Spaulding Clinical and FDA Study Contributing to Efforts to Address Opioid Crisis
WEST BEND, Wis.--(BUSINESS WIRE)--Spaulding Clinical, a full-service Phase I clinical service provider, today announced expanded services for clinical trial Phases I through III, including biometrics, data management, and medical writing. While approaching their 15th anniversary and coinciding with the company’s concurrent rebranding and new website, Spaulding’s deep experience and expertise in these areas can now be utilized in other phases of the clinical trial journey.
West Bend, Wis., Feb. 27, 2020 (Business Wire) – Spaulding Clinical Research today announced that it has been awarded a five-year contract with the U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science to conduct multiple clinical trials in various therapeutic areas of interest. They have kicked off this agreement with $5 million of clinical trial work to be run in 2020. Spaulding Clinical is responsible for conducting the trials and providing the necessary support services including clinical trial recruitment, conduct, and laboratory assessments.
Today, Spaulding Clinical Research, LLC, a global clinical pharmacology, cardiac safetynand biometrics solutions provider, announces the opening of their European Office in Leiden, ThenNetherlands. This new European office will be led by John Blank as Managing Director, EuropeannOperations. Mr. Blank has 20+ years of experience in the contract research & development industry onnboth sides of the Atlantic, managing and growing global teams.
Evoke Pharma (NASDAQ:EVOK) announced an agreement with Spaulding Clinical Research for a trial of the company’s lead product Gimoti comparative exposure pharmacokinetic trial.nnAs quoted in the press release:nnThe pivotal PK trial conducted in healthy volunteers is designed to establish bioequivalence with the listed drug, Reglan® Tablets, and may serve as a basis for the 505(b)(2) new drug application (NDA) planned for submission to the Food and Drug Administration (FDA).nnThis PK trial follows recent communications with FDA regarding the final clinical development steps for the NDA submission. The Company held a face-to-face pre-NDA meeting with FDA in December 2016 to propose and discuss this PK trial and recently confirmed the final protocol design during a Type A Meeting with FDA last month. The Company engaged Spaulding to execute this trial and is now in the latter planning stages to initiate the trial.
Spaulding Clinical Research, LLC, a global clinical pharmacology, cardiac safety and biometrics solutions provider, today announced that the Spaulding Electrocardiograph 2100iQ™ is to be exhibited at the Drug Information Association’s (DIA) 2016 conference.
Spaulding Clinical Research to Showcase Customers Fully Automated Phase I Clinical Data Integration with Medidata Rave at DIA