In clinical trials, the ethical and regulatory standards for conducting research are paramount. Ensuring that the rights, safety, and well-being of participants are protected is the top priority for all parties involved, from investigators to sponsors. However, even with the…
Achieving diversity, equity, and inclusion (DEI) in clinical trials is essential for creating comprehensive, effective medical research that benefits all communities. DEI ensures that clinical research includes a wide range of populations, considering differences in gender, race, ethnicity, socioeconomic status,…
Budget negotiation plays a vital role in the success of clinical trials. Securing proper funding ensures internal costs are covered, supports smoother negotiations, and encourages compliance. Given the high average cost per patient in clinical research, it’s critical to begin…
Clinical research requires more than just scientific expertise – it demands strong financial and contractual management to ensure smooth execution and compliance. Budgeting, negotiating, and contracting are essential pillars that support successful clinical trials. Without a solid financial strategy and…
Efficient clinical trial budget management is essential to the success and sustainability of research sites. It helps to ensure financial viability, maximize return on investment (ROI), and allows for strategic resource allocation. By managing finances effectively, sites can not only…
Navigating the regulatory landscape for medical devices, in vitro diagnostics (IVDs), and digital therapeutics can feel overwhelming. Unlike pharmaceutical drugs, which follow a well-trodden clinical trial pathway (Phase I-III), medical devices often face a unique – and evolving – set…
Navigating Investigator Site File Audits: A Guide to Clinical Trial Compliance Clinical trial audits are a crucial part of ensuring that research is conducted according to regulatory standards and Good Clinical Practice (GCP). However, preparing for an audit can be…
The regulatory framework for both medical devices and medicinal products in the Netherlands is shaped by European Union (EU) regulations, as well as national and local authorities. The following breakdown outlines the key processes and regulatory bodies involved in clinical…
A regulatory binder is crucial for managing clinical trial documents, ensuring compliance with regulations, and supporting audits. It organizes essential documents, providing easy access for trial monitors, auditors, and regulatory authorities, while also serving as a reference for the research…
In our previous article, “The Importance of DMC and CEC in Clinical Research,” we explored the roles, differences, and core values of Data Monitoring Committees (DMCs) and Clinical Event Committees (CECs) in clinical trials. These committees are crucial in ensuring…