Insights On Partnering

  1. Drug Pooling – A Strategy To Significantly Reduce Overages

    With the continued modernization and complexity of clinical trials in which a one-size-fits-all approach simply does not work it is important to understand the growing trend of drug pooling.

  2. Pooled Inventory And Just In Time Labelling (JTL) Meets Demand For Multiple Channels

    When a drug is required for both commercial and extended clinical trial use, this may cause strain on supply and demand operations. Discover how Almac Clinical Services used a pooled inventory strategy and Just In Time labelling (JTL) approach to maximize drug supply and minimize wastage.

  3. 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.

  4. 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.

  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. 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.

  7. 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.

  8. 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.

  9. The Role Of The CRO In Effective Risk-Based Monitoring

    A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.

  10. Replacing The TQT With Exposure-QT Response Study

    Revised study now includes the opportunity to demonstrate the cardiac safety of a new drug by utilizing Exposure-QT response study data in dose escalation and other studies.