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Medical Device CRO Blog

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FDA New Guidance on Informed Consent: Updates to Required Elements

  
  
  
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In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.

Why Do We Need to Audit?

  
  
  
Why Do We Need to Audit

How is auditing different than monitoring?  Why do we need to audit?  Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

4 Barriers to Recruitment in Clinical Trials

  
  
  
4 Barriers to Recruitment in Clinical Trials

It’s an unfortunate reality in clinical research; Oftentimes sites struggle to recruit subjects.  Frustration trickles down from the principle investigator and on down to the coordinators as sponsors put pressure on sites to enroll, enroll, enroll.  What are the barriers to recruitment and how can they be overcome?

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.

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