Industry Insights

1. Mobile Devices Pave The Path For Clinical Research Evolution 5/11/2012

   Clinical trial sponsors looking to stay at the forefront of efficiency and accuracy should consider whether they are making the best use of the growing trend of access to clinical data on mobile devices. From the secure sharing of electronic patient reported outcome (ePRO) data, to creating more flexible clinical data management, mobile technology has the potential to improve processes across the clinical research process. By Rick Morrison, CEO, Comprehend Systems

2. Tablet Consistency And Punch Length – A Pragmatic Perspective For European Manufacturers 10/7/2025

   Tablet consistency relies on a balance of formulation, press mechanics, and tooling. Learn why punch length tolerance is often overstated and what other critical factors truly drive quality and uniformity.

3. Transparent Pricing In Bioanalysis: A Feature, Not A Bonus 3/9/2026

   Unclear CRO pricing leaves small biotechs vulnerable to budget swings. Transparent, itemized costs cut financial risk, sharpen planning, and build trust by setting expectations from the start.

4. Successfully Navigating Opportunities With On-Body Delivery Systems 4/23/2026

   Drawing on insights from the global regulatory landscape, industry trends, and direct feedback from customers, Dr. Di Wu addresses some of the most frequently asked questions about on-body delivery system requirements.

5. FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address 3/17/2026

   For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

6. Understanding Medical Diagnostic Method Patent Eligibility 7/31/2019

   Until this area of unsettled law is more fully developed, it will be important to include practical implication details in medical diagnostic patents to maximize the flexibility to claim inventions in multiple ways.

7. Can Real-World Evidence Transform Healthcare? FDA Indicates Yes 11/19/2021

   Health policy experts have talked excitedly about the potential for real-world evidence (RWE) to transform healthcare delivery and drug development for years, but the regulatory framework has remained in a state of infancy. Now, we're starting to see the FDA’s efforts in advancing RWE into its toddler growth spurt.

8. Bioinformatics: A Vital Precursor To Successful Biomanufacturing

   Review a global approach to bioinformatics supported by four pillars: derivation of sequence-based features, building structural 3D models, exploring molecular flexibility, and analysis of the complex multi-dimensional data.

9. What Regenerative Medicine Manufacturers Have Been Waiting For 11/9/2023

   It's not revolutionary, say two FDA experts. However, the agency's new voluntary consensus standards program for regenerative medicine therapies responds to an industry clamoring for standardization. With standards that everyone agrees on, sponsors can save massive amounts of time designing protocols, and regulators can save time reviewing them.

10. Critical Considerations In Outsourcing Nanotechnology Drugs 3/27/2019

    If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”