As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research. The guidance documents for good clinical practice (GCP), ICH E6 and ISO14155, state the sponsor is responsible for quality assurance and quality control within […]
IMARC
New white paper: Elements of a regulatory inspection
While inspections of studies with pending marketing applications are considered routine, FDA has recently shifted its focus toward an early intervention paradigm. Under this design, BIMO Inspections can occur prior to trial completion. This approach allows FDA the opportunity to affect proactive change and continuously improve clinical investigator compliance. Early intervention inspections can be challenging to predict as the […]
What makes good clinical research training?
We have noticed an increase in the demand for training across the clinical research landscape. This should come as no surprise with the constant advances in technology improving the way that clinical research studies are conducted. Those of us involved in this privilege are continually striving to keep up, and continuing education is a regular […]
FDA’s device evaluation program is underway
The Food and Drug Administration (FDA) has been working closely with Industry negotiators and other stakeholders for years to establish a National Evaluation System for medical devices. The goal of establishing such an infrastructure is to generate real world evidence to efficiently monitor the long-term safety and effectiveness of medical devices. In the FDA’s Center […]
The real costs of clinical research
In 1996 The University of Rochester was offering $150 to volunteers for what was designed to be a minimal-risk research study. To 19-year-old Nicole (Hoiyan) Wan, a hundred and fifty dollars meant being able to afford a trip home to see her parents in Queens, New York. Nicole, like many college students, found the money […]
Attn: Data Integrity Compromised
After months/years of conducting your clinical trial, you submit a Premarket Approval Application (PMA) to the Food and Drug Administration (FDA) with the expectation that your Class III medical device will be approved. Unexpectedly, you receive a call from the FDA. The FDA requests to inspect one of your sites to ensure that the data […]
The world of digital health
We are in an era where mobile platforms, such as smartphones, tablets and wearable devices have become a necessity. Mobile applications that run on these platforms provide a variety of entertainment options (games, videos, etc.), allows you to check your electronic mail, and interact with family and friends. Other applications that are being developed are […]
Five hurdles to overcome when planning a medical device trial
By John Lehmann The planning stage is critical to the success of any clinical trial. It sets expectations for how your team will work together to collect data, monitor results, protect human subjects and much more. The inherent complexity of a medical device trial and the fact that it requires surgical implantation makes it especially […]
The Benefits of Using an Independent CRO to Manage Your DSMB or CEC
Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC). But should they be implemented for your study, it’s important to know they are not all created equal. The Data Safety Monitoring Boards (DSMB) review cumulative information from a study and monitor safety oversight with teams of independent physicians […]
Trust the Process
Merriam Webster defines a case study as a published report about a person, group, or situation that has been studied over time; also : a situation in real life that can be looked at or studied to learn about something. Case studies can be useful to help highlight how to handle a particular situation, including […]
Good Clinical Practice: From Review to Application
In clinical research many rules and regulations exist to govern the way research is conducted and to protect those patients who are participating in research. One of the standard principles directing clinical research is Good Clinical Practice. Good clinical practice is more than any one document; rather, it is a collective compilation of many thoughts, […]