Indian CRO_Semler, Fiddle with trial data: US FDA

On April 20, 2016, the United States Food and Drug Administration’s (FDA or Agency) Notification (FDA Notification) to Pharmaceutical Companies that used Indian contract research organization (CRO) Semler Research Private Limited (Semler or Company) for conducting clinical and bioanalytical studies revealed that the studies are unacceptable due to data integrity concerns.

The FDA Notification also revealed that the Company’s bioanalytical facility was the subject of an inspection by the FDA during September 29, 2015 and October 9, 2015 that resulted in an Untitled Letter on April 19, 2016. The primary focus of the Form 483 and Untitled Letter are data integrity and controls over computer systems and records. These concerns were not limited to the FDA as the April 12, 2016 Notice of Concern (NoC) issued by the World Health Organization’s (WHO) Prequalification Team (PQT) reveals similar good clinical practices (GCP) and good laboratory practices (GLP) deficiencies.

In comparison to the FDA’s Form 483 and Untitled Letter, the WHO’s NoC identifies the products approved and pending approval under the Prequalification program that are implicated by the data integrity issues as well as alleges Semler engaged in organizational fraud at various levels of the organization

Check out these FDA notification to Pharma companies here. Also check out the FDA’s letter to Semler here. Read about the full story here.

 

Drugs<>Therapeutics<>Big Pharma
impas Natesh Prabhu Administrator & Chief Editor | Clinical Pharmacologist | Diabetic-Sexual Medicine-Regenerative Therapy Consultant | President, Indian Medical Pharmacologists Association
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