This paper looks at validation of Software-as-a-Service (SaaS) solutions and provides relevant points to consider when developing a risk-based approach to validation.
How IRT vendor relationships can ensure high quality builds that meet pharma companies' needs and avoid the potential pitfalls associated with RTSM.
How to address the unique challenges of finding the right balance between drug overage and outage, ensuring every patient receives the right medication when they need it, and managing clinical trial supply.
The objective of this study was to develop and support a process for assessing the comparability of data used in global clinical trials from four individual laboratories, wholly owned by the same central laboratory entity, and that the same tests on the same samples are under statistical control and acceptable limits of variation.
Clinical oncology trials are more complex and time consuming than those in any other therapeutic area and failure rates are frustratingly high. Given the urgent need for new oncologic therapies, sponsors are eager to find more effective ways to conduct clinical research.
With the existence of new tools from cross disciplinary teams - applying innovation in study design, use of patient registries, and partnering with patient advocacy groups - the work for effective therapies continues.
An evaluation of the effect of hemolysis, icterus and lipemia on chemistry assays and further assessment of the association between the amount of interfering substances and ordinal values reported by the automated chemistry analyzer as H-, I- and L-indices.
Research in diagnosis, management, and therapy development, as well as development of standardized guidelines for upcoming studies need to be addressed in order to improve the prognosis of DFI patients.
Why condensing a study’s findings concise presentation, in an easily understood and digestible format is harder than it appears.
In order to increase the number of potentially successful clinical development projects in the microbiome space, it will be important to recognize standard drug development principles and global drug or biologic development requirements.
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