Sickle Cell Disease: The Importance of Amplifying Patient Voices
Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African […]
Research Operations
NIH 2023 Data Management and Sharing Policy: What you Need to Know
In an effort to accelerate the sharing of biomedical research results, the National Institutes of Health (NIH) issued its finalized
Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
How do you know your experimental therapy is working? Sometimes, it can be as simple to determine as comparing drug
What is a Quality IRB Review?
Metrics in general are one of the ways we can gauge how well a program or service delivers. In the
Beginner’s Guide to Medicare Coverage Analysis
Medicare coverage analysis offers clinical sites a clear billing framework, protecting participants and minimizing financial risks for research studies.
Developing and Implementing a Successful eConsent Process
eConsent simplifies the consenting process for research staff and participants, improving quality and reducing audit issues, especially in hybrid studies.
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
New privacy regulations seem to form every few months, especially with individual U.S. states adopting their own privacy regulations (e.g.,
Why Now is the Right Time to Adopt eConsent
eConsent streamlines trial participation, allowing remote access and minimizing paperwork errors, benefitting both research staff and participants alike.
Beginner’s Guide to Budget Negotiation
Effective negotiation balances firm priorities with flexibility, helping sites align sponsor budgets with true costs while avoiding compliance pitfalls.
Beginner’s Guide to Single IRB Mandates
As clinical trial efficiencies grow, understanding single IRB mandates becomes crucial for sites and sponsors navigating ethical review processes.
Why Keep HIPAA Separate from the Informed Consent Form
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.