Your trial. Your patients. Your success. Our commitment.

Behind every trial you run is a patient waiting for a better option. We’re here to help you get them there – rigorously, efficiently, and with care. 

Whether you are planning your first-in-human study, building a pivotal evidence package, or generating real-world data post-approval, our clinical teams in Italy and Spain work alongside you at every stage. We combine global with deep local expertise – from EMA and FDA requirements to ethics committee processes and site networks – combined with the strategic reach of PLG’s integrated regulatory, pharmacometrics, and market access capabilities. 

From first-in-human studies through pivotal trials to post-approval and observational research – if your program needs clinical expertise, in Europe, and particularly in Italy and Spain, we can support you across the full development lifecycle. Whether you need a comprehensive clinical strategy or targeted expert support to strengthen an existing program, we adapt to your needs and your timeline. 

 

If you are a manufacturer of medical devices, we can support you both in evidence generation to enhance your business or to develop the requested clinical trials to support the notified body certification, developing an end-to-end project.   

What we deliver

Strategy & design 

  • Clinical development strategy from Phase 1 through Phase 4, including post-approval and observational research 
  • Protocol design and endpoint selection aligned to EMA and FDA requirements 
  • Endpoint strategies informed by market access and reimbursement considerations – so your evidence package supports both approval and commercial success 
  • Adaptive and simulation-informed trial designs, leveraging PLG’s pharmacometrics capabilities 
  • Identification of the comparator

 

Operations & execution 

  • Site identification and investigator selection across established networks in Italy and Spain 
  • Clinical trial management: monitoring, data management, and vendor oversight 
  • Ethics committee submissions and national authority interactions 
  • Regulatory support for protocol amendments, scientific advice procedures, and agency queries 

  

Evidence & documentation 

  • Clinical study reports and integrated summaries of efficacy and safety (ISE/ISS) 
  • Real-world evidence (RWE) study design and execution 
  • End-to-end coordination with PLG’s regulatory affairs, pharmacometrics, and market access teams 
  • article publication to generate scientific evidence  

Where we outperform

  • Deep local expertise in Italian and Spanish regulatory environments, ethics committee processes, and investigator networks – built over years, not assembled for a pitch 
  • Fully integrated with PLG’s global capabilities – your European trial connects seamlessly to your global regulatory strategy, CMC program, and pharmacometric modeling 
  • From first-in-human to post-approval observational studies – one clinical partner across the full development lifecycle 
  • Market access lens built into trial design from the start – endpoint strategies that support reimbursement, not just approval 
  • Adaptive and simulation-informed designs leveraging PLG pharmacometrics — reducing trial risk before the first patient is enrolled 

PLG Difference

Whether you are exploring your clinical strategy, need operational support in Italy or Spain, or want a partner who connects clinical development with regulatory and market access – our European CRO team is ready.

We welcome the conversation.