SPRI Clinical Trials

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SPRI Clinical Trials is an international contract research organization offering comprehensive clinical research services to the biopharmaceutical industry. With strategic offices in the United States and Eastern Europe and partnerships in Western Europe, Asia and Australia, our experienced team helps clients meet the challenges of managing global clinical studies, regardless of size or complexity. [1]

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http://www.spriclinicaltrials.com/
Social Psychiatry Research Institute (SPRI)
Type Private
Founded 1972
Headquarters Pittsboro, NC
Key people NICK VATAKIS, MD, CHIEF MEDICAL OFFICER

AMY RIGNEY, M ED, PRESIDENT, CHIEF OPERATIONS OFFICER

Number of employees 51-200 employees

History

SPRI was founded in 1972, to support and conduct clinical research for antidepressant and anti-anxiety drugs. More than 40 years later, SPRI continues to use its expertise in CNS trials, as well as oncology, infectious disease and endocrinology research, to help biopharmaceutical companies design and execute global clinical trials.

FROM NEW YORK CLINICAL SITE TO INTERNATIONAL CRO SPRI has grown from a small network of clinical sites to an internationally respected contract research organization. SPRI began CRO operations in 2003 with the addition of a strategic office in Kiev, Ukraine. Today, we employ nearly 80 of the industry’s most talented clinical research professionals at our offices in the United States (New York, NY and Research Triangle Park, NC), Ukraine, Russia, Georgia and Belarus.

With headquarters in the U.S., operations in Eastern Europe and strategic partnerships in Western Europe and Australasia, SPRI Clinical Trials offers our clients several key advantages — including unique insight, local regulatory expertise and access to our established relationships with international clinical sites.

Services Offered

  • Feasibility & site selection
  • Regulatory management
  • Project management
  • Clinical site management & monitoring
  • Biostatistics and Data Management
  • Pharmacovigilance
  • Logistics management
  • Medical writing
  • Translation
  • Quality management

PHARMACOVIGILANCE

At SPRI, we have strategic tools and partners that enable us to offer complete safety monitoring and pharmacovigilance services for our clients. Whether you require a comprehensive or partial suite of services, our clinical trial safety experts are here to provide support.

SPRI Clinical Trials is happy to work with a vendor-hosted database or to provide a safety database specifically for your trial. In addition to being well-versed in medical coding, SAE reporting and creation and review of patient narratives, our team is experienced with all the major safety platforms (including ARISg, ARGUS, Clintrace and Oracle AERS), allowing us to better meet the unique needs of each client.

COMPREHENSIVE CLINICAL TRIAL SAFETY SERVICES

We’ve chosen three pharmacovigilance (PVG) providers with the capacity to offer comprehensive clinical trial safety services on a global basis. At SPRI, we know that many research sponsors choose to maintain their safety information within one database for the lifecycle of the product, allowing them to pull together their DSUR and PSUR with ease. It is with this understanding that we’ve chosen not to partner with one clinical trial safety provider but to broaden our offerings to meet the specific needs of each client.

SPRI’s clinical trial safety and pharmacovigilance services include:

  • Individual case safety report (ICSR) processing for serious adverse events (SAE)
  • 24/7 safety coverage
  • Medical monitoring
  • Aggregate reporting (safety update reports)
  • Trend analysis
  • Managing events of special interest
  • Unblinding

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Controversies

Top 5 Recent Tweets

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October 28, 2020SPRIVail.@SPRIVail was granted the #NIH Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials awa… https://t.co/mfELOAFdgW


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References

http://www.spriclinicaltrials.com/,http://www.spriclinicaltrials.com/cro-services/pharmacovigilance/
  1. http://www.spriclinicaltrials.com/

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