GUEST COLUMNISTS

  • How AI/ML Is Helping Clinical Researchers Investigate Alzheimer’s

    Like many cognitive conditions, Alzheimer’s disease can cause changes to a person’s speech and language. Artificial intelligence (AI) and machine learning scientists are working on automating speech assessments to detect the disease earlier and improve understanding of the efficacy of novel treatments. 

  • 3 Key Factors For Selecting Clinical Data Providers

    As the volume and availability of clinical data have increased, so has commercial interest in clinical data. The wide array of data-sharing initiatives makes it difficult for pharma companies to identify and select the right source or sources of data to deliver on their needs. Here are three key factors to consider as you select and engage with clinical data providers.

  • Your Guide To Harnessing Clinical Trial Sensor Data Better

    Technological advances in wearables and sensors are speeding the development of digital measures and endpoints. This sensor data is often in native formats unique to each sensor technology and in proprietary clouds owned by the manufacturer. To address this challenge, the Digital Medicine Society released a set of open-access toolkits to support the successful scaling of sensor data to drive better clinical decisions.

  • Online Resource Launched To Ease Clinical Trial Participation Fears

    Studies have shown that patients are eager to participate in clinical trials, but they lack the resources to address their fears. Fear remains the main barrier to patient participation. Earlier this year, an independent start-up launched an online resource for patients to access information they need to ease their fears.

  • Clinical Research Sites Share Cash & Workforce Shortage Concerns

    As the industry faces unprecedented macroeconomic issues, including substantial staffing challenges and inflationary pressures, resources are desperately needed to support clinical research sites and studies. As a sponsor company, consider ways to help sites right now: Can existing budgets be adjusted? If not, what other solutions may be available? 

  • 3 Strategies For Optimal Oversight Of Your Outsourcing Partner

    Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.

  • Tips For Clinical Trial Sponsors To Cultivate Meaningful Relationships With Sites

    Sponsors can influence site choices and work better with them by creating a positive sponsor-site relationship from the onset, which includes making design decisions that consider the patient perspective and making execution decisions that alleviate common operational challenges and reduce burden on sites. Here's how.

  • Designing A Phase 3 Clinical Trial In Rare Dermatology: Lessons Learned

    Rare dermatologic disease R&D is growing at a much faster rate than other fields in dermatology. Even before the data readout from our Phase 2b study, we began formulating several possible Phase 3 trial designs and asked scientific, operational, and regulatory questions. Here are our lessons learned.

CLINICAL TRIAL WHITE PAPERS

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • Tau Pathology Clinical Trial
    4/28/2022

    Working in close collaboration with the manufacturer of a novel treatment for Progressive Supranuclear Palsy, MRN played a major role in delivering Home Trial Support (HTS) for 79 patients in several different countries.

  • Rapid Launch Of A Phase I COVID-19 Vaccine Trial
    4/28/2021

    At the onset of the COVID-19 pandemic response, our current client needed help to kick off a phase I vaccine trial. The sponsor had identified sites and patients and the gating factor was to get the clinical trial database built quickly in order to start enrollment and randomization. Learn how we helped our client design and launch their clinical trial database in two weeks' time, with patient randomization beginning the day of launch.

  • No Shortcuts: Two Pathways To Building A Future For Huntington’s Disease Research
    11/16/2021

    One of the tenets of clinical research is that findings often result in more questions than answers. For Huntington’s disease, the journey toward understanding and treatment continues to be a methodical one. Dr. Ole Isacson highlights two pathways to ongoing research for this rare disease.

  • An Evolving Biologics Landscape And Driving Innovation And Opportunity
    12/7/2021

    The biologics segment is expanding quickly, with respect to both the level of investment and number of new startups. Explore a more collaborative investment model, the development of novel devices and delivery technologies, and a natural evolution in the CDMO space.

  • Pharma Sponsor Enlists Cenduit IRT To Rescue A Multi-Country, Multi-Site Oncology Study
    2/24/2021

    After go-live, the sponsor learned its study did not fit the existing IRT solution, affecting data quality, timelines, and drug supply shipments. The legacy system’s medication management algorithm could not support the required flexibility in the supply chain. The trial included an adaptive cohort design. Read how Cenduit delivered a high-quality study achieved through innovation, close client collaboration, and expert project management.

  • EU’s New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?
    5/16/2022

    The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.

CLINICAL LEADER CONTENT COLLECTIONS

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The articles in this e-book all relate to the challenge of CRO selection. We hope you enjoy them and learn from the insights contained in them.

More Content Collections

FOCUS ON PATIENTS

  • Like many cognitive conditions, Alzheimer’s disease can cause changes to a person’s speech and language. Artificial intelligence (AI) and machine learning scientists are working on automating speech assessments to detect the disease earlier and improve understanding of the efficacy of novel treatments. 

  • Rare dermatologic disease R&D is growing at a much faster rate than other fields in dermatology. Even before the data readout from our Phase 2b study, we began formulating several possible Phase 3 trial designs and asked scientific, operational, and regulatory questions. Here are our lessons learned.

  • There is a need within the clinical trials community for a broad term to describe clinical trials that make use of digital health tech and other methods for better accessibility to participants. However, is a single term as helpful for patients as it is for clinical trial professionals?

EMBRACING DIVERSITY & INCLUSION