GUEST COLUMNISTS

• Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product’s Labeling & Shipment

  When you assess other industries and companies like Amazon, Tesla, and Coca Cola, each has a commanding use of innovation and technology to ensure they have what they need, when they need it, and that how it gets from pick-to-pack is swift and error-free. Some clinical trials operatives may say, “but they are not required to follow the GMPs” or “we work in a highly regulated industry.” To those, I say: that's an excuse. 

• Co-Creating With Patients: The New Guide To Expanded Access

  Recently, Janssen Pharmaceutical Companies had the privilege of working with patients and advocacy groups to co-create a resource about expanded access for patients and caregivers. This article shares that story and describes how patients will benefit from the resource.

• How AstraZeneca’s Clinical Trials Procurement Team Adapted To The Pandemic’s Demands

  The pandemic has tested AstraZeneca’s Global Operations organization to ensure clinical trials continue. As a function, procurement plays a key role across this supply chain, with a strong emphasis on assuring supply of product on time and with solid service by third-party suppliers to respond to any shifts in demand. Here's how AstraZeneca's procurement team successfully adapted.

• What Is Scientific Research Misconduct & Fraud In Clinical Research?

  What does scientific misconduct and fraud truly mean in the context of clinical research? And what are the ramifications for those at fault? This article provides an overview as well as common findings from the DOJ and FDA.

• Decentralized Clinical Trials: Does Your Strategy Include These Facets?

  Decentralized clinical trials have increased in response to the COVID-19 pandemic, yet this may be due to a convergence of two factors already in play: our reliance on the use of digital health technologies and a move by the FDA and industry toward patient-focused, real-world clinical trials that leverage the technological advances already available.

• 3 Strategies To Engage With Patient Advocacy Organizations

  Patient communities can offer extremely valuable insights to help ensure the success of your clinical development program. Larger companies have a corporate function with professionals who are well versed in engaging these groups, but how do small companies take that first step to introduce their company to a new patient community? Here are 3 successful strategies.

• Best Practices for Risk Assessment of GxP Vendors and Inspection Readiness

  Requirements for risk management in clinical trials are outlined in GCP (R2) and provide you, as the sponsor, with the main steps for risk management in your studies. The implementation will vary from vendor to vendor depending on their delegated duties and functions. In addition to that, there are three other important considerations.

• Cell And Gene Therapies: Solving Six Challenges

  This past year has seen remarkable progress in the growth of cell and gene therapies. While advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell and gene therapies for a range of diseases and uses, the go-forward path will require planning around these six major issues.

CLINICAL TRIAL WHITE PAPERS

• Avoid Critical Findings In Your TMF - A Review Of MHRA Findings

  In clinical research, there is great emphasis on the TMF being inspection-ready at all times. However, regulatory agencies still encounter critical findings in the TMF during inspection. The MHRA recently published their annual GCP Inspections Metrics Report covering metrics from April 1, 2018, to March 31, 2019, which include what issues were found during inspections. In this white paper, we take a look at the most common TMF issues and how to avoid them.

• Strategic Considerations For Regulatory, Operational, And Commercial Success In Dementia Research

  11/30/2020

  Given the burden that caring for individuals with dementia places on both the health care system and caregivers, research and development efforts now extend beyond Alzheimer’s disease to explore a mosaic of syndromes, each of which presents unique and significant challenges, in part because so much remains unknown about the pathophysiology, clinical presentation, and course of these conditions.

• Complete Buyer's Guide To The Modern Electronic Trial Master File (eTMF)

  9/8/2020

  Implementing an eTMF is critical for Sponsors and CROs that want to reduce burden, increase study capacity, and enable more trials. However, many organizations are not equipped with a modern solution to realize the full benefit and future proof operations. This guide serves as an in-depth overview of how a modern eTMF solution can impact your organization and the steps you can take to prepare.

• Improve GI Data And Patient Engagement With GI ePRO/eCOA

  2/10/2021

  Current trial solutions rely heavily on electronic clinical outcome assessments (eCOA) to improve data quality and integrity. Eligibility decisions based on data  derived through calculations based on compliance and complex scoring are increasingly common. Further, the accelerating complexity of GI protocols has far outpaced the eCOA industry in simplifying trial solutions for that complexity. This paper describes the complexity of GI trials in detail and shows a solution that is designed to overcome their significant, but typical, challenges.

• The Need To Recruit Better: Understanding The Barriers That Keep Patients From Participating In Clinical Trials

  8/17/2021

  Much has been written and discussed concerning the challenges around enrolling enough patients in clinical trials. Poor recruitment and insufficient enrollment stretch study timelines, add costs and can cause studies to fail outright before they can even begin. Some formidable barriers exist that work to keep eligible and interested patients out of clinical trials. By understanding these barriers, we can begin the necessary work to remove them.

• The Tale of Two Trials

  11/9/2020

  The debate surrounding best practices for patient management and data collection during clinical trials is ongoing. In this paper we take an in-depth look at the benefits and drawbacks of the traditional, paper-based outcomes assessment method, as well as the advantages of the emerging electronic clinical outcomes assessment (eCOA) solutions.