SynteractHCR Enhances Adaptive Trial Capabilities
- Director of Biostatistics Dr. Greg Wei leads Adaptive Trial group -
SAN DIEGO, May 30, 2013
SAN DIEGO, May 30, 2013 /PRNewswire/ -- SynteractHCR, a leading full-service
global contract research organization (CRO), has completed validation and
training on East®, Cytel's adaptive trial software, enhancing its consulting
services on adaptive trials to its clients, especially for those smaller or
emerging companies that may not have the resources to run adaptive trial
simulations in-house. SynteractHCR now offers design, simulation and clinical
execution services for adaptive trials.
The adaptive trial group at SynteractHCR works under the direction of Dr. Greg
Wei, director of biostatistics. An expert on biostatistics for regulatory
issues, Wei has more than 20 years of pharmaceutical and statistical
experience. Wei has direct regulatory experience with the FDA and EMA, and
has presented to both agencies on special protocol assessment and adaptive
trial design, both of which are crucial areas for pharma and biotech companies
as they are pressured to increase trial efficiency and reduce study costs.
Adaptive trial designs use accumulating data to modify trials under progress
without undermining the integrity of the trials. They allow sponsors to adjust
certain parameters such as dosage, subject population, or sample size in
consideration of statistically significant safety or efficacy data. The goals
are to accelerate clinical development and improve its efficiency, better
target experimental drugs to responsive patient groups, and reduce the number
of patients exposed to inappropriate or ineffective therapies. According to
recent studies that have addressed the topic, adaptive trials save three
months in trial duration on average but may save up to a year in the trial
According to Dr. Philip Doren, vice president, Biometrics at SynteractHCR, the
inclusion of adaptive trials consulting is a critical component of the
company's approach to global clinical trials and meeting the needs of its
"Offering expanded adaptive trials capabilities is another step in providing
individualized services tailored to our clients' specific needs," says Doren.
"We continue to improve our technology capabilities as well as increase our
depth in personnel who have the expertise that clients want to improve their
trial efficiencies. Dr. Wei and his team will be able to help clients reduce
cycle times and late stage attrition rates while managing the ethical
considerations that are at the heart of everything we do."
Wei's experience with regulatory filings on several new drug applications and
regulatory agency interaction provided a strong basis for his appointment to
the position. Prior to joining SynteractHCR in autumn of 2012, Wei amassed his
pharmaceutical experience at a wide range of international companies,
including management experience as head of statistics at the China Research
and Development Center, Pfizer, Inc. and as senior principal statistician of
biostatistics at Boehringer-Ingelheim, director of biostatistics at Orexigen
Therapeutics, and director of oncology statistics at Pfizer, Inc., Wei has
been an avid user of East for sample size estimation for group sequential
design, trial monitoring, interim analysis timing and power, conditional power
calculation, and trial simulation for sample size change. He is also familiar
with theory and software for continuous reassessment methods for dose-finding
and for two-stage design for Phase II studies.
SynteractHCR has been formed from the merger of Synteract and Harrison
Clinical Research (HCR), announced earlier this year. The newly expanded
company operates from 16 locations worldwide and will provide top tier
international capabilities to support clinical trials globally, from emerging
products through post-marketing.
About SynteractHCR (www.synteracthcr.com)
SynteractHCR is a full-service contract research organization with a
successful two-decade track record supporting biotechnology, medical device
and pharmaceutical companies in all phases of clinical development. With its
"Shared Work – Shared Vision" philosophy SynteractHCR provides customized
Phase I through IV services collaboratively and cost effectively ensuring
on-time delivery of quality data so clients get to decision points faster.
Operating in 16 countries, SynteractHCR delivers trials internationally,
offering expertise across multiple therapeutic areas including notable depth
in oncology, CNS, infectious disease, endocrinology, cardiovascular, and
respiratory, among other indications.
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