Application Notes & Case Studies

  1. The Critical Importance Of Comparator Temperature Excursion Management

    Today, comparator procurement is one of the most expensive components of clinical trials. This cost can take on further meaning as the risk of a temperature excursion or a loss of drug due to time out of environment can result in additional charges and even delays in the trial.

  2. Quality Of Recruited Patients Vs. In-Practice Patients

    Clinical trial data are the lifeblood of every submission, and it’s no wonder that clinical trial teams might be wary of trial participants who are not sourced by the research sites themselves. So the question is: Is there a difference in quality between externally recruited and in-practice patients? We have analyzed the data and the results are in.

  3. Patient Enrollment For Global Diabetes/CVO Study

    This seven-year outcomes study was critical to the success of a compound that is expected to build on the sponsor’s leadership position in diabetes care. Because of the study’s importance, as well as the costs associated with this multiyear program, keeping enrollment and study timelines on track was of paramount importance to the sponsor.

  4. Patient Enrollment For Global Gout Study

    This phase III global program, involving four protocols and approximately 300 sites, was critical for a sponsor striving to make its compound the leader in a potential $1B gout market by 2018.

  5. Solving The Challenge Of Comparator Drug Procurement

    A leading pharmaceutical company approached Fisher Clinical Services to assist them with obtaining comparator study medication for a global Phase III program. The trial was focused on an infectious disease and would involve 25 countries across 130 investigator sites.

  6. Addressing Translation And Approval Challenges Within The Clinical Trial Labeling Process

    A major global pharmaceutical Sponsor was seeking a new approach to enhance the efficiency of their supply chain process including their label and translation management approaches.

  7. Alternative Logistics Realizes Efficiencies For Clinical Studies In Asia Pacific Region

    Our client, one of the top major pharmaceutical companies with research priorities aligned to significant global health needs – diabetes, heart disease, cancer and mental health - had a high number of studies already in progress in the Asia Pacific region.

  8. Accessing Patients In Remote Locations Presents Challenges For Ambitious New Trial

    Our client, one of the top major pharmaceutical companies approached us for guidance on how to run an ambitious clinical trial in the Asia Pacific region; a trial involving 10+ countries, 74+ sites with 400+ shipments across the region.

  9. Pre-Filled Syringe Assembly - Ensuring Container Integrity

    A global pharmaceutical company was developing a large molecule drug for a gastroenterology indication and wanted to set up an automated process for assembling pre-filled syringes without compromising container integrity.

  10. Synergy Chooses ClinCapture

    In 2007 Synergy opened a Clinical Data Management Department with local, low-budget projects and decided to implement an open source EDC solution as a clinical data collection tool. This tool required installation and validation every time a new project was started. When the number of projects started to multiply, management quickly realized they had two options: expand their IT resources to support data management applications or outsource. They chose the second option so they had to find a cost-effective, pay-as-you-go, cloudbased EDC solution which would allow them to move their current EDC projects without interruption.