Patient Data Reporting Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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?

  7. 3 Clinical Trials Lessons The Pandemic Taught Us 6/29/2021

    Coming off the COVID-19 crisis, many of the creative solutions implemented because of the pandemic may actually improve previous work processes and should become part of standard practice going forward. Here are the three new approaches that you should consider for your next protocol. 

  8. How Clinical Execs Can Embrace Technology (& How To Find Activated Patients Who Do, Too) 5/18/2021

    How can we make the clinical trial process more efficient and effective? By embracing technology (for example, AI and machine learning) and finding patients who embrace technology, too. The former deputy chief medical officer for the American Cancer Society shares his thoughts.

  9. How To Navigate Compliance With FDA's 21 CFR Part 11 4/7/2021

    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?

  10. What Is Driving The Adoption Of EDC Applications? 3/19/2021

    In December 2020, Industry Standard Research (ISR) released the 4th edition of its EDC Market Dynamics and Service Provider Performance report. I spoke to Sherry Hubbard-Bednasz, market research director at ISR, for some insights into the report and its findings.