Application Notes & Case Studies

  1. Oncology CRO Oversight FSP 1/2/2020

    To ensure compliance with the updated ICH E6 (R2) guidelines and to address internal capacity issues, a midsized biopharmaceutical Sponsor required qualified support to help ensure appropriate oversight of several large, global CRO providers. By embedding an oversight team within the Sponsor’s team Catalyst was able to alleviate a backlog of activities, while providing effective CRO oversight.

  2. Scaling A Solid Tumor Study 1/2/2020

    A mid-sized multinational biopharmaceutical company opted to internalize the study management and execution of their Phase Ib/II multicenter oncology program. As a result of positive treatment outcomes, patients continued in the trial for significantly longer than originally projected, creating a large data backlog that required source document verification. Read how strategies were deployed to obtain data currency and obtain management oversight to meet the program's expansion.

  3. Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies 12/26/2019

    The Vice President of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start 5 new clinical trials in 6 months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”

  4. Managing Clinical Ancillary Supplies At Global Scale 12/26/2019

    Clinical ancillary management expertise helps biopharma company oversee a large, global trial from start through finish.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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%