Featured Articles

  1. Reporting To The IRB: Serious Adverse Events (SAEs) In Drug Studies 9/6/2022

    In 2009, the Food and Drug Administration (FDA) released a guidance document on adverse event (AE) reporting to IRBs. This blog examines what the regulations do and do not say about IRB reporting requirements, and addresses some of the undefined “gray areas.”

  2. Grant Application Checklist 8/16/2022

    Use this list of common elements included in research grant applications and budgets to ensure you’ve considered all the necessary resources in your proposal.

  3. Enhancing Research Conduct Using eConsent 8/16/2022

    This blog defines eConsent, offers considerations for conducting eConsent, and navigates communicating with your institutional review board (IRB) as you figure out how to include this process at your organization.

  4. Current State Of Trial Opportunity And Selection 8/16/2022

    Gain insight into the site selection process sponsors undergo and the information sites provide as part of site feasibility questionnaire completion.

  5. Utilizing eRegulatory Integrations To Expedite Regulatory Workflows 7/27/2022

    Explore how direct communication and integration between key operating systems contributes to a more efficient and compliant trial. 

  6. Site-Driven Metrics: Operational Data To Improve Research 7/27/2022

    Sites provide a wealth of data to sponsors and CROs throughout a study. But how much of that data is truly valuable? In this article, we explore the metrics sites need to measure in order to improve internal processes and become more attractive to sponsors and CROs in the future.

  7. Addressing Research Technology Challenges To Gain Sponsor Buy-in 7/27/2022

    In this blog, learn why it is important to encourage sites to seek buy-in from their sponsors as they advocate for using their preferred technology platforms on studies.

  8. The Beginner's Guide To An Electronic Data Capture (EDC) System 7/20/2022

    In this blog, delve into a basic understanding of the EDC system and its role in clinical trials.

  9. Informed Consent: When, Why, And How It's Obtained 7/20/2022

    Aside from being a regulatory and ethical requirement, discover why informed consent is a good way to ensure participant knowledge and start a relationship between researcher and participant.

  10. Return Of Research Results To Study Participants 7/20/2022

    Discover why empirical research into participant views and experiences has consistently shown participants' desire to learn the results of research to which they’ve contributed.