05.30.08 PSC Clinical to Speak at SALSA Meeting in San Antonio, Texas

The San Antonio/Austin Life Science Association (SALSA) is an organization dedicated to promoting the life science industry in San Antonio and Austin. Monthly meetings are held to provide opportunities for life science, biotech and biomedical professionals to build relationships within the region. In attendence are local companies and individuals united in their efforts to encourage scientific growth in San Antonio and Austin.

This month's breakfst SALSA meeting speaker is Patti Rossman of PSC Clinical, who will be discussing various aspects of electronic clinical data management through her presentation, "Securing Electronic Data for Preclinical and Clinical Trials."

For more information on or to register for the May 30th breakfast meeting in San Antonio, please contact LuAnn Kirk at lkirk@incell.comor at http://www.bio-salsa.org/

04.29.08 FDA Final Ruling

On April 29, 2008, the FDA issued a final ruling to amend its regulations on the acceptance of foreign clinical studies that are not conducted under an investigational new drug application (IND) and used to support a drug or biological product's IND or application for marketing approval. Prior to the final ruling, foreign clinical studies were required to be conducted in accordance with the 1989 version (1989 Declaration) of the ethical principles of the Declaration of helsinki (Declaration) issued by the World Medical Association (WMA), which stated that studies be conducted in accordance with GCP and be reviewed and approved by an independent ethics committee (IEC). On October 27, 2008, the final ruling will become effective and update the acceptance standards, for foreign clinical studeies not conducted under an IND, to require accordance with GCP and if necessary an FDA onsite inspection to validate study data.

For more information on this ruling click the following link.
Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule

04.20.08 24th Annual SQA Meeting and Training

From April 20-25th, 2008, Pharmaceutical Services Corporation and PSC Clinical will be attending the 24th Annual Society of Quality Assurance Meeting and Training. This year the conference is held in Memphis, TN at the Memphis Convention Center. With attendees from around the nation and the world, the annual conference brings all the latest regulatory news, experts and training to one place. Pharmaceutical Services Corporation and PSC Clinical will be exhibiting on April 22-23rd from 7:30am to 4:30pm, which will be located in the SW Hall. In addition to providing more information on the services at PSC and PSC Clinical, a demo of Auditutopia™ will be available. Auditutopia™ is a web-based audit management system application, which will greatly increase the efficiency, accurateness, and organization of any audits or regulatory inspections.

The exhibit hall is adjacent to the dining room and our booth will be in the center of all the activity, so make sure to stop by during any breaks for a chance to enter your business card into the raffle.

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Pharmaceutical Services Corporation, a leader in Validation, Regulatory and Compliance Services for the Pharmaceutical, Biologics, Biotech and Medical Device Industries announces the launch of its proprietary Audit Management software, Audit Utopia™.

Audit Utopia™, designed by industry professionals, enables you to efficiently organize an audit from the US FDA, EMEA, or other regulatory agency. As all GxP-regulated quality professionals know, a regulatory agency audit is a stressful event. Audit Utopia™ manages audits by creating a real-time infrastructure to effectively organize the audit; offering your Quality Management Team the ability to monitor the progress of the audit and improve your firm's ability to respond to the
auditors' requests, ultimately freeing up resources to focus on the real work of actually addressing auditors' requirements.

Audit Utopia™ is used by the largest of the Fortune 500 medical device, pharmaceutical and biotech firms. Audit Utopia™ is offered exclusively through Pharmaceutical Services Corporation (www.biotech.com), one of the world's largest compliance consultancies and there is a configuration scheme to fit every organizations needs.

A well-managed audit impresses auditors, and impressing auditors is the key to a successful audit. Audit Utopia™ can save your firm millions of dollars by improving your performance during a regulatory agency audit. Can you afford not to have it?

For more information or to schedule a personalized demo or free trial, contact BIOTECHor call 909.784.3350 or visit www.auditutopia.comor www.biotech.com.

On March 28th, the multi-talented team from the Austin office of Pharmaceutical Services Corporation and PSC Clinical participated in BioHouston's Annual Chili Cook-off. Team PSChili spent the half-day event outside of the BioHouston offices in the Houston Medical Center eating absurd amounts of chili, partaking in limbo contests, and pretending to be chefs for the day.

 

The day started with anticipation as the team started on their journey to Houston. Upon arriving at the BioHouston offices, the team was greeted with the festive sights, sounds and smells of the 50 or so different teams setting up their booths and perfecting their chili. After struggling to put up the tents and receiving the help of many sympathetic past tent-strugglers, Team PSChili was set up and ready to share their own chili concoction. In addition to sampling chili, participants were able to meet fellow participants and get to know other life science professionals throughout the day.

At the end of the day, prizes were given out for the best chili, and although PSChili was not one of the winners, the team had enjoyed themselves immensely and was ready to start preparing for next year's event.

02.15.08 New addition to Austin's office

Carlos Estrada, a Medical Doctor graduated overseas, moved to Austin, TX from West Palm Beach, FL, where he has been working with PSC Clinical for about a year, focusing in Clinical Trial Development, and is now joining the team at the Austin office in the process of expanding the Clinical Division of Pharmaceutical Services Corporation.