Application Notes & Case Studies

  1. Consolidating IRT And Clinical Supply Management To Save Time And Costs
    3/18/2019

    It is difficult to quantify the soft costs of managing a clinical trial. One factor guilty of contributing to spiraling soft costs is time. Download Almac’s case study that demonstrates how Almac’s One Clinical Trial Supply Solution helped a pharmaceutical company streamline its clinical trial operations, resulting in time and cost savings.

  2. Case Studies In Supply Chain Management: Getting It Right From The Start
    3/15/2019

    Consistent management and communication are the keys to success when managing the supply chain of any advanced therapy clinical trial. In this article, we’ll review two case studies that demonstrate the importance of supply chain management by focusing on scaling up for commercial distribution and on packaging challenges within a cryogenic environment.

  3. Advancing A Diabetes Multi-Registration Program
    3/11/2019

    A large pharmaceutical company asked Covance to support their studies for a diabetes Phase III program specifically to register a drug to treat Type 2 Diabetes. Read how Covance utilized its rich central laboratory services database and helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics.

  4. Optimizing Protocol Design And Enhancing Patient Enrollment
    3/8/2019

    An emerging biopharmaceutical company was designing a Phase II trial in patients who had Type 2 Diabetes, Stage 3 chronic kidney disease (CKD) and macroalbuminuria. They were uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid subject recruitment. Read how LabCorp de-identified clinical laboratory data helped evaluate the protocol feasibility and the overall design of the study while also making an adjustment in eligibility criteria was forecast to double the eligible patient pool – without impacting study endpoints.

  5. Closed Loop Technology And Integrated Expertise Mitigates Risk
    3/4/2019

    Discover how Almac helped one pharmaceutical company streamline processes and remove risk from their multiple clinical trial applications while maintaining data integrity with One Unified Clinical Trial Supply Solution.

  6. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures
    2/26/2019

    One important element of working in cryogenic temperatures involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. The following study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.

  7. Sponsor Revamps Clinical Trials Website, Sees 13% Conversion Rate
    2/25/2019

    A Top 20 sponsor, eager to be more patient centric, decided to build a new, dedicated clinical trials website. The site is mobile friendly, has a robust search function, and uses simple navigation and language. Site metrics reflect increased traffic, engagement and conversion.

  8. It’s About How The Social System Works, Not Just The Science
    2/21/2019

    After a failed attempt from their first CRO, this manufacturer turned to Premier Research to successfully recruit and retain 24 patients for a Phase I proof-of-concept study of inflammatory bowel disease.

  9. Using LEAN Supply Chain Best Practice To Reduce The Risk Of Inaccurate Forecasting
    2/20/2019

    When one pharmaceutical sponsor was faced with unreliable demand forecasts, Almac Clinical Services helped implement a LEAN supply chain approach to ensure clinical sites received the right drug quantities needed to support all patients in a global Phase III trial.

  10. Scaling The Advanced Therapy Supply Chain
    2/13/2019

    Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.