PSI INTERNATIONAL, Inc. 10306 Eaton Place, Suite 400 Fairfax, VA  22030 Tel: (703) 352-8700 Fax: (703) 352-8236

 

NEWS RELEASE

 

IMMEDIATE RELEASE:  September 26, 2005

 

Contact:         Bill York                               

                        (703) 352-9482                                                                                  

                   byork@psiint.com

SUMMARY: PSI INTERNATIONAL INC. SIGNS MULTI-YEAR MULTI-MILLION DOLLAR CONTRACT WITH FOOD AND DRUG ADMINISTRATION

FAIRFAX VA---(September 26, 2005) – PSI International, Inc. (PSI) announced that it has signed a multi-year multi-million dollar contract with the Food and Drug Administration (FDA) to support their Adverse Event Reports Processing. Per this contract, PSI will support FDA’s Post Marketing Surveillance Programs to include Adverse Event Reporting System (AERS), MedWatch Program and Drug Quality Reporting System (DQRS). As part of the contract, PSI will receive hard copy Adverse Event Reports (AERs), perform data entry, convert them to tiff images, medically code them using the Medical Dictionary for Regulatory Activities (MedDRA), perform quality assurance, and commit them to FDA’s AERS database. PSI will also be responsible for processing the AERs received electronically by FDA. The contract requires PSI to provide subject matter expertise, MedDRA-experienced personnel, supporting Information Technology infrastructure and the associated facility resources to process FDA’s mission critical AERs numbering over 400,000 per year.  

 

“This win is an evidence of PSI’s global leadership in processing AERs for federal and commercial clients.  We are grateful to FDA for their continuing trust in PSI to support their critical drug safety program,” stated Nazim Dhanani, President of PSI.

 

According to Bill York, PSI’s Director of Business Development, “We have been doing business with FDA for over 18 year. The award of the AERS contract is another vote of confidence by the agency in our unique ability to provide AERS-related support to cover a wide spectrum of  subject matter and information technology services. With our ability to provide global services, PSI is well positioned to pursue any future AERS opportunity issued by a regulatory, scientific or commercial entity, anywhere in the world.”  

 

 

PSI International, Inc. Background Information

PSI INTERNATIONAL, Inc. is a Fairfax, Virginia-based company that has provided innovative information technology, health science, and social services solutions for over 23 years to government and private sectors. The Company specializes in integrating information technology services with subject matter expertise in health and human sciences. The Company serves federal, state and commercial clients on a global basis. More information on the company can be obtained at www.psiint.com or www.meddrahelp.com.