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Medical Device CRO Blog

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The Sponsor-Investigator: Wearing Two Hats

  
  
  
The Sponsor Investigator Wearing Two Hats

You may have heard the term Sponsor-Investigator before, but just who are they and what do they do?  Just as the title suggests, a Sponsor-Investigator is someone who both initiates (sponsors) and conducts (investigator) an investigation.  This may sound simple, but in actuality, the role can be quite complicated.  However, like anything else, with proper preparation and support it can be accomplished.  Sponsor-Investigators are a rare breed of extremely intelligent, hardworking people who are on the cutting edge of scientific advancement in their respective fields.  They are so committed that they are willing to do essentially twice the work to bring new technologies and advancements to the medical community.

Auditing versus Monitoring: What’s the Difference?

  
  
  
Auditing versus Monitoring   What’s the difference

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?

IMARC Signs Agreement with European CRO

  
  
  
IMARC Signs Agreement with European CRO

IMARC Research and TheraGenesis GmbH of Sutensee, Germany have signed a collaboration agreement to integrate and expand their combined resources, services and expertise in the development of medical devices. The agreement is solely a work-based collaboration with neither firm holding a financial stake in the other.

The Importance of CAPA

  
  
  
The Importance of CAPA

I love the straightforward definition this website provides on CAPA. “Simply put, Corrective Action is based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Both are similar procedurally, but with the focus as described. Together, Corrective and Preventive Actions are integral parts of a continuous improvement program.”

10 Ways to Recruit More Women for Clinical Trials

  
  
  
10 Ways to Recruit More Women for Clinical Trials

I ran across an interesting article in “The Gray Sheet” on strategies to increase the enrollment of women in clinical trials.  The FDA notes that adequate and appropriate populations of women are needed to support 510(k) clearances and PMAs.

Final FDA Guidance: Evaluation of Sex-Specific Data in Medical Device Clinical Studies

  
  
  
Evaluation of Sex-Specific Data in Medical Device Clinical Studies

In August, the FDA issued the final guidance document on Evaluation of Sex-Specific Data in Medical Device Clinical Studies. The intention of this guidance document is to improve the quality and consistency of available data regarding device performance in both sexes for devices that require clinical information in support of a marketing submission or post-approval/post-market surveillance submissions. The primary limitation on devices involves devices that are sex-specific; for instance, urology devices that are designed to be single-sex only.

Direct Access to Electronic Medical Records for Data Verification

  
  
  
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I had an interesting question come up today from a research manager whose site has recently switched to an EPIC EMR system.  She asked if copies of data that she had printed out of EPIC for source document verification for an upcoming visit would be adequate for purposes of source document verification.

Nazi Human Experimentation

  
  
  
World War II Experiments

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 calendar year.

Misconduct in Clinical Research – Room for Improvement

  
  
  
Misconduct in Clinical Research – Room for Improvement

IMARC Research believes history provides important examples of clinical research misconduct  that have helped establish a foundation for understanding the principles that guide modern clinical research.  If you visit our offices, you will see artwork that is featured in our history of clinical research timeline hanging on our walls that depict critical events in history that have helped shape and improve modern clinical research for the well-being of human subjects.

Why Unique Device Indicators are Crucial for Device Surveillance

  
  
  
Why Unique Device Indicators are Crucial for Device Surveillance

The FDA’s Sentinel Initiative, mandated by Congress two years ago to include and cover medical devices, aims to electronically track the safety of investigational products after they have reached post-market. Recently, however, John Rising of The Pew Charitable Trusts informed a congressional subcommittee that lack of unique device identifiers on insurance claims forms poses a major road block to ensuring the effectiveness of this initiative.

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