|
|
Awards and Recognition
Quintiles Asia Pacific Receives Frost & Sullivan Awards
Quintiles’ East Asia subsidiary was recently named the Asia Pacific region’s Multinational Clinical Trials Service Provider of the Year and Multinational CRO of the Year by the consulting firm Frost & Sullivan. Frost & Sullivan presents the awards to companies that demonstrate “best practices in their industry, commending the diligence, commitment and innovative business strategies required to advance in the global marketplace.” Anand Tharmaratnam, M.D., CEO of Quintiles East Asia and Head of Asia Pacific Clinical Development said, “These awards confirm our market-leading position as the fastest growing and most experienced CRO in Asia, with the largest geographic footprint.” Tharmaratnam also feels that the awards reflect on the dedication, expertise and loyalty of the team in the Asia Pacific region. Last year, Quintiles started 76 new clinical trials in the Asia Pacific region and has a total of more than 200 ongoing studies there. The company also opened new offices in Vietnam and Indonesia, in addition to existing offices in Australia, New Zealand, China, Korea, Malaysia, Philippines, Singapore, Taiwan and Thailand.
FDA Recognizes Quintiles’ Gary Walker
In recognition for his work in creating standards for electronic data submission, Quintiles’ Gary Walker, Associate Regulatory Director in Global Data Management, received the Leveraging/Collaboration Award from the FDA’s Office of the Commissioner. As a member of the Submission Data Standards Team for CDISC -- the Clinical Data Interchange Standards Consortium, Gary was recognized for creating a standard Study Data Tabulation Model and an implementation guide. Standardized electronic data submissions can reduce the time needed for regulatory review, thus getting new medicines to patients faster.
Quintiles’ Expertise in Adaptive Trial Design
As part of its Critical Path Initiative, the FDA has endorsed the concept of “adaptive design,” where pre-specified changes can be made to the course of a clinical trial as data are collected in the trial. Such designs can in many cases improve the drug development process by reducing time while maintaining the integrity of the trial.
Quintiles has developed or implemented a number of adaptive designs for sponsors. These adaptive designs have incorporated one or more of:
• Stopping for futility, when there is little chance that a statistically significant result can be obtained
• Stopping for early demonstration of efficacy, which can save both time and cost
• Sample size reassessment, e.g., to compensate for variability larger than anticipated and thus avoid reducing the chances of a successful trial
• Combination of Phase IIB dose selection stage with Phase III confirmatory stage to produce a "Seamless Phase IIB-III trial" - which can save a substantial amount of time.
|