Application Notes & Case Studies

  1. Optimizing Protocol Design And Enhancing Patient Enrollment

    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.

  2. Closed Loop Technology And Integrated Expertise Mitigates Risk

    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.

  3. Validating The Stability And Durability Of Labels After Thawing From Cryogenic Temperatures

    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.

  4. Sponsor Revamps Clinical Trials Website, Sees 13% Conversion Rate

    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.

  5. It’s About How The Social System Works, Not Just The Science

    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.

  6. Using LEAN Supply Chain Best Practice To Reduce The Risk Of Inaccurate Forecasting

    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.

  7. Scaling The Advanced Therapy Supply Chain

    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.

  8. A New Resupply Strategy Turns An Emergency Into An Opportunity

    Successful clinical trials require accurate demand forecasting, efficient distribution channels and a secure supply chain strategy. Find out how Almac Clinical Services helped one sponsor implement an optimized clinical supply strategy that resulted in an uninterrupted clinical trial and reduced costs.

  9. Ingenuity In Clinical Manufacturing Reduces Duration And Complexity For Phase III Trial

    Sharp Clinical Services provided a solution for a pharma clients that required a new oral formulation of their product. Multiple active ingredients created a complex manufacturing process combined with a requirements of 8 different batches required expertise of Sharp's Analytical and Formulation Development teams.

  10. inui Health Gets Results With EDC And eSource

    How a diagnostics startup drastically reduced timelines and costs, and easily shared data across dispersed sites.