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.
institutions
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.
Medicare Coverage Analysis Worksheet
Medicare Coverage Analysis outlines criteria to determine coverage eligibility, guiding trials through compliance with CMS guidelines for billable services.
Your Guide to sIRB Mandates
In the past few years, new regulations and policies have been announced and implemented to address the challenges of conducting clinical trials involving multiple research sites. Chief among these requirements is the use of a designated sIRB for multisite research.
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Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials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
How Paper and Electronic Source Data Meet ALCOA-C Principles
According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re recorded on paper or electronically.
Strategies for Successful Site Selection in Clinical Trials
Clinical trial site selection can make or break a trial’s success before it even begins. The average cost to open