News
OCTOBER, 2009:
ClinOps, LLC Enhances Senior Management Team with Addition of Connie Andrews as Senior Vice President of Clinical Operations.
SAN FRANCISCO, CALIFORNIA (October 26, 2009) – ClinOps, LLC, a customer service focused clinical research organization, announced today that Connie Andrews has joined the company as Senior Vice President of Clinical Operations. Connie brings with her more than 28 years of clinical research experience in multiple therapeutic areas including infectious disease, gastrointestinal diseases, cardiovascular, central nervous system, oncology, etc.
In her new role, Connie will be responsible for project management, clinical monitoring, training and development, client relations and growth initiatives and will also work to further the expansion of ClinOps’ clinical operations.
Prior to joining ClinOps, LLC Connie held positions across large and mid-sized Pharmaceutical, Biotechnology and Clinical Research Organizations. She has led many global initiatives and process improvement committees to implement operating efficiencies and strategic global programs resulting in increased effectiveness and winning study designs.
“The combination of Connie Andrews’ expertise and experience make her an ideal addition to the ClinOps senior management team,” stated Denis Lin, CEO and President. “She brings not only superb understanding of contract research, but also an excellent perspective from the sponsor’s side of the business. Connie will be able to provide excellent insights as ClinOps strives to achieve highly efficient trial outcomes, optimizing and accelerating the drug development process of our customers.”
Connie holds a Master’s degree in Psychology and has been an active member of several industry organizations including:
- Board of Directors, Healthcare Businesswomen’s Association. 2004-2005
- Advisory Board Member, Partnerships with CROs Annual Meeting. 2004-2006
- Advisory Board Member, Pharmaceutical Training Institute (PTI). 2004 – 2006
- Scientific Advisory Board Member, IBC USA Conferences (Pharmaceutical Development Series)
Connie has been recognized with the following prestigious distinctions:
- 2,000 Notable American Women
- Who’s Who of American Women
- Who’s Who in Medicine and Healthcare
- Who’s Who in the World
- Who’s Who in America
- Who’s Who Among Executives and Professionals
- Who’s Who Registry Among Executive and Professional Women
MAY, 2009:
ClinOps, LLC Introduced as Newly Named Best in Class Contract Research Organization.
Bound Brook, NJ and San Francisco, CA – May 12, 2009 – Pacific Data Designs, LLC (“PDD”) and ClinPro, Inc who joined forces in November 2008, have fully merged and are now ClinOps, LLC. Spun from two best- in-class companies among contract research organizations (“CRO”), Both PDD and ClinPro have established reputations for excellence and share a strong commitment to exceptional client service.
ClinOps, LLC will continue to expand its long standing expertise in Clinical Data Management and Statistical/SAS Programming services and in specialized clinical operations with a focus on Investigator sponsored trials for the Biotechnology, Pharmaceutical and Medical Device industries with expanded reach and capabilities. ClinOps will excel in assisting clients to advance and accelerate their therapeutic clinical drug development initiatives.
“Clinops is a highly-recognized and universally accepted term in our industry. We are fortunate to have ClinOps, LLC as our name. We are not your traditional full-service CRO. Our best-in-class business model is designed to offer expert services focused in the areas of Data Management, Statistics and Investigator-initiated studies” said Dr. Denis Lin, President & CEO of ClinOps, LLC.
Dr. Lin joined ClinOps, LLC in November 2008. Prior to joining ClinOps, he was President and CEO of Tandem Labs/NWT Inc. He built Tandem Labs from its inception to being the market leader in the CRO bioanalysis niche. He intends to lead ClinOps, LLC in its goal to become the market leader in its niche.
NOVEMBER, 2008:
EXCITING NEWS!
ClinPro and PDD are merging to form a national entity with locations on the east and west coasts. The combined companies come armed with a combined 39 years of experience in clinical research. The name of the newly formed entity is presently being selected by the employees of PDD and ClinPro. More details related to the transaction are available in the press release.
