White Papers

  1. Risk-Based Validation Of SaaS Solutions: Points To Consider

    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.

  2. Top Five Reasons You Need IRT Expertise (Not Just Software)

    How IRT vendor relationships can ensure high quality builds that meet pharma companies' needs and avoid the potential pitfalls associated with RTSM.

  3. 3 Challenges Clinical Trial Managers Face

    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.

  4. Central Laboratory Interlaboratory Comparison Program To Assess The Comparability Of Data Of Tests From Four Regional Laboratories Involved In Global Clinical Trials

    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.

  5. The Promise And Challenge Of Adaptive Design In Oncology Trials

    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.

  6. In Their Lifetime: Outlook For Rare Disease And Orphan Drug 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.

  7. Effect Of Hemolysis, Icterus And Lipemia On Chemistry Tests And Association Between The Amount Of Interfering Substances And LIH Indices

    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.

  8. Diabetic Foot Infections: Opportunities And Challenges In Clinical Research

    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.

  9. Plain Truth About Outsourcing Plain-Language Summaries

    Why condensing a study’s findings concise presentation, in an easily understood and digestible format is harder than it appears.

  10. The Microbiome In Clinical Trials: Opportunities And Challenges

    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.