Application Notes & Case Studies

91. 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.

92. 510(k) Study Of Respiratory Diagnostic 10/22/2019

    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.

93. Complete Response: Lymphoma Trial A Success For Five Patients 10/2/2019

    A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma overcame patient recruiting challenges and has already succeeded beyond expectations in the form of five patients declared disease-free a year and counting while still three years from completing patient follow-up.

94. Leveraging Expertise To Exceed Immunotherapy Customer Goals 9/17/2019

    A biologics company needed a CRO with a dedicated oncology team to manage its Phase I, multi-center study to evaluate the safety and pharmacokinetic (PK) profile of an immunotherapeutic drug in subjects with advanced solid tumors. They found a clinical trial partner with oncology experience that could support protocol design and accelerate the start-up process to meet a quick first-patient-in (FPI) milestone.

95. Enrollment Surpasses Projections In International Psoriasis Studies 9/17/2019

    A leading global pharmaceutical company selected IQVIA Biotech to support four international Phase III biologic studies in moderate to severe psoriasis. This team was selected because of a proven patient recruitment process with a record of enrollment that could save the sponsor time and money. Successful patient recruitment strategies in 13 countries, where some are unfamiliar with advertising, surpassed enrollment projections.

96. Tailored Ultra-Low Temperature Labelling Environment Enables Trial Success 9/3/2019

    Clinical labelling is a function that has the potential to make or break a study, depending upon design and execution.  Incredibly specific and complex handling requirements associated with new medicines and biologics amplifies the challenge of compliantly packaging and labelling clinical supply. In our latest case study, we look at the complexities involved in labelling and kit assembly of an IP with very rigid, ultra-low storage and stability conditions.

97. AstraZeneca Takes An Innovative Approach To Trial Results Summaries 8/28/2019

    AstraZeneca made a commitment in 2015 to deliver PLS in advance of the European Medicines Agency (EMA) policy coming into play, says Julie Holtzople, Clinical Trial Transparency Operations Director. Many other sponsors have followed suit, taking a proactive approach to clinical trial disclosure and transparency. The statistics explain why. According to a 2017 (CISCRP) study1, 72% of the respondents said they want a summary of their results, 91% thought receiving results was really important, and 53% said they had never received a summary of results. “Our leadership made that commitment, and then we had to go figure out how to do it,” Holtzople says.

98. Phase 3 Bacterial Vaginosis Study 8/28/2019

    Ensuring that studies meet the business goals of sponsors and increase the range of treatment options available to patients and healthcare providers can be challenging when a trial must enroll subjects with a bothersome health condition and ask them to risk randomization to placebo. The project team in a study of an investigational treatment for bacterial vaginosis addressed such challenges and enabled the study to meet the sponsor’s goals.

99. Large PMA Study Of CRC Diagnostic 8/28/2019

    A study needed to enroll approximately 12,000 subjects and was also unique because it required subjects to self-collect samples at home. Read about the risk management and mitigation that Health Decisions utilized to keep the study on track.

100. Advancing Oncology Development With A Synthetic Control Arm Trial 8/7/2019

     A specialized biopharmaceutical company had a breakthrough therapy that had the potential to be first-in-class for a rare and aggressive hematological cancer and had shown great potential in earlier clinical trial. In many breakthrough treatment areas, where the patient population is small, or there is overwhelming evidence of efficacy at Phase 2, it has become common for drugs to be approved based on a pivotal single arm trial – however, this is not always optimal. Read how synthetic control offers a practical, effective way to leverage real-world evidence and has been applied in regulatory approvals.