Application Notes & Case Studies

  1. Data Standardization For Late Stage Development And Periapproval Studies 7/10/2019

    Now more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources. Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited.

  2. Merck Transforms Trial Efficiency With Strategic eTMF Initiative 7/3/2019

    Merck has embarked on a company-wide mission to update its TMF processes and technology to ensure greater quality documentation and timeliness, while making it easier for study personnel to reach critical milestones.

  3. Critical Milestones Achieved Ahead Of Schedule In Lung Cancer Study 6/28/2019

    Learn how IQVIA Biotech helped a biotechnology company reach critical milestones as it prepared to launch an international Phase III clinical trial for its investigational ALK inhibitor in patients with non-small cell lung cancer.

  4. Managing Risks To Time Critical Product Imports At Clinical Supply Depots 6/11/2019

    Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.

  5. Innovative Clinical Supply Solutions - Cold Chain 6/11/2019

    With our team of packaging experts and extensive cold chain capabilities, this case study discusses the creation of a custom packaging and distribution solution to meet this client’s unique needs. Through our partnership, the product was successfully packaged in sufficient quantity and on time for the Phase I trial.

  6. A Solution To Ensure Quantity & Quality Of The Excipient Polysorbate-80 In Drug Formulations 6/10/2019

    Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.

  7. Comparing Continuous And Batch Processing In Downstream Purification 6/10/2019

    Current state-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products including monoclonal antibodies, recombinant proteins, and other biological modalities. Though upstream fed batch and perfusion bioreactors unit processes are relatively mature, downstream process unit operations are less mature. In this case study, Catalent compared the productivity of purifications running in batch versus continuous mode.

  8. Customized Labelling Solution Delivers Seamless Trial 5/24/2019

    Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution. A function that was once seemingly on the periphery of clinical trial management has now taken on a new level of significance with increasingly complex labelling requirements. This case study highlights the complexities involved in label design and execution and how Almac worked with one sponsor to identify and rectify a flawed design to ensure a seamless trial, an improved patient experience and enhanced overall trial performance.

  9. Putting Patients First By Introducing Supply Chain Visibility And Efficiency To Investigator Initiated Trials 5/14/2019

    Investigator Initiated Trials (IITs) play an important role in helping sponsor companies better understand their drugs. However, managing these studies presents unique and complex clinical supply chain challenges. Download the case study to find out how Almac Clinical Services helped one biotechnology company effectively manage drug supply for multiple IIT programs.

  10. Direct-To-Representative Sample Distribution Services 4/30/2019

    One particularly effective approach to promote prescription drug products is to have pharma sales reps ‘hand carry’ samples to the health care practitioners within their territories.