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European Pharmaceutical Contractor
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| Sunil Gupta and Mandyam Srirama at Quintiles offer guidance on making the most of training for statistical programmers
For the past few years, pharmaceutical and biotech industries have enjoyed healthy growth that has created a unique opportunity for SAS programmers. Not only did the industry demand an increase in numbers of these skilled personnel, there were also new requirements for more advanced statistical programming skills for tasks such as the identification of difficult study-related data issues, and the programming and validation of more complex tables, lists and graphs. With a severe shortage of SAS programmers with clinical knowledge, experience and an abundance of skilled SAS programmers from other fields, pharmaceutical companies and CROs needed to re-evaluate their staff orientation and training programmes to better meet the needs of the new environment. |
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Sunil K Gupta is the Associate Director of Statistical Programming at Quintiles in Thousand Oaks, CA. He has been using SAS® software for over 14 years and is a SAS Base Certified Professional. He was the programme chair for the Western Users of SAS Software conference in 1998 and a speaker at numerous SAS User Group International and regional conferences as well as corporations. Sunil has over 50 publications to his name, and, in addition, he teaches the SAS course Best Practices in SAS Statistical Programming for Regulatory Submission.
MK Srirama, Senior Director, Biostatistics at Quintiles in Thousand Oaks, has over 25 years of experience in the pharmaceutical and CRO industry. Prior to joining Quintiles in 2004, Srirama had an extensive career with Warmer-Lambert/Parke-Davis, where he held several positions of increasing responsibility in their Biometrics Division, ultimately serving as Director of Biostatistics. In addition, he also previously worked for over six years for a leading CRO in establishing and growing its Biostatistics Department. Dr Srirama has a PhD in Biostatistics from the University of California, US. |
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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