Compliance In Focus

As a result of lacking documentation, missing data, or noted discrepancies, research professionals may turn to the use of a memo or note to file (NTF) to record and explain issues throughout a clinical trial.

We’ve all heard and advocated that “if it wasn’t documented, it wasn’t done”, but is a note to file the best way to remedy absent or deficient documentation?

Research coordinators can bind the clinical research process together to ensure that a trial is efficient and compliant.

With subject safety, protocol and regulatory compliance, and quality data collection being at the forefront of their crucial role, research coordinators truly are vital to clinical research.

While the specific responsibilities and daily tasks for research coordinators can differ, it is irrefutable that research coordinators play an essential and significant role in clinical trials.

Using 3D printing for medical devices is becoming more common amid the COVID-19 pandemic, as demand for critical personal protective equipment (PPE) continues to outpace supply.

3D printing, which is also known as additive manufacturing, involves a process in which two-dimensional layers of raw material are joined sequentially to build a rapidly constructed three-dimensional object.

The design and production of products using 3D printing have resulted in reduced material waste, conserved energy, and decreased time to bring products to the market. The capability of 3D printing can provide designers and manufacturers the flexibility of modifying a structural design without needing to alter machinery or tools in a manufacturing process. Such technological advancements have increased the use of 3D printing in the medical device industry.

With the aim to contain and mitigate rapid spread, the global pandemic of the novel

Each year, the FDA publishes its Bioresearch Monitoring (BIMO) metric findings to provide insight on audit trends and significant violations. The BIMO program’s inspectional data includes Clinical Investigative Sites, Institutional Review Boards (IRBs), Sponsors/Monitors, Contract Research Organizations CROs), Bioequivalence, and Good Laboratory Practice Audits.

=As we have done in past years, IMARC examined the warning letters posted on the FDA’s website to compile the top findings from BIMO inspections. This year, we are reflecting on the top findings of previous years and discussing trends seen in 2018.