GUEST COLUMNISTS

  • Survey Reveals High Levels Of CTIS Adoption In Europe

    Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

  • India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022

    To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

  • Key Learnings To Optimize Clinical Trials During COVID-19

    Designing and conducting trials during the COVID-19 global pandemic forced clinical teams to be creative, to explore the use of technology, and to design a trial that meets the participants where they are — without compromising outcomes. 

  • Key Insights From The 2022 PDA/FDA Joint Regulatory Conference

    Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.

  • How To Implement Patient-Focused COAs

    Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.

  • How To Optimize Returns On Plain Language Summaries

    The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

  • RWE & Advanced Diagnostics Propel Better Patient Outcomes

    Notable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.

  • FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics

    The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

CLINICAL TRIAL WHITE PAPERS

  • User Acceptance Testing And RTSM System Validation

    When implementing a randomization and trial supply management (RTSM) system for a clinical trial, there is a shared responsibility between the RTSM vendor and sponsor organizations to ensure the system performs as intended according to predefined requirements. 

  • Minimizing Luck In Study Feasibility Part 1: Best Practices
    6/29/2021

    Industry statistics reveal that up to 86% of clinical trials do not reach recruitment targets within their specified time periods. In order to turn that number around, sponsors should conduct feasibility studies starting with protocol development and study design. In doing so, they will be able to effectively identify countries, study sites and investigators for conducting the research.

  • The Centricity Of Decentricity: Breaking Down The Basics Of Decentralized Clinical Trials
    3/28/2022

    Recruitment, retention, diversity, efficiency, safety and accuracy are all factors driving the need for radical innovation. Discover why the industry can no longer do the same thing and expect a different result.

  • The Rise Of Hybrid Trials
    9/23/2021

    In this paper, we’ll define what a hybrid trial is, how it utilizes decentralized technologies and the reason for mainstream adoption of hybrid clinical trials.

  • Who Needs Clinical Supply Chain Management Optimization
    9/26/2022

    While sponsors rely on efficient study design, planning, and execution to get their products to market, discover how logistical challenges almost always make it difficult to ensure that sites are prepared for their patients.

  • Supply Chain Optimization: Investigator Sponsored Trials (IST)
    9/30/2022

    This white paper addresses the common challenges faced by biopharma organizations with regards to supply chain management and offers insight into solutions by leveraging the RTSM/IRT.

CLINICAL TRIAL APP NOTES & CASE STUDIES

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

  • Drug developers often talk about “patient centricity,” but most find it challenging to prioritize a patient-centric research approach in the earlier phases of drug development. A good place to start is by collectively measuring what matters most to patients — and COAs help get us there.

  • The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.

  • Between 2000 and 2020, nearly 80% of clinical trial participants were white. The underrepresentation of diverse racial and ethnic groups is not new, but we must do more to address disparities. Here are five strategies for action.

EMBRACING DIVERSITY & INCLUSION

  • Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly so? Or is our thinking stuck somewhere in the past?

  • Whether in the world of employment or clinical trials recruitment, if recruits can’t find what they’re looking for from you, they will find it from someone else or fail to engage entirely. Explore five trends crucial to successful employee and trial participant recruitment.

  • Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America.