Patient Data Reporting Featured Articles

  1. How Blockchain Can Empower Patients And Improve Clinical Trials 8/4/2023

    Blockchain is far bigger than cryptocurrency. It's a data encryption technology that can not only strengthen existing clinical systems, but also (and most importantly) empower patients by giving them more control and ownership of their clinical data.

  2. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

  3. Boehringer Ingelheim Implements One Medicine Technology Platform 12/8/2022

    For years, Boehringer Ingelheim operated with a system comprised of best-of-breed solutions from different vendor companies. After carefully evaluating the technology environment, the company decided to move from best-of-breed solutions to an end-to-end product development platform.

  4. Life Sciences RIM: Modernization & Moving Ahead 9/28/2022

    Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.

  5. What's In Store For EMRs After The Pandemic? 5/9/2022

    During the pandemic, our industry has realized that electronic medical record (EMR) systems needed some changes. This article discusses the new EMR specifics, including improved operability, advanced analytics, and smooth integration with diverse systems.

  6. Best Practices For Designing Patient-Centric Decentralized Clinical Trials 4/12/2022

    Decentralized clinical trials are not universally applicable to all phases of a trial and therapeutic areas. The recommendations in this article may bring decentralized and hybrid trials to a more tangible and realistic view and, in essence, make them more executable.

  7. 2021 Clinical Research Site Survey Findings: A Year In Flux 3/24/2022

    Since its inception in 2012, the Society for Clinical Research Sites (SCRS) has conducted an annual survey of clinical research site community members to derive insights, reveal trends, and ensure the site perspective is represented. This article summarizes the 2021 survey's findings.

  8. Best Practices For EDMS Implementation For Virtual & Early-Stage Pharmaceuticals 12/14/2021

    Since the beginning of the pandemic, the clinical trials industry has rapidly adopted electronic documentation management systems (EDMS). However, for virtual and early-stage pharmaceuticals, an EDMS can pose several challenges. This article highlights the key factors that you should consider when evaluating the adoption of an EDMS to avoid the most common pitfalls.

  9. Data Interoperability: The First Step To Leverage ML & AI In Clinical Trials 12/9/2021

    The first hurdle we need to overcome to leverage machine learning and AI in clinical development is data interoperability. We must break data silos, find a way to make the data points communicate with one another within the drug development continuum, and analyze each data point in its full context. This article also delves into the importance of metadata and the differences between different data formats.

  10. The State of Real-World Data – And Where We Go From Here 12/7/2021

    There are many questions that a lot of clinical executives have about real-world data (RWD) and real-world evidence. There are questions about the quality and completeness of the data, the new digital apps generating data, patient privacy, its use in synthetic control arms, and the impact it might have on the patient diversity problem.