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
sites
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.
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.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the first drug to treat children with
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed
Modernizing Site Feasibility and Selection
Study startup is a complicated, multi-faceted process – notoriously prone to delays due to the many stakeholders, systems, and decisions
Unpacking IRB Innovations for Decentralized Clinical Trials
In the blink of an eye, the world has gone digital. So many tasks which used to require going to