SEPTEMBER, 2008:
PACIFIC DATA DESIGNS AT 2008 ANNUAL CONFERENCE FOR THE SOCIETY FOR CLINICAL DATA MANAGEMENT IN DALLAS, TEXAS
The 2008 Annual Conference for the Society for clinical Data Management (SCDM) will be held in Dallas, Texas from Sunday, September 21 through Wednesday, September 24 at the Hyatt Regency Dallas. SCDM is a non-profit professional society founded in 1994 to advance the discipline of clinical data management. Members are from pharmaceutical companies, biotechnology firms, Clinical Research Organizations, software and hardware vendors, academia, consulting firms and more.
MAY, 2008:
PACIFIC DATA DESIGNS AT 44TH ANNUAL DIA MEETING IN BOSTON JUNE 22-25
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!
APRIL, 2008:
Pacific Data Designs’ Services Contribute To Health Canada’s Approval
FzioMed, Inc. announced in February 2008 that Health Canada has approved the company's Oxiplex(R) gel for use in lumbar spine surgery. Health Canada's approval of Oxiplex for spine surgery was based on final data from a U.S. multi-center, randomized, blinded, controlled study involving 352 patients that Pacific Data Designs provided Data Management and Statistical Analysis/Programming support on. The company has filed a Pre-Market Approval Application with the FDA seeking approval to market Oxiplex in the U.S.
MARCH, 2008:
Pacific Data Designs At AACR April 12-16
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.
FEBRUARY, 2008:
Nothing But Positive Feedback For pddEtrials EDC System
In an effort to ease the progression from paper-based trials to EDC, Pacific Data Designs continues support by providing a seamless transition through pddEtrials. Originally built in 2001 as an EDC-ready data management system, pddEtrials has been getting positive feedback from both sponsors and sites. Pacific Data Designs remains ahead of the learning curve for EDC, bypassing many of the obstacles and challenges that vendors are facing in becoming efficient and knowledgeable in EDC.
JANUARY, 2008:
Pacific Data Designs At 12th Annual Drug Delivery Partnerships In San Diego Jan 21-23
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:
SUPPORT FOR 9-STUDY NDA RESULTS IN PRODUCT APPROVAL
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:
PACIFIC DATA DESIGNS’ SAS PROGRAMMERS RECEIVE AWARDS
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 AT 43RD ANNUAL DIA MEETING IN ATLANTA JUNE 17-20
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:
EDC DATA AVAILABLE FOR CLIENTS WITHIN HOURS OF PATIENT VISITS
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 CONTINUES TO MEET AND BEAT TIMELINES
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:
FAST-GROWING PACIFIC DATA DESIGNS KNOCKS DOWN WALL TO MAKE SPACE
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:
2000 PATIENT REGISTRY TRIAL COMPLETED
Pacific Data Designs completes the management of a 2,000 patient registry trial for a medical device client.
SEPTEMBER, 2005:
DATA MANAGEMENT AND STATISTICAL SUPPORT FOR 305 PATIENT TRIAL ENDS IN FDA APPROVAL AND 510(K) CLEARANCE
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 SUPPORT FOR PHASE III MULTI-NATIONAL STUDY
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 MOVES OFFICE TO HEART OF SAN FRANCISCO’S FINANCIAL DISTRICT
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 MOVES HIGHER IN INC’S TOP 500 FASTEST GROWING COMPANIES
Pacific Data Designs ranked 329 on INC Magazine's Top 500 Fastest Growing Private Companies in the United States.
SEPTEMBER, 2004:
SUPPORT FOR A 527 PATIENT PHASE III TRIAL ENDS IN FDA APPROVAL
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 IN INC’S TOP 500 FASTEST GROWING COMPANIES
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 IN SAN FRANCISCO BUSINESS TIMES TOP 100
Pacific Data Designs ranked 41 on San Francisco Business Times '100 Fastest Growing Private Bay Area Companies'.
SEPTEMBER, 2003:
PACIFIC DATA DESIGNS LAUNCHES SAE MANAGEMENT ON PDDETRIALS
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 IN INC’S TOP 500 FASTEST GROWING COMPANIES
Pacific Data Designs ranked 160 out of 500 on INC Magazine's Top 500 Fastest Growing Private Companies in the United States.
