Articles, App Notes, Case Studies, & White Papers

1. Single-Arm Trials Use Real-World Evidence For Rare Disease Drug Development 3/1/2022

   In rare disease product development, where a placebo control group may not be an option, a single-arm trial can be a successful approach. Gain insight into the regulatory considerations for single-arm trials.

2. Do CROs Need To Reinvent Themselves In 2025? 3/21/2025

   Facing economic pressures, regulatory changes, and technological advancements, CROs must redefine their value propositions and discuss the need for reinvention in 2025 to accelerate into the future.

3. Better Data, Better Decisions 11/17/2023

   Learn how to achieve greater certainty in clinical trial financial management by leveraging adaptive, accurate, and defendable fair market value.

4. Tackling Feasibility In Rare Disease Clinical Trials 1/13/2025

   Rare disease clinical trials face distinct challenges, but the right data strategy can offer a transformative approach to addressing complexities and enhancing enrollment.

5. Solutions For The Strategic Assessment Of Clinical Data In Trial Operations 8/29/2017

   Achieve clinical trial operations excellence using this an innovative solution that gives clinical operations organizations the unprecedented ability to reduce the time, cost, and risk of running clinical trials while accelerating time to market for products across the entire portfolio of clinical candidates.

6. One Day, Clinical Trials Will Represent The Real World 2/12/2024

   What needs to happen for RWE to reach its full regulatory potential? We discussed this with industry leaders during the One Day Summit, and here are some key takeaways.

7. Why ePROs In Oncology Are Perfect For Capturing The Patient's Voice 5/15/2025

   Recently released FDA guidance showcases why electronic patient-reported outcomes (ePROs) are ideal for capturing the “voice” of the patient. See how ePRO eases oncology trials.

8. The Hidden Cost Of Preferred Vendors 10/21/2025

   Familiar vendors offer comfort — but at the cost of innovation, fit, and fresh thinking. Ease shouldn’t outweigh excellence when selecting partners for your clinical trial.

9. Key Changes For Computerized Systems And Electronic Data 5/24/2023

   Explore several modifications introduced in the updated guidelines by the European Medicines Agency regarding computerized systems and electronic data in clinical trials.

10. Productivity Hacks For An Effective RFP / Clinical Trial Vendor Selection 7/1/2025

    Starting a new clinical study requires careful vendor selection and these practical, actionable steps to enhance your selection process and ensure long-term partnership alignment.