Pearl IRB proudly announces the completion of a clean FDA audit

Pearl IRB clean FDA auditPearl IRB proudly announces the completion of a clean FDA audit. There were no significant findings during the May 2017 audit and FDA issued no 483s. Our AAHRPP accredited IRB operates in compliance with all federal and state regulations governing clinical research. These include FDA regulations 21 CFR Parts 50 and 56, DHHS regulations 45 CFR Part 46 (the Common Rule), the International Conference on Harmonization (ICH), and the Food and Drug Amendments Act of 2007 (FDAAA). Additionally, our independent review board adheres to the portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research as described in 45 CFR Parts 160 and 164.

Pearl IRB has also been audited by sponsors and contract research organizations (CROs) with no significant findings and we routinely engage in our own internal audits to ensure compliance with all relevant regulations.

Holiday season hours of operation for Pearl IRB

As we enter the holiday season, please keep in mind of our operating hours. Pearl IRB will not hold a full board meeting on November 23rd but meetings will resume as scheduled the following week. The office will be open during normal business hours (8 AM – 5 PM EST) except for the following holidays:

  • Thanksgiving
  • The day after Thanksgiving
  • December 23rd
  • December 26th
  • December 30th
  • January 2nd

Purdue professor to host free webinar for RAPS members: Emerging Issues in Manufacturing with Impact on Quality

raps indianaOn Thursday, November 17th, Purdue University’s professor of Medicinal Chemistry, Dr. Stephen R Byrn, will host a free webinar exclusive for members of the Indiana Regulatory Affairs Professionals Society (RAPS) Chapter. Members may register for the webinar here.

Experienced mechanical engineer and life science project manager joins Pearl Pathways

michele-taylorPearl Pathways is excited to announce the hiring of Michele Taylor as a regulatory compliance analyst. Taylor will help the Pearl team serve medical device and biopharmaceutical life science companies.

Taylor brings 12 years of experience in Project Management in Life Sciences, Medical Device Product Development, and Manufacturing to the Pearl Pathways team. Diana Caldwell, President and CEO shares, “Michele brings strong engineering and manufacturing background to the Pearl team. Our clients will benefit from her product development experience and incredible project management skills… We are thrilled to have her join the team.”

To read the full press release, please click here.

Could uniform regulations benefit university research?

According to the Chronicle of Higher Education, the National Academy of Sciences put together a panel of 18 members whom produced a 144-page report on university research growth as the government aims to regulate and monitor it. Some of the recommendations included harmonization and streamlining, in reference to assessing the issue.

The panel proposed that inspectors general be more involved with the process from a collaboration standpoint, and that “the relationship between inspectors general and research institutions should be based on a shared commitment to advancing the nation’s interest through a dynamic and productive research enterprise.”

Such rebalancing among inspectors general has caused issues, as Kenneth Donohue, a former inspector general of the Department of Housing and Urban Development, states that no where in the law does it say anything about collaboration or “collegiality with the programs – it says oversight and independence.”

To read Paul Basken’s article on the Chronicle of Higher Education, click here.

Which one do you prefer: Android vs. iOS?

Take this quick survey to help Gareth MacDonald of In-Pharma decide which mobile operating system is the most preferred in the drug industry.

Updated GCP guideline for clinical trials

As covered in an article by Zachary Brennan in raps.org, the ICH has updated their GCP guideline with the goal to simplify and cut the cost of clinical trials. The aim is to create a more “unified standard for the regulatory authorities in the EU, Japan, US, Canada and Switzerland.” Electronic records and the use of essential documents will provide higher quality and more efficient clinical trials.

Quality management is one of the main criteria for the new guidelines. It focuses on the importance of “human subject protection and the reliability of study results,” and the elimination of risk at both the system and trial levels.

The updated guidelines use a risk-based approach to monitoring clinical trials. While they still require on-site monitoring, centralized monitoring is now being used to provide more extensive methods.

For more information, read Zachary Brennan’s complete article on RAPS.org.

Obama nominates Robert Califf as FDA commissioner

With the previous resignation of Commissioner Margaret Hamburg, there has been talk that current deputy commissioner for medical products and tobacco, Robert Califf, may soon be the new US FDA commissioner.

Concurrently, the US Senate is working to permanently expedite the process of FDA drug approval through legislation. For Zachary Brennan’s full article, click here. For an additional article on this topic, check out Medscape.

Site Solutions Summit 2015

The SCRS is hosting the 10th annual Site Solutions Summit in Amelia Island, Florida from October 8-11. Diana Caldwell, Pearl Pathways’ CEO and President, will act as a panelist on October 10th at 4:00pm for “The Truth of its Impact for Your Site.” To register for the event or for more information, click here.

Check out our new case studies

Interested in learning about how Pearl Pathways has assisted our clients? We have published new case studies featuring pharma, medical device, and academic hospital clients, bringing our total number of case studies to sixteen. You can learn through real life examples of how Pearl Pathways has created solutions for our clients by reading through our dedicated website page here. Contact us for a consultation. To view our case studies, here.