Application Notes & Case Studies

  1. Gaining Efficiencies In The Monitoring Visit Report Process

    Ora, Inc. is a full-service research organization specializing in pre-clinical and clinical ophthalmic drug and device development. In this post, Ora discusses how they are using the monitoring reviewer comments feature in Vault CTMS to optimize trial processes.

  2. Maximizing Efficiencies With Effective Biologics Supply Chain Management

    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.

  3. Large Global Phase III Clinical Trial In Metastatic Colorectal Carcinoma (mCRC)

    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.

  4. Expanded Access For Delivery Of Treatment To Patients With Acute Adenovirus Infections Through A Named Patient Program

    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.

  5. Enrollment Goals Exceeded Through High Touch, High Tech For A Dermatology Study Of Adolescent Patients

    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%

  6. Rolling Start-Up Key In Global Observational Cohort Study For Patients With Psoriasis

    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.

  7. Mandatory Hub For Orphan-Designated Pediatric Therapy

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

  8. Agility And Expertise Combine To Overcome Late Stage Design Issues In Comparator Study

    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.

  9. Standardizing Process Characterization And Late Phase Development

    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.

  10. 510(k) Study Of Respiratory Diagnostic

    A sponsor had to conclude discussions with regulators and complete a variety of logistical arrangements and was left with an unusually brief period between study startup and the target period for sample collection – fall flu season. Read what risk management and mitigation strategies were used to ensure that site selection and startup happened quickly as to not miss flu season, what procedures were put in place so no samples were lost, other steps taken allowing the study to meet all of its goals.