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Compliance In Focus


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Posted by Stephani Hulec on Wed, Mar 04, 2015

Regulations in a Flat World

The World Health Assembly is the decision-making body of the World Health Organization (WHO). This assembly draws leading government health officials from the 194 WHO member nations and was first convened in 1948 shortly after the WHO was created. On 24 May 2014, the 67th annual World Health Assembly closed.  This close marked the end to a five day meeting that featured a record-breaking number of agenda items, documents and resolutions, and almost 3,500 registered delegates. During the assembly more than 20 resolutions on important global public health issues were adopted.  These adoptions ranged from issues relating from antimicrobial drug resistance and access to essential medicines to addressing the global challenge of violence and the public impact of exposure to mercury and mercury compounds. Of note, is the passage of a resolution to strengthen regulatory systems.

Topics: Medical Devices, World Health Organization, World Health Assembly, Regulations

Posted by John Lehmann on Mon, Jul 09, 2018

New EU Medical Device Regulations Expected

In an article written by Jamie Hartford and published in MDDI, indicates that new EU medical regulations are expected to be finalized this year or next.  In an earlier blog, we wrote on the pending regulations and the impact it might have on the medical device industry.

Topics: European Union, PIP Scandal, Regulations, MD+DI

Posted by Stephani Hulec on Fri, Jun 03, 2016

What to do when your site no longer “cares” about a study you are monitoring?

It is usually not very difficult to engage sites who have been chosen to participate in a clinical study at the beginning of the trial.  This is an exciting time for any site that is able to bring that new experimental drug or device to their patients who are able to participate in the study!  Many times, during the enrollment phase of the study, sites continue to be excited and active in their roles, and this is usually facilitated by sponsors who are actively encouraging their sites to enroll subjects.

Topics: Clinical Study, Site, Regulations, Clinical Monitoring

Posted by Paul Cobb on Fri, Jun 03, 2016

10 Signs That a Research Coordinator is Spread Too Thin

As a former research coordinator of five years, I am well aware of the extremely busy and highly demanding nature of the job. In addition to balancing multiple trials, subjects, physicians, sponsors, and monitors; coordinators are often required to perform a diverse set of tasks that go beyond the scope of subject visit conduct. This may include regulatory submission and maintenance, laboratory processing and shipping, subject recruiting, and source document creation among others. Furthermore, coordinators often work to facilitate trials across multiple locations and must ensure that studies are conducted in accordance with applicable federal regulations, the investigator agreement or 1572, the protocol, and the rules of the IRB (FAIR SHAKE). Given the multitude of responsibilities, some coordinators may be spread too thin.

Topics: Research Coordinator, Clinical Research, Regulations

Posted by John Lehmann on Wed, Mar 04, 2015

Medical Device Makers and E.U. at an Impasse

As a follow up to our blog on Monday, February 25th, an article in MassDevice indicates that medical device and European Union regulators are at a stalemate over new regulations proposed. The medical device industry supports reforming the current decentralized system by allowing a new Medical Device Coordination Group to request additional assessments. This comes in the wake of the breast implant recall that many believed revealed shortcomings in the E.U.’s regulatory environment.

Topics: Medical Device Makers, European Union, Regulations

Posted by Brandy Smith on Wed, Mar 04, 2015

Finally! Regulation Rules Released: Sunshine Act

It’s been a long time coming but at last the “rules”- the Physician Payment Sunshine Act is final. These are intended to give the public easier access to information on healthcare providers and their financial ties to companies in order to decrease any underlying or potential bias. How will this be accomplished?

Topics: Sunshine Act, Healthcare Providers, Regulations

Posted by John Lehmann on Wed, Mar 04, 2015

Why is Outsourcing a Growing Trend for Medical Devices?

As a medical device CRO, we appreciate the medical device industry sector and look forward to its continued growth and expansion. So, a recent report that highlights the industry’s progression and outsourcing future caught our attention. While there looms uncertainty regarding the medical device tax and the effect on companies, one thing is certain - the medical device industry is experiencing tremendous growth.

Topics: Outsourcing, Medical Device Industry, Regulations

Posted by John Lehmann on Wed, Mar 04, 2015

IMARC’s December e-Newsletter

Today IMARC Research released its 23rd Issue of the IMARC eNewsletter and the last one of the 2012 year. As we reflect back on the year, IMARC Research has a lot to be thankful for. We continue to expand as the result of the trust placed in us by our clients and partners to handle their clinical research needs. We are thankful for these relationships that have helped us grow and prosper.

Topics: Compliance, eNewsletter, IMARC Research, Regulations

Posted by Brandy Smith on Wed, Mar 04, 2015

Protocol “Waiver” from the Sponsor- Is That Enough?

At times, a Sponsor may provide a site with a memo allowing the site to enroll a patient who does not meet all inclusion or exclusion criteria. Or a Sponsor may give the site pre-approval to deviate from the protocol-defined visit windows. Is this waiver enough? Would the investigative site be covered in the event of a federal audit?

Topics: FDA, Regulations, Sponsor, Protocol Waiver

Posted by Sandra Maddock on Fri, Jun 03, 2016

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.

Topics: Sponsor-Investigator, FDA, Regulations, Clinical Monitoring

Posted by John Lehmann on Wed, Mar 04, 2015

Going Green in Clinical Research Trials

In the movement to “go green” and reduce overhead, some clinical sites are moving away from printing every piece of correspondence regarding a research study.  While this may reduce the cost for printer/paper toner, not to mention the time to print and file all correspondence, is this a wise decision?

Topics: Monitors, Going Green, Clinical Research, Regulations

Posted by John Lehmann on Wed, Mar 04, 2015

FDA Required to Write Rudimentary Regulations?

In late April a bill was to congress by a group of bipartisan Senators: Claire McCaskill, Susan Collins, and Tom Coburn.  This bill, “Plain Writing Act for Regulations of 2012,” hopes to accomplish just what the title indicates- require the regulations use plain writing to increase public understanding and participation in the process. What is plain language? A quick internet search yielded this government definition, “communication your audience can understand the first time they read or hear it. Language that is plain to one set of readers may not be plain to others.”

Topics: Plain Writing Act for Regulations of 2012, FDA, Regulations

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