News
MAY, 2008:
Pacific Data Designs will be exhibiting at DIA’s 44th Annual Meeting on June 22-25 2008 in Boston, MA at the Boston Convention & Exhibition Center. Please visit us at Booth #1754!
MARCH, 2008:
Pacific Data Designs will be attending the American Association for Cancer Research (AACR) Annual Meeting April 12-16, 2008 at the San Diego Convention Center in San Diego, CA. For more information, see www.aacr.org. Pacific Data Designs will also be attending the 17th Annual Partnerships with CROs April 14-16, 2008 at the Mandalay Bay Convention Center in Las Vegas, NV. For more information, see www.iirusa.com.
JANUARY, 2008:
Pacific Data Designs will be attending the 12th Annual Drug Delivery Partnerships January 21-23, 2008 at the Manchester Grand Hyatt Hotel in San Diego, CA. For more information, see http://www.iirusa.com/ddp/event-home.xml.
OCTOBER, 2007:
Pacific Data Designs continues to support its clients by providing Data Management, SAS Programming, and Statistical services on an upcoming 9 study NDA involving approximately 1,000 subjects and 66,000 case report forms. Pacific Data Designs performed an integrated Summary of Safety (ISS) incorporating seven of these study data sets. Six of the operational databases were converted to CDISC SDTM Version 3.1.1 Domains for FDA submission. Additionally, the analysis databases and ADaM-compliant metadata were provided for the ISS to generate final define.pdf for FDA submission.
Update: BioMarin announced in December 2007 that the FDA granted marketing approval for KuvanTM (sapropterin dihydrochloride), the first specific drug therapy approved for the treatment of phenylketonuria (PKU).
OCTOBER, 2007:
At the recent Western Users of SAS Software (WUSS) conference in San Francisco, PDD programmers Chunmei Yang and Jeanina Worden were awarded the Best Contributed Paper Presentation Award with their paper "One Datum to Remember: RETAIN Statement."
JUNE, 2007:
Pacific Data Designs will be exhibiting at the 43rd annual DIA meeting in Atlanta, GA. June 17-20. Please visit us at booth 1947!
MAY, 2007:
Pacific Data Designs provides EDC services via pddEtrials for a global Registry study. Clients logon to pddEtrials.com to review their EDC data within hours of a patient visit as the Site Coordinators have entered the data at their site. This special study also has paper CRFs at a few of the sites making the data management process more challenging.
MARCH, 2007:
Pacific Data Designs completes the Data Management, SAS Programming and Statistical services on 6 global studies spanning 3+ years with the processing of over 47,000 CRFs for an upcoming fast-track, orphan drug NDA filing. Each and every timeline defined by the Client was met or exceeded. Pacific Data Designs also managed the ISS and ISE database programming.
OCTOBER, 2006:
Pacific Data Designs continues to expand its capacity by acquiring the remaining space on the 8th floor of its downtown San Francisco office.
AUGUST, 2006:
Pacific Data Designs completes the management of a 2,000 patient registry trial for a medical device client.
SEPTEMBER, 2005:
FDA approval and 510(k) clearance was granted to a Medical Device Client of Pacific Data Designs to treat patients at risk of stroke. Pacific Data Designs provided Clinical Data Management and Statistical services for this trial involving 305 patients from 30 sites treated in the United States and Australia.
JUNE 1, 2005:
Pacific Data Designs continues its comprehensive data management and statistical services on BioMarin's multi-national phase III trial of Naglazyme TM (galsulfase), the first U.S. FDA-approved therapy for mucopolysaccharidosis VI (MPS VI). BioMarin announced that it had received marketing approval for this critical new treatment on June 1, 2005. 26,000+ CRFs have been processed to date. BioMarin was able to utilize pddEtrials, our on-line data management system, to remotely access their clinical data throughout the trial. Approval for Naglazyme TM in the European Union could come as early as the beginning of 2006.
JANUARY, 2005:
Pacific Data Designs expands its capacity by moving into 10,000 square feet of office space in downtown San Francisco.
OCTOBER, 2004:
Pacific Data Designs ranked 329 on INC Magazine's Top 500 Fastest Growing Private Companies in the United States.
SEPTEMBER, 2004:
Pacific Data Designs completes the management of a 527-patient, phase III pivotal trial over a quick 9 month period. 45,000+ CRFs were processed over the life of the trial. We provided full Data Management and Statistical services on this trial including study design, sample size calculations, remote data access via pddEtrials.com, scanning of CRFs and queries following ICH guidelines, and the submission of the final datasets to the FDA following CDISC guidelines, version 3.0. Our Client received FDA approval for this product on March 28, 2005.
OCTOBER, 2003:
Pacific Data Designs ranked 450 on INC Magazine's Top 500 Fastest Growing Private Companies in the United States.
OCTOBER, 2003:
Pacific Data Designs ranked 41 on San Francisco Business Times '100 Fastest Growing Private Bay Area Companies'.
SEPTEMBER, 2003:
Pacific Data Designs has launched the newest feature of pddEtrials.com, Serious Adverse Event (SAE) management. Our SAE database handles the processing and reporting of an SAE on the MedWatch 3500A form and/or the CIOMS form. This feature allows easy export to these documents which are submitted to the regulatory agencies by a Client representative. Access to this data is gained by logging onto our pddEtrials.com website using a secure UserID and password provided by your Project Manager.
OCTOBER, 2002:
Pacific Data Designs ranked 160 out of 500 on INC Magazine's Top 500 Fastest Growing Private Companies in the United States.
