What do I do About Incidental Findings in Research?
An incidental finding is a “finding” or result from an intervention or test that uncovers a condition or problem that […]
Informed Consent
eClinical Regulatory Trends Impacting Clinical Research
For the past two years, the clinical research industry has seen an acceleration in staff shifting to a remote, work
Connecting Patient Centricity and eConsent Together
Patient-centric trial design, combined with eConsent, fosters better communication, comprehension, and retention, ensuring a smoother, more informed journey.
Research Equity and Enrolling Non-English Speakers
Informed consent, a cornerstone of ethical research, involves describing important elements of research in a way that permits participants or
3 Must-Haves to Deploy Remote Clinical Trials
This blog covers three must-have decentralized trial tools to efficiently and compliantly implement remote modalities at your organization.
Key CTMS Capabilities to Improve Financial Management
A well-utilized CTMS streamlines financial workflows, automates participant payments, tracks budgets, and centralizes data, helping clinical sites maximize ROI and efficiency.
GCP Assessment During COVID – “Did Your Clinical Trials Remain GCP Compliant During COVID-19?”
We are now almost a year into the COVID-19 pandemic, and you may be asking whether your clinical trials remained
Informed Consent: When, Why, and How It’s Obtained
Informed consent isn’t just a formality—it’s an evolving process that safeguards participant autonomy and enhances study integrity from start to finish.
Understanding the Complexity and Uniqueness of Phase I Trials
In clinical research, working with organizations that understand the ins and outs of the phase of your trial is key
The Many Faces of “Coercion” and “Undue Influence”
The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
As part of FDA’s response to combat COVID-19, FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC). The
Beginner’s Guide to Investigator-Initiated Trials
While many clinical trials are initiated by industry sponsors, such as pharmaceutical companies or contract research organizations (CROs), other trials