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Veristat Strengthens Its Long-Standing Relationship with Aegerion Pharmaceuticals

Veristat, a full service Clinical Research Organization (CRO), announced today the signing of a Preferred Provider Agreement (PPA) with Aegerion Pharmaceuticals Inc. (“Aegerion”), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases.  Veristat has assisted Aegerion with US Food and Drug Administration, EU Market Authorization Application, and Japan Food and Drug Administration submission projects over the past 5 years.

Veristat will offer Aegerion clinical trial support including statistical consulting, biostatistical analysis, clinical data management, clinical monitoring, SAS programming, clinical protocol and study report writing, project management and the preparation of regulatory submission documents.

“Veristat has been a strong and dedicated collaborative partner and an extension of our project teams,” said Pamela Foulds, MD, Vice President of Clinical Development at Aegerion Pharmaceuticals.

“Veristat is thrilled to progress to this next phase in our working relationship with Aegerion,” stated Barbara Balser, VMD, Chief Scientific Officer at Veristat. “We feel like a true partner to Aegerion and are eager to continue to deliver quality expertise and services for their marketing applications.”

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Unlock the Secrets of Effective SD File Preparation for FDA Submissions

In today's world where digital transformation is reshaping industries, even the pharmaceutical sector is not immune to...

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Regulatory Guidance Monthly Review - August 2023

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US...