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European Pharmaceutical Contractor
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| Kristof Schellis and Joris De Bondt of SGS Life Science Services consider the highs and lows of putting CDISC SDTM and ADaM datasets into practice
CDISC has offered the medical research industry a standard by which data collection can be measured, which has already led to an enormous improvement for the business world. The FDA is recognising these standards and is encouraging submissions that include SDTM datasets, ADaM analysis datasets and metadata provided in define.xml files. On the other hand, getting a database to the point of full compliance and associated metadata ready for submission to the FDA is a labour-intensive job that requires a clearly thought-out management plan.
USING CDISC STANDARDS FOR A SUBMISSION
The starting point for each submission is to decide which version of the CDISC model will be used for preparation of the data. Ideally, all data will be found in one and the same model in order to avoid confusing the reviewers at the registration authorities. After the choice has been made, it is possible that new models can appear before your submission has occurred. Experience has shown that this is not really an issue, as it is practically impossible to comply with all the latest guidelines. One option is to compose a guideline for your specific situation, where the applicable domains for the planned submission are specified in detail. Such a guideline might be the sponsor’s completion of the CDISC SDTM 3.1.1 model and will contain, for example, the definition for the ‘subject reference end date/time’. One sponsor might have a preference for one definition: ‘The value of RFENDTC equals to the date of last contact’; another sponsor can opt for a definition that fits more closely to the design: ‘The value of RFENDTC equals the date/time of last medication intake’. The many permutations of CDISC creates the opportunity to invent your own interpretation, such as the identification of observations to be flagged as a baseline value. The starting point for each submission is to decide which version of the CDISC model will be used for preparation of the data. Ideally, all data will be found in one and the same model in order to avoid confusing the reviewers at the registration authorities. After the choice has been made, it is possible that new models can appear before your submission has occurred. Experience has shown that this is not really an issue, as it is practically impossible to comply with all the latest guidelines. One option is to compose a guideline for your specific situation, where the applicable domains for the planned submission are specified in detail. Such a guideline might be the sponsor’s completion of the CDISC SDTM 3.1.1 model and will contain, for example, the definition for the ‘subject reference end date/time’. One sponsor might have a preference for one definition: ‘The value of RFENDTC equals to the date of last contact’; another sponsor can opt for a definition that fits more closely to the design: ‘The value of RFENDTC equals the date/time of last medication intake’. The many permutations of CDISC creates the opportunity to invent your own interpretation, such as the identification of observations to be flagged as a baseline value. |
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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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