July 2019
IRB Quarterly News
Melissa 2014
Editor's Note

I want to take a moment to extend a very sincere " Thank You " to our dedicated clientele and to your loyalty, trust and continued business.  IntegReview IRB continues to grow year after year and 2019 has been our busiest year yet and THAT is contributable to all of you.

I hope you enjoy this Quarter's Newsletter, which will include special emphasis on our incredible IRB Staff and their recent, well-deserved accomplishments.

We look forward to continuing to serve your IRB needs with the upmost respect, flexibility, and customer service you've become accustomed to!

Melissa Meyer, CCRP

IntegReview IRB is currently looking for highly motivated people that have the ability to multi-task in a fast-paced environment.

Operations Dept.:
IRB Administrative Associate I
IRB Administrative Associate II

Regulatory Compliance Dept.:
Quality Control (QC) Associate
Quality Assurance (QA) Associate

Help us spread the word !  If you happen to know someone in the Austin area looking for work please send them our way.
Congratulations To Our
2019 IRB Staff Promotions!

Angie Martinez, CCRP
Former : IRB Coordinator/Co-chair of Wednesday Board
New :  IRB Operations Specialist - In this new role, Angie will be overseeing the work of the IRB Coordinator/Co-chairs and Assistant Coordinators, where she will apply her 11 years of IRB and regulatory knowledge & expertise to successfully guide her team.

Erik Guerra
Former : Client Services Specialist
New :  Client Relations Manager - In this new role, Erik will share his expertise in client acquisition, retaining customer satisfaction and client retention. 

Melanie Castillo
Former : Assistant IRB Coordinator
New :  IRB Coordinator/Co-chair of Wednesday Board - In this new role, Melanie becomes a voting member of the board and will be responsible for facilitating a weekly IRB meeting and the day-to-day administrative activities that support the board.
Leila Terada
Former : IRB Administrative Associate II
New :  Assistant IRB Coordinator - In this new role, Leila will be assisting the IRB Coordinator/Co-chairs with the day-to-day administrative activities that support the boards; and when needed, will assist with the planning, facilitating, and follow-up of IRB meetings.
Alyson Stockton and Heather Garcia
Former : Quality Control Associate ("QC Associate")
New :  Senior QC Associate - Alyson and Heather have diligently achieved the skillset to "Senior" status and will continue to perform the highest quality control of study documents to enhance and maintain quality of service. 

Sylvia Zamarripa
Former : Quality Assurance Associate ("QA Associate")
New :  Senior QA Associate - With 3 years under her belt in the QA dept., the promotion to "Senior" status is well-deserved.  Sylvia will continue to perform the highest quality assurance of study documents to ensure compliance standards are met.
Kristy Cave
Former : IRB Administrative Associate I
New :  IRB Administrative Associate II - In this new role, Kristy will be learning enhanced job tasks to be able to continue to assist the Operations Dept. with the day-to-day administrative activities following initial IRB approval.

FDA's Key Priorities for Advancing Public Health
New Acting FDA Commissioner, Ned Sharpless, recently talked about the four main priority areas that the FDA will focus on to advance public health: assuring public health through emerging technologies, investing in FDA’s next generation expert workforce and infrastructure, modernizing frameworks, and promoting and protecting consumer and patient safety.

On the emerging technologies front he discussed how FDA is trying to stay ahead of the curve wheel encouraging industry to adopt less costly and more reliable advanced manufacturing platforms. He reported, "We see the promise of technologies like 3D-printed devices, cell-cultured food, cell-based therapeutics, and intentional genomic alterations to animals and plants to deliver enormous benefits to public health.” 

Internal & External
Inspections Are Crucial!

We are frequently asked by our clients about our audit processes and audit history. We want to be transparent and give you an insight to the steps we take to ensure compliance with GCP systems and applicable regulatory requirements.  At IntegReview, we think self-inspection is crucial and; therefore, have implemented an internal audit policy that consists of 3 or more internal audits per month of our study records, performed by our Vice President of Compliance.  Our CAPA Program is also a valuable part of this policy in identifying, recording and rectifying quality issues/problems.

Externally, we receive about 12 pre-audit questionnaires and 6 in-house client audits per year on average. Our history of federal agency inspections include 4 routine FDA inspections over the past 20 years of business, which took place in 2004, 2009, 2013 and the most recent in May of 2019.  A FDA Form 483 was issued in 2004, and no other deficiencies have been observed to date.   
FDA Guidance:                                                        
Live Case Presentations During IDE Clinical Trial
This purpose of this FDA Guidance, issued on July 11, 2019, is to provide IRBs clinical investigators, and FDA staff factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an investigational device exemption (IDE) application. This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation.

A live case presentation is a live or pre-recorded broadcast of a surgical or percutaneous
procedure, typically narrated by the operator, with or without expert panel and/or audience interaction. These presentations are typically broadcast at scientific meetings to increase awareness of the clinical investigation and recruit prospective investigators and study subjects.

Our quarterly S.T.A.R. Award Winners are voted on by their peers, and are recognized for their admirable work ethic and dedication to providing excellent service!

Angie Martinez, CCRP
IRB Operations Specialist
Quarter 3
Creamsicle Margarita

This frozen concoction screams summertime! It's extremely refreshing and the perfect way to relax on the weekends. 
 Cheers !
Meet the IRB Staff
Chris Skruhak
Quality Control (QC) Associate

As a QC Associate, Chris provides quality control on study-related documents in alignment with government regulated guidelines in regards to the protection of human subjects involved in clinical research, with special emphasis placed on enhancing and maintaining the quality of services provided to our clients.

In his free time, Chris enjoys photography, traveling, the outdoors and sports of all kinds. He loves to do brunch on weekends & enjoy Austin with his Partner and Jack Russell Terrier, Gibson.
Shay Battaglio
IRB Administrative Associate II

Shay‘s responsibility as an IRB Administrative Associate II is to assist the IRB committees by processing study-related material following initial IRB approval in alignment with government guidelines and accreditation standards.

Shay was born & raised in Austin and loves to travel & spend time with her family, her husband of 15 years & her 4 fur babies. She lives her life by "the need to laugh often & especially at yourself."  And believes laughing at yourself keeps you healthy, happy, grounded and always reminds you to be humble.

IntegReview IRB | 512.326.3001|  http://www.integreview.com