Wayne, PA - 31 MAY 2017 Prosoft Clinical (“Prosoft”), a full-service clinical research organization with over 20 years’ experience in the design, conduct, and analysis of clinical studies, is pleased to announce that the US Food and Drug Administration (FDA) has just completed a clinical study audit at the Wayne, PA facility. No critical findings were noted and no Form 483 was issued. This 3-day audit was conducted from May 23 - 25 in support of the recent submission of an NDA with two multicenter pivotal clinical studies. Prosoft Clinical managed the two pivotal as well as other studies in this program, and was responsible for the medical writing of the protocols and final study reports, the design of eCRFs and electronic collection of data, monitoring of clinical sites, and statistical analysis of the data.
During the course of the audit, numerous requests were made for detailed documentation including the monitoring and auditing processes provided by Prosoft, the internal SOPs, employee training and qualification, as well as documentation collected and maintained from the monitoring visits at clinical investigator sites.
The FDA audit also included an inspection of Prosoft’s proprietary Electronic Data Capture (“EDC”) system, designed and validated by Prosoft Clinical to meet the unique data collection requirements of each protocol.
The audit findings confirmed Prosoft’s compliance with FDA’s Good Clinical Practice (“GCP”) regulations, including 21 CFR part 11, and confirmed Prosoft’s quality monitoring and medical writing practices, as well as their internal SOPs.
“This audit outcome is another testimonial to Prosoft’s strong commitment to quality clinical research, with the highest level of compliance to regulatory requirements and GCP.” said Dror Rom, PhD, President and Chairman of Prosoft Clinical, “It was 4 years of dedicated efforts by many individuals on the Prosoft Team that led to this successful outcome, which is not only important for Prosoft, but also for our client’s NDA review process”
About Prosoft Clinical Prosoft Clinical is a contract research organization focused on pharmaceutical product design and development. Since 1995, Prosoft has been providing services to the pharmaceutical, biotech, and medical device industries in areas including dermatology, cardiovascular, respiratory, allergy, immunology, CNS and oncology. Our team has a longstanding track record of excellence in bringing products to market.
For more information on the capabilities of Prosoft Clinical, please visit our web site at ProsoftClinical.com or contact us.