Patient Data Reporting Featured Articles

  1. 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. 

  2. 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.

  3. 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?

  4. 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.

  5. You're A Small Biotech — How Should You Implement A Pharmacovigilance System? 1/28/2021

    When it comes to implementing strong PV practices at your company, there are a variety of components and capabilities to put in place. I’ve been on both the Big Pharma and biotech sides of this debate. With this knowledge in hand, I can help answer some of the commonly asked questions raised about PV best practices.

  6. Harmonizing Clinical Trial Content In A Post-Pandemic World 1/19/2021

    For clinical trial transformation to achieve its full potential, the structure and content of clinical trial documents must change to facilitate data transfer, content reuse, and predictability of information flow to support more efficient trial conduct by sites and sponsors.

  7. Best Practices For Implementing Decentralized Clinical Trials 1/12/2021

    While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.

  8. Tread Carefully Into Virtual Clinical Trials 12/21/2020

    With the COVID-19 pandemic’s impact on clinical trials in the U.S. and around the world, everyone is suddenly focused on virtual (decentralized) clinical trials. But if you plan to move your trials to a virtual model, at least one industry executive is recommending that you use caution when doing so. 

  9. ICH E6(R3) – Opportunities For Collaborative Alignment Between Stakeholders On eSource & RWE Priorities 12/8/2020

    During the 2020 Avoca Quality and Innovation Summit, an interactive brainstorming system was used during a workshop on ICH E6(R3) to gather industry executives’ insights about guidance that would more rapidly and effectively enable quality adoption of innovative trial designs and technology

  10. 3 Steps To Get A Virtual Clinical Trial Up And Running 10/20/2020

    Despite the existence of innovative technologies, they are only one piece of a complicated puzzle needed to successfully implement virtual clinical trial models. It’s critical that sponsors also consider these three key steps for achieving sustainable change in the bold, patient-centric move to virtual clinical trials.