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.
Effective negotiation balances firm priorities with flexibility, helping sites align sponsor budgets with true costs while avoiding compliance pitfalls.
As clinical trial efficiencies grow, understanding single IRB mandates becomes crucial for sites and sponsors navigating ethical review processes.
Medicare Coverage Analysis outlines criteria to determine coverage eligibility, guiding trials through compliance with CMS guidelines for billable services.
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.
The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
In 2016, the Food and Drug Administration (FDA) approved Spinraza (nusinersen). It was the first drug to treat children with
On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). These notices proposed
Study startup is a complicated, multi-faceted process – notoriously prone to delays due to the many stakeholders, systems, and decisions
In the blink of an eye, the world has gone digital. So many tasks which used to require going to
According to the FDA, data should meet certain fundamental elements of quality (ALCOA), whether they’re recorded on paper or electronically.
Clinical trial site selection can make or break a trial’s success before it even begins. The average cost to open