GUEST COLUMNISTS

• How to Optimize Success in Clinical Trials of Antidepressants

  In order to bring promising therapies safely, effectively, and expediently to the millions of individuals who suffer from major depressive disorder, we need to reevaluate learnings from the past few decades to overcome the challenges in design and conduct of clinical trials for antidepressant drugs.

• Diverse Patient Populations In Clinical Research: 3 Steps For Success

  While the clinical trials industry has made incredible strides raising awareness among the broader general population, as we’ve witnessed firsthand amid the ongoing COVID-19 pandemic, there remains a persistent lack of representation in clinical research among diverse communities. How do we address this?

• Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise

  With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

• Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare

  The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more! Here's what you can do to position yourself for success.

• Is Your Site Selection Process Optimized?

  Our current approaches for assessing potential sites is not keeping pace with the increase in trial complexity observed across the industry. By adjusting our strategy during this critical state of a trial, we take a step toward improving overall clinical trial performance and ultimately advancing treatments more quickly and efficiently.

• How To Navigate Compliance With FDA’s 21 CFR Part 11

  21 CFR Part 11, the FDA's regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance at CROs and pharma companies. How can you ensure compliance with this regulation?

• FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch

  The FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.

• The 3 Secrets To Becoming an Effective Leader In Clinical Research

  Experience in clinical research provides a solid foundation, which better positions you to launch your career into management- and executive-level roles. However, you will move away from operational execution and will be called to develop the skillsets and level of confidence required to lead and guide teams. What are the 3 skillsets to understand, develop, and refine your journey?

CLINICAL TRIAL WHITE PAPERS

• Risk Based Quality Management (RBQM) - A Collaborative Approach To Holistic Clinical Trial Oversight

  Developing, executing, and overseeing clinical trials is a complex process. This paper shares perspectives that will assist sponsor organizations in the creation of a RBQM system in partnership with their CROs and vendors. When a shared, proactive plan is established, sponsors and CROs/vendors can then tailor their oversight strategy to support improved quality and safety of clinical trial execution.

• Making The Most Of Clinical Trial Data

  5/22/2019

  To control costs, improve efficiency, and successfully bring more drugs to market—life-changing, life-saving drugs—pharma and biopharma companies need to follow the lead of the financial industry and forward-thinking health systems. Here, we discuss how a data-driven approach to clinical trials—from patient recruitment to post-regulatory approval—can put an end to missed deadlines, failed studies, and wasted time and money.

• The Next Generation Of Trial Master File Systems

  11/20/2020

  The next generation of eTMF systems are coming into their own. They use Artificial Intelligence and Natural Language Processing (NPL) to improve efficiency, preserve one version of the truth, and maintain audit readiness. The following paper covers the current state of eTMF technology and the future level of functionality that users can now expect.

• Improving Regulatory And Operational Performance In Orphan Drug Development

  7/30/2019

  The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.

• Facilitating Patient-Led Research: How Increased Data Access Can Increase Patient Enrollment And Engagement

  2/4/2021

  Having access to millions of patients offers an opportunity to provide study designers the ability to transform clinical trials. After all, ready access to such an enormous and diverse patient population should facilitate enrollment in an unprecedented way, while enhancing and supporting patient engagement like never before. This paper shares how a robust patient database is one critical key that impacts multiple facets of a trial, leading to more successful outcomes that put patients at the center of research.

• Factoring The “What Ifs” Into Supply Forecasting

  8/24/2020

  Growing urgency in the biopharmaceutical industry to speed new products to market leads to greater appreciation for supply forecasting as a strategic and highly complex success factor. Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.