Application Notes & Case Studies

1. Leading Medical Device Company Adopts Remote Source Review As New Standard 1/21/2022

   When the pandemic struck, a global medical device company – like so many other clinical trial sponsors – urgently needed a way to conduct remote monitoring with clinical trial sites. Find out the challenges and solutions in the available case study.

2. Profiling And Diagnosing Rare Disease Patients 1/20/2022

   While each disease affects a small patient population, as a category, rare diseases have a significant impact on patients, their families, and the healthcare system. Read this case study to find out how to profile and diagnose this group.

3. Strategic Clinical Trial Design Unlocks Innovative Funding Opportunity 1/18/2022

   A small biotech sponsor developing a new treatment for carcinoma and asked for assistance with their trial design. Working with a constrained R&D budget, the challenge was to gather the evidence in as cost effective a manner as possible and use a stage-gate approach for the funding. Explore the game plan and solutions in the available case study.

4. Optimizing Interim Analyses To Conserve Resources And Speed Strong Therapies To Market 1/18/2022

   Providing sponsors with an efficient way to consider larger numbers of design options can help to ensure that effective drugs have the best opportunity to demonstrate their value and reach the market in a timely fashion. 

5. Intelligent IRT Design Process Accelerates Digital Enablement At Sites 1/12/2022

   In this case study, learn about the challenges and solutions biopharmaceutical industry sponsors worked through to digitally enable sites and speed time to first-patient-in for COVID-19 therapeutic and vaccine trials.

6. Global CRO Embraces On-Demand Training And Achieves 100% Business Continuity During COVID-19 12/21/2021

   Before the COVID-19 pandemic, a leading global CRO used on-demand investigator training services in addition a traditional, in-person training program until almost overnight, face-to-face training became impossible. This case study describes how this CRO embraced on-demand virtual training services and achieved 100% business continuity amid the COVID-19 pandemic.

7. Using De-Identified Linked Real-World Data To Create An External Control Arm In Non-Small Cell Lung Cancer 12/16/2021

   A pharmaceutical company designed its Phase II study of a novel agent to treat metastatic non-small cell lung cancer driven by a rare subtype of EGFR genetic mutation. Learn the results in the available case study.

8. Global Device Company Takes Holistic Approach To Clinical Operations And Data Management 12/15/2021

   Learn how a global leader in medical devices replaced a complex, multi-vendor mix of outdated applications to accelerate their clinical trials process.

9. Streamlining Clinical Study Design: Lessons Learned From The Pandemic 12/15/2021

   Learn four ways that sponsors and CROs can be more nimble and accelerate their development programs.

10. COVID-19 Vaccine Development 11/29/2021

    A global pharmaceutical company sought to recruit African Americans to ensure a representative patient population for a U.S. COVID-19 vaccine trial. Find out the challenges and solutions in this case study.