Most medical professionals enjoy being on the forefront of new clinical treatments, techniques and products. Drug and device research trials are a great opportunity for those in the healthcare field to learn about and assist in the development of revolutionary ways to treat patients, before they’re introduced to the public. These studies can provide invaluable […]
IMARC
A solution for your clinical training meeds
Is your company struggling with the growing training needs of your clinical staff? Do you lack the staff and time to implement an effective training program? Every company understands the importance of providing training to help your staff grow, but often companies struggle to identify a solution. Given the importance of training, how do you implement […]
IMARC expands in Minnesota
IMARC expands in MinnesotaIMARC research said yesterday it opened a new office in the Minneapolis area, expanding its medical device market-serving footprint in the state. Get the rest of the story at our sister site, Medical Design & Outsourcing.
ALCOA – The Best Way to Document Your Work
When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”. As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do – and to take […]
Site selection – What to look for?
Selecting clinical sites for research purposes may be a difficult and seemingly overwhelming task for a sponsor. Familiarity with a site might help with selection, but multiple contributing factors can influence whether or not a site is ultimately chosen. Choosing the wrong sites could have a detrimental effect on the study including: Financial impact FDA […]
Adding value to a study with safety monitoring oversight
Researchers agree that the highest standards in clinical research need to be preserved to maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary consideration, the implementation of safety monitoring is paramount. One means of adding this value to a study is utilizing a Data Safety Monitoring Board (DSMB) […]
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic (FD&C) Act
The FDA issued the guidance “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” on May 16th, 2016. Section 522 of the FD&C Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices. Postmarket surveillance means the active, systematic, […]
Title 21: 1981
When you visit IMARC Research’s office, you will notice beautiful artwork on our lobby wall. The artwork pays homage to key events in the history of clinical research. We also released an eBook that describes all the images that make up the timeline and we encourage everyone to take advantage of this important information. In […]
FDA warning letters: Findings for clinical investigators
Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the rights, safety and welfare of human research subjects have been protected and that the validity of research data is accurate to support a marketing […]
GCP… What does it mean?
Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity? Protecting patients is at the core of clinical research and one of the ways research teams can ensure human subjects are protected is through holding up rules, regulations and standards […]
The keys to choosing the right CRO
In the past we have written blogs providing criteria for selecting a Contract Research Organization (CRO). When you’re a sponsor or investigator and you are faced with the decision of hiring a CRO, picking the right organization can be difficult. Finding the right fit for your organization requires a well thought out process with many […]