
- 153Sm
Targets
- PSMA
- SSTRs
- FRs
- GRPR
- Integrin αvβ6
- SCFAs
- GPC3
- FAP
RLT Clinical Trial Geography
- North America
- South America
- Europe, Western/Central/ Eastern
- Asia Pacific
Indications
- Prostate cancer
- GEP-NETs
- NSCLC
- Osteoblastic metastatic bone cancer
- Hepatocellular carcinoma
- Pancreatic ductal adenocarcinoma
- Breast cancer
- Parkinsonian syndrome
- Pain
Specialized RLT Trial Support Services
Radiopharm Site Development Program
When qualifying sites for your radiopharm study, you need to go beyond the basics. Some key questions include:
- Does the center have enough nuclear pharmacists on site?
- Does the nuclear medicine department have clinical research experience? If not, who will provide the training or on-site support?
- Does the site have active radioactive materials licenses?
- Which isotopes are listed? Amounts permitted?
- What’s the site’s approval process?
- Does the site have the appropriate equipment and capabilities to match your study?
Our dedicated site development program equips motivated research centers with the training, infrastructure, and regulatory support needed to participate in radiopharmaceutical trials. This dual focus expands global site capacity and stabilizes delivery logistics — giving you a reliable, scalable framework for successful trial execution.
In-House Imaging and Dosimetry Expertise
Imaging and dosimetry are two of the most daunting parts of planning radiopharmaceutical development. Sites often need additional education and support for this complicated process, and many CROs don’t have the answers. As a result, issues with qualification are one of the most common reasons for delays in radiopharm study start-up.
With PSI, your trial’s sites will have access to our licensed imaging and dosimetry specialists throughout the study, starting with review of the protocol and dosimetry plan alongside the vendor to identify any red flags. These specialists work directly with sites to walk them through the qualification process, including the use of SPECT/CT and planar scanners (as well as PET/CT for diagnostics), gamma and well counters, and dose calibrators for dose calculation.
One Seamless Team Dedicated to On-Time Delivery of Pivotal Studies
With larger providers that offer little communication between departments, it’s easy to feel like you’re on your own amid these complex studies. Expertise may also be limited to specific indications or therapeutic areas. As radiopharmaceutical development becomes more varied, these blind spots can balloon into costly delays.
Enjoy the peace of mind of a multidisciplinary radiopharmaceutical team that is solely dedicated to navigating the complexities of these studies. This integration eliminates silos, ensuring your entire project team is aligned and can work effectively throughout the trial process. It also means your team is better positioned to proactively identify and mitigate potential issues early so your study stays on track.
I would personally like to acknowledge and thank the entire PSI team and leadership for the dedication, perseverance and determined support that supported the early completion of the (...) study. Your team have showcased all the capabilities and attributes of a best in class CRO for project delivery. Your efforts will greatly support changing the treatment options for Prostate Cancer patients.
Talk with PSI’s radiopharmaceutical team
With PSI, you’re never alone with these challenging trials. Get in touch with our team of experts today.
Trusted to Deliver
When you partner with PSI, you work with a team recognized by independent industry organizations and sponsor surveys for what matters most in clinical research: expertise, consistent operational excellence, and reliable delivery.
