Patient Data Reporting Featured Articles

  1. Digitally Enabled Clinical Trials: A Practical Guide 12/2/2021

    Undoubtedly, digital trials will stay as the world coexists with the pandemic, so it is essential for both sponsors and sites to be early adopters. This article will examine the benefits and challenges of digital clinical trials and identify key considerations for sponsors and sites as the world continues to navigate the new normal.

  2. Our Lessons Learned In Implementing AI In Clinical Development 11/16/2021

    Taiho Oncology had multiple sources of clinical data that weren't being leveraged to their fullest potential. When they implemented an AI-powered data analytics platform, they obtained a single source of truth for data analysis and reporting, and they learned a number of valuable process- and people-oriented lessons along the way.

  3. Clinical Trials: Envisioning A Future Where Technology Expedites Your Investigational Product's Labeling & Shipment 10/14/2021

    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. 

  4. Co-Creating With Patients: The New Guide To Expanded Access 10/12/2021

    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.

  5. Traditional Trials Are Dead – Virtual Trials Are The Future 9/3/2021

    It’s no secret that decentralized clinical trials, also known as virtual trials, are one of the hottest technology trends in the clinical space. Although this trial model has been touted by vendors for many years, it took the emergence of the COVID-19 pandemic in 2020 to get many companies scrambling to implement the new approach.

  6. Best Practices For Setting TMF Expectations With Your CRO 8/12/2021

    Developing a strong relationship and setting up-front expectations with your chosen CRO are critical keys to success in clinical studies. While the RFP process will assist in framing the contractual relationship between sponsor and CRO, it is unlikely to outline your detailed operational expectations. Follow these best practices to avoid confusion and resentment, and to make sure your CRO will satisfy your expectations.

  7. A Proactive Approach To Preparing For The Release Of ICH E6 8/5/2021

    Approximately 25 years ago work began on a document intended to revolutionize and improve the efficiency of new drug development. The document, dubbed ICH E6, was intended to provide guidance for clinical trials conducted around the world. ICH E6 is quickly becoming a reality and sponsor companies need to be prepared for it.

  8. 4 Imperatives For Updating Our Clinical Quality Systems Approach For 2022 Pharma 7/29/2021

    The clinical quality management systems approach developed 20 years ago is not sustainable in the today’s industry because we've seen dramatic industry changes in outsourcing, remote monitoring, the use of electronic systems in clinical research, and more. But how do we update our approach for 2022 pharma? This article examines 4 imperatives, including how to accomplish them.

  9. Otsuka Believes Digital Technologies Will Drive Patient Outcomes 7/29/2021

    While other companies scrambled to implement clinical trial-related technology to deal with the pandemic, Otsuka was an early adopter of tools such as eCRF and eConsent.  Christoph Koenen, EVP and chief medical officer at Otsuka Pharmaceutical Companies (U.S.) explains how digital technologies will continue to drive patient outcomes.

  10. eClinical Systems Post-COVID: Have You Realized Your Digital Transformation? 7/13/2021

    When the pandemic started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Now, as the U.S. is in a summer characterized less by COVID and more by time spent with family and friends, are we willing to face COVID’s hard lessons?