Application Notes & Case Studies

  1. Evidence Generation Strategic Partnership For Heart Failure Studies 12/9/2019

    Read how a pharmaceutical support services company helped a large pharmaceutical company manage a portfolio of 5 heart failure studies, with over 500 investigator sites and 7,000 patients, to accompany an evidence generation program for a new product launch.

  2. Gaining Efficiencies In The Monitoring Visit Report Process 12/3/2019

    Ora, Inc. is a full-service research organization specializing in pre-clinical and clinical ophthalmic drug and device development. Learn how Ora implemented monitoring reviewer comments with Veeva Vault CTMS to optimize their trial processes.

  3. Maximizing Efficiencies With Effective Biologics Supply Chain Management 12/3/2019

    Operating biologics-based clinical trials presents several unique challenges and the cost involved in developing these pioneering drugs leaves little margin for error. Download this case study to learn how Almac’s supply chain experts helped one sponsor deliver operational efficiencies and cost-effective medication management for a global Phase III trial.

  4. Large Global Phase III Clinical Trial In Metastatic Colorectal Carcinoma (mCRC) 11/25/2019

    UBC was tasked with managing a large global phase III clinical trial in patients with mCRC refractory to standard chemotherapies. Read how patient enrollment was completed 3 months ahead of schedule and database lock 3.5 months ahead of schedule.

  5. Expanded Access For Delivery Of Treatment To Patients With Acute Adenovirus Infections Through A Named Patient Program 11/25/2019

    For sponsors, there are numerous operational logistics and regulatory approvals required in order to provide access to their medications through an EAP or CUP. In this case study, UBC deploys a global Expanded Access Program (EAP) to ease the burden on the sponsor and rapidly provide treatment to patients.

  6. Enrollment Goals Exceeded Through High Touch, High Tech For A Dermatology Study Of Adolescent Patients 11/25/2019

    UBC was selected by a large biopharmaceutical company to manage a U.S.- based Phase IV randomized, placebo controlled clinical trial of patients with severe acne. As a result of UBC’s innovative services, not only was the enrollment goal achieved, but it was exceeded by 60%

  7. Rolling Start-Up Key In Global Observational Cohort Study For Patients With Psoriasis 11/25/2019

    A large biopharmaceutical company needed to manage a 5 year observational cohort study for patients with moderate-severe psoriasis who are initiating or switching to a new biologic. Read how UBC successfully managed global observational study with customized service offerings.

  8. Mandatory Hub For Orphan-Designated Pediatric Therapy 11/25/2019

    UBC successfully provided Hub services to ease the barriers to access and simplify a very complex treatment initiation in pediatric patients suffering from SMA.

  9. Agility And Expertise Combine To Overcome Late Stage Design Issues In Comparator Study 11/22/2019

    Encountering unforeseen problems when sourcing a comparator for an investigational product can severely impact the success of a clinical trial. Download this case study to learn how Almac Clinical Services helped one sponsor overcome late stage design issues through successful sourcing and procurement of a suitable alternative comparator.

  10. Standardizing Process Characterization And Late Phase Development 11/18/2019

    Process characterization is an important step in the overall journey of product development. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.