Application Notes & Case Studies

  1. Harnessing Effective Cold Chain Capability To Absorb The Impact Of Mid-Study Protocol Changes
    7/15/2019

    The most successful clinical trials have one thing in common: sponsors never stop looking for ways to improve processes that support the core objective of delivering safe, compliant investigational product to patients, when and where they need it. Read Almac’s latest case study to learn how they helped one sponsor effectively manage a drug formulation change mid-trial without study interruptions or patient impact.

  2. Midlantic Urology Associates Introduces Added Convenience For Patients With Rideshare Program
    7/15/2019

    Midlantic Urology Associates had been employing a single driver for all participant pick-ups. This proved to be inefficient and unsustainable, so they began utilizing taxis. This alternative was costly and unreliable – there had to be a better way. ClinCard’s integration with Lyft has not only improved the experience for patients and study coordinators but has also helped with recruitment as new patients are enrolling in the study as a result of this added convenience.

  3. Medical University Finds Solution To Track Participant Remuneration
    7/15/2019

    Concern ensued across the Medical University of South Carolina (MUSC) research faculty and staff when they received notice that departments would need to somehow track and sum all their petty cash, Walmart and Target gift cards, VISA cards and checks issued through Accounts Payable (as there was no institutional research policy standardizing a single type of remuneration payment for clinical research participants). A fellow academic medical school recommended ClinCard by Greenphire which ended up being the perfect solution.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.