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Medical Device CRO Blog

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Tax-Inversion Push Back

  
  
  
Tax Inversion Push Back

The recent acquisition of Covidien by Medtronic has brought what may be some unwanted attention to companies attempting to move operations overseas for tax-inversion purposes.  The Obama administration is trying to crack down on these strategies, and Treasury Secretary Jack Lew has now issued a letter to congressional tax-writing committees urging lawmakers to limit inversions through a legislative overhaul.  Lew would like immediate governmental action   that is simultaneously retroactive to May 2014, a decision which could have an impact on similar deals that have already taken place.

Will Outcomes Research Make or Break Device Companies?

  
  
  
Will Outcomes Research Make or Break Device Companies

Outcomes research can be defined as “the study of the end results of health services that takes patients' experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.” Recently, the push has been for greater emphasis on outcomes and a new joint effort is a giant boost in this direction.

New Draft Guidance Released: Informed Consent Information Sheet!

  
  
  
New Draft Guidance Released by FDA

It should come as no surprise that FDA has released a new draft guidance regarding informed consent.  Every year, FDAs Bioresearch Monitoring Program (BIMO) releases summative information on the results of the inspections they have conducted on their website.  The results of the inspections conducted are a yearly focus of IMARC as we try to make sense of what the FDA is most concerned with regarding the conduct of research involving human subjects.  Almost inevitably, the most frequent citation from an FDA inspection at a clinical investigation site pertains to improper or inadequate informed consent.  Given that informed consent is one of the most important parts of the research process, it makes sense in that FDA is sharing yet again their “current views” on the concept.

How Important is a Clinical Research Coordinator?

  
  
  
How Important is a Clinical Research Coordinator

Often, when one thinks of the team that actually brings a new medical device or drug to market, the first people that come to mind are those at the sponsor company and the investigators at the individual sites – the leaders of the study.  What may be less known, though, is that often the study hinges on the shoulders of the Clinical Research Coordinator (CRC).  Briefly, CRCs are responsible for the accurate maintenance of the records for the trial, as well as many parts of the trial that otherwise may be overlooked.  Some of the major responsibilities of the CRC are:

Giving Your Studies a FAIR Shake™

  
  
  
Giving Your Studies a FAIR Shake™

Please take time to download and review IMARC Research’s white paper on the FAIR Shake™ training program.  The goal of this white paper is to introduce you to the concept of the FAIR Shake™ in an effort to foster a pattern of thinking that will allow you to navigate through the complexity of the regulatory framework in a very simple way that is based in regulatory fact as opposed to popular opinion.

One Company’s Example of a Risk-Based Monitoring Plan

  
  
  
One Company’s Example of a Risk Based Monitoring Plan

In the world of clinical research, many of us have heard of Bristol-Myers Squibb (BMS), a well-known global biopharmaceutical company.  In a recent article online at Applied Clinical Trials, Thomas Verish, Group Director of Data Operations Services, discusses the risk-based monitoring (RBM) strategy that Bristol-Myers Squibb has begun using.

What Makes Good Clinical Research Training?

  
  
  
What Makes Good Clinical Research Training/departmentofed/

Recently, 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 part our profession.  In addition, FDA regulations require that individuals involved in the clinical research process be qualified by training and experience.  But what constitutes “adequate” training?  This a question often asked of us by the sponsors and investigators we work with.

What are Good Documentation Practices?

  
  
  
Good Documentation Practices

Whether on the site or sponsor level, in clinical research we are asked to use  Good Documentation Practices (GDP) during the conduct of a clinical trial.  One might assume that a quick visit to the FDA website would produce the list of practices.  However, there is no Code of Federal Regulations for GDP.

The Other Side of Clinical Research: Research Administration

  
  
  
Research Administration

Advancements are always being sought out to improve clinical research administration, with better patient care as the ultimate goal.  According to an article on The Association of Academic Health Centers website, the current administrative landscape for clinical trials is exceedingly complex.  Many interdependent functions are spread across the research enterprise, which often results in the establishment of administrative structures and small bureaucracies operating as separate, unconnected silos that lack policies or formal procedures for communications and interaction.  The article goes on to explain that the life cycle of a clinical research project involves stakeholders from different realms of academic health center administration who possess various skills and knowledge about clinical research or business functions.

openFDA – A new FDA program to Increase Transparency

  
  
  
openFDA – A new FDA program to Increase Transparency

On June 2nd, FDA announced the launch of openFDA, a new program through their Office of Informatics and Technology Innovation (OITI).  The program is the latest step in FDAs commitment to increase transparency, and makes health data sets collected by the agency available to the public.  Currently, openFDA is in beta testing mode.  A definitive timeframe for when it will be released in full is not indicated.  The press release posted to the FDA website indicates that the initiative has first made accessible the adverse drug reaction report dataset.  This application programming interface (API) is “search-based” and consists of over 3 million adverse drug reaction reports accumulated from 2004 to 2013.  Future APIs currently listed as “coming soon” through the program include “Product Labels” and “Recalls.” 

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