Holiday season hours of operation for Pearl Pathways

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

Pearl IRB’s co -chair, Dr. Gretchen Parker published in Cureus

Gretchen Parker, PhD, RAC, CIP, and Pearl