Compliance In Focus

Monitors that perform their job at a high level can drive the growth and reputation of their company. The companies that employ these monitors are equipped to meet the needs of their clients and ensure that patient safety and data integrity are maximized.

As a follow-up to a recent blog about the European Union proposing tougher regulations that are similar to FDA’s pre-market approval program in the US, and the medical device industry’s concern over the legislation, it was reported that the EU parliament panel has recently approved the pre-market approval process.

IMARC Research has launched a new YouTube Channel that presents our people and services in a video format.  YouTube is the second largest search engine in the world (just behind Google) and since over 85% of Americans watch videos on-line, we thought it was time to launch our own channel.

IMARC Research will be participating in BioOhio’s Regulatory Forum on October 3rd from 9:00 a.m. – 5:30 p.m. BioOhio has partnered with REU Associates to discuss regulatory issues that impact Ohio’s medical products industry. 

IMARC Research, a  CRO offering monitoring, auditing and training services  and ImageIQ, an imaging contract research organization (CRO) and, have announced a partnership that will strengthen the abilities of both organization’s clients to manage the complexities of imaging within clinical trials, and to enhance FDA approvals by ensuring that scientific data is optimized and that processes are compliant.  ImageIQ will provide IMARC clients with their imaging and image analysis clinical trial expertise.  Conversely, IMARC will bring its 14 years of clinical trial management experience to ImageIQ clients that utilize ImageIQ’s imaging analytics and software development expertise.

We are pleased to announce that due to our continued growth, IMARC Research has moved to larger offices in order to accommodate our continued growth. Just 10 miles south of Cleveland Hopkins International Airport our Strongsville location will give us the added space and flexibility we need to continue to meet our clients’ needs in a high quality, efficient manner for many years to come!

We continue to reach out to our colleagues, customers, and friends in the most convenient places- from Facebook to Linked-In  to Twitter, and even in your very own inbox! Today we distributed the 21st issue of the IMARC e-Newsletter.

IMARC Research is announcing the addition of eight new team members to help accommodate our continued growth.  Seven of the employees will hold the position of clinical research associate (CRA) and one member will be joining the business staff.

In clinical research, the purpose of an Institution Review Board (IRB) is to review and approve research studies involving human subjects. Its purpose first and foremost is to protect patients by ensuring the rights, safety, and well-being of potential research subjects. 21 CFR part 56 contains general standards for the composition, operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA.

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov: