GUEST COLUMNISTS

  • 4 Pitfalls To Avoid With RWE For Regulatory Submissions

    Despite the lack of a central catalog of all real-world evidence (RWE)-related regulatory decisions, there are a handful of product approvals and FDA reviews that highlight both best practices and common pitfalls sponsors face. Avoid these 4 pitfalls.

  • FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs

    The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion cohorts to evaluate safety, anti-tumor activity, and other properties of oncology drug products, all within a single protocol. This article shares details of the guidance as well as advantages and risks of using this trial design.

  • Best Practices For Designing Patient-Centric Decentralized Clinical Trials

    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.

  • 3 Best Practices For Actionable CRO Oversight

    The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.

  • How To Create An Effective Clinical Supply Visual Dashboard

    It is challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Randomization and trial supply management (RTSM) systems do not encapsulate all the necessary data. It is vital to have an internal central inventory system that maintains oversight of the IP inventory from start to finish and to manage resupplies.

  • How Can I Use Real-World Data In Clinical Trials?

    Real-world data (RWD) and real-world evidence (RWE) can be relevant and essential to bringing innovation to patients and gaining regulatory approval. This article describes the sources of real-world data, how to use real-world data to enhance a development program, and how RWD and RWE advance regulatory decision-making.

  • 2021 Clinical Research Site Survey Findings: A Year In Flux

    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.

  • 2 Emerging Investigators Share Their Journeys Into Clinical Research

    There is an urgent need to introduce more physicians to clinical research and train the next generation of investigators to reach more patients with participation opportunities. Expanding the pool to include investigators like Richard Bernstein, MD, and Thomas Moriarity, MD, is a vital step to addressing this challenge. They share their experiences in this article.

CLINICAL TRIAL WHITE PAPERS

  • Vendor Management And Oversight Of Clinical Trials
    8/9/2021

    Vendor management and oversight of clinical trials continues to be a critical activity for sponsor companies planning and conducting clinical trials. Read how vendor management and oversight is not only a regulatory imperative, it is also a business imperative.

  • Innovative Pharmacotherapy In Alzheimer’s Disease: Facilitating Access As Well As Approval
    10/21/2021

    Read how regulatory approval for a novel therapeutic targeting one or more phenotypes of Alzheimer’s disease (AD) is necessary but insufficient for ensuring both adoption and patient access.

  • Minimizing Luck In Study Feasibility Part 2: Predictive Analytics
    6/29/2021

    Sponsors conducting study feasibility must weigh variables ranging from epidemiology to enrollment benchmarks. This lends itself to a machine-learning approach vs. manual analyses. Even greater time and cost savings can be realized when study feasibility is applied to trials in niche patient populations, where limited availability of data precludes conventional approaches.

  • Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring
    9/8/2020

    Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?

  • Implementing Solutions To Virtualize And Decentralize Clinical Trials
    8/11/2021

    Traditional clinical trials are multi-site human studies that integrate numerous in-person study visits and endpoints. However, as clinical studies become more complex, it is more important than ever to develop new trial models that can accommodate novel endpoints and provide greater flexibility to study participants.

CLINICAL TRIAL APP NOTES & CASE STUDIES

  • How Did Medrio Achieve FPI In Seven Days?
    6/2/2021

    With an industry average of 12 weeks, it’s incredible that we enabled Cytovale, Inc. to achieve their first patient in (FPI) in just seven days. In a time where speed is of the utmost importance, Medrio supported Study Builders, LLC to build the study and Cytovale to begin enrolling patients in the study in just seven days. The Cytovale technology will allow patients with sepsis to be identified earlier in their hospital stay.

  • Multivigilance In The Cloud
    8/3/2020

    Manufacturers must monitor how each product they sell performs with real patients as they use it outside the carefully controlled conditions of a clinical study. This process of multivigilance – the management of safety information for different kinds of medicinal products such as drugs, vaccines, medical devices, and combination products – is required throughout the entire product lifecycle. Continue reading to learn how cloud technology makes patient safety less expensive and more efficient.

  • Streamlining Regulatory Submissions For A Novel Advanced Therapy Medicinal Product Trial
    10/28/2021

    The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex, and the approval pathway depends on product classification. This case study describes how product classification may not always be clear-cut, given the proliferation of novel approaches to ATMP development.

  • Health Data Trends Part 1: Top Data Types In Demand
    1/20/2022

    Over the last few years, connecting health data is evolving from innovation to standard practice. Data is connected to create a robust picture of patient health, to accelerate research, improve care, and lower healthcare costs. Learn about the seven health data trends.

  • An Excerpt from CRO Quality Benchmarking - Phase II-III Service Providers, 12th Edition
    7/2/2020

    Which provider is best to conduct a given trial? Who will perform the best? This report includes insights from 233 experienced Phase II/III outsourcers and nearly 700 service provider encounters – all helping to frame what you need to be in the driver’s seat.

  • Fast, Focused Medical Data Review: Use Cases By A Medical Monitor
    11/30/2021

    For medical monitors, the problem with off-the-shelf analytics tools is the lack of tailoring for medical review needs. The right data visualization tool can help medical monitors to tailor and improve their data review processes and enhance their ability to identify safety signals both quickly and surely.

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

  • For rare disease clinical trials, communications are enabled by working closely and effectively with patient advocacy organizations. In this article, a director of scientific and patient affairs shares 4 tips on what has helped their company overcome some of the barriers.

  • When Gilead launched its Phase 3 study of investigational lenacapavir for PrEP, the team recognized that any clinical pathways intent on introducing new PrEP options must commit to addressing and effectively bridging existing gaps if we strive to drive real change in HIV prevention. This is the story of how Gilead approached trial design in an innovative manner.

  • Earlier this year, the MedTech Color Collaborative was created with a goal of convening a diverse cross-section of industry stakeholders to work together to identify issues and opportunities for improvement in this critical space. The group shares and curates existing knowledge and strives to develop evidence-based solutions and best practices to address the health inequities facing minorities. 

EMBRACING DIVERSITY & INCLUSION