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AdvaMed Provides FDA with its Own Priority List

  
  
  
AdvaMed Provides FDA with its Own Priority List

AdvaMed, the medical device trade group has never been shy about sharing its opinion with the FDA.  According to a recent article in Medical Device and Diagnostic Industry (MD+DI), AdvaMed has voiced its opinions on what priorities the medtech industry believes the FDA should prioritize.

Why Good Clinical Practice is So Important

  
  
  
Why Good Clinical Practice is So Important

In a report from the Institute of Medicine (IOM) was based on a workshop held with this focus: “Public Engagement and Clinical Trials.” In this report, IOM draws attention to the fact that many clinical trials are slow to enroll patients, and some studies never reach their recruitment number goal.

The Declaration of Helsinki - 1964

  
  
  
The Declaration of Helsinki   1964

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2015 calendar year.

5 Tips for Backing up Your Coordinators from Clinical Monitors!

  
  
  
5 tips for backing up your coordinators from Clinical Monitors

During a training module this week, a group of monitors were discussing the importance of back-up coverage. Monitors that are conducting visits in the field know that juggling schedules can be very challenging. To provide thorough and consistent monitoring, experienced monitors are assigned to a clinical trial or a study team. Next, training is extended into the therapeutic area of research and sponsor specific trainings including SOPs and monitoring plans.  But what about back-up coordinators- are they trained and ready?

IMARC University Course Catalog: Available Now!

  
  
  
IMARC University Course Catalog

We are excited to have recently launched IMARC University, our latest service offering designed to make clinical research education more widely available to the industry.  IMARC University is a series of affordable online training and continuing education courses designed to prepare you and your team for clinical research compliance.  These courses cover many aspects of the clinical research process, from FDA regulations and Good Clinical Practice standards to adverse event reporting and how to conduct monitoring activities.  All courses can be taken at your own pace.  We can even create and customize additional training to meet the needs of your team.

How Can You Bolster Clinical Trial Enrollment?

  
  
  
How Can You Bolster Clinical Trial Enrollment

Your site is weeks past study initiation and all the candidates that you expected to be screening for the study have not materialized.  Would trial-related advertising or recruitment materials enhance your sites enrollment efforts?

Auditing versus Monitoring: What’s the Difference?

  
  
  
Auditing vs. Monitoring

In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?

Gamification: Can it Help Engage Subjects in Clinical Trials?

  
  
  
Gamification

Gamification is defined as “the process of turning an activity or task into a game or something resembling a game.” This concept has been leveraged in the fields of education and marketing to create engagement with a topic or product by using game playing techniques such as point scoring, achievement badges, or virtual currency.

Update on Strategic Priorities for CDRH

  
  
  
Update on Strategic Priorities for CDRH

The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.

FDA Kefauver-Harris Amendment (1962)

  
  
  
FDA Kefauver-Harris Amendment

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently  released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

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