Regulatory Management

Local expertise is the key to ensuring a seamless regulatory submission process for your clinical trial. Leveraging our local expertise, SPRI’s regulatory team can proactively guide you through potential challenges. Our clinical trial compliance experts will closely monitor the risks associated with each submission in order to optimize your research timelines and ensure the success of your study.

Once the clinical trial has begun, you can rely on this same team of professionals to take care of all ongoing interactions with the regulatory agency. Count on SPRI to handle all details of the clinical research compliance process, including:

  • Amendments
  • Serious Adverse Event (SAE) reporting
  • SUSARs
  • Annual reports
  • Study close-out reports

SPRI: The Regulatory Submission Experts

There is a reason that SPRI Clinical Trials is often contracted by larger CROs to handle their regulatory submissions. Our team of compliance experts understands local regulations and stays up-to-date on legal changes that have the potential to affect the management of your study. SPRI’s knowledge and established relationships allow us to effectively navigate the unique challenges of international clinical trial regulations.

At SPRI, we’ve evaluated our regulatory management processes to ensure that we can generally beat the approval times of other contract research organizations, providing a faster initial submission and review process for our clients. Contact SPRI Clinical Trials today to learn about our regulatory submission and management services. With strategic offices in the United States (New York and North Carolina), Ukraine, Russia, Georgia and Belarus and strategic partnerships in Western Europe and Australasia, we have the local expertise necessary to manage your regulatory process effectively and efficiently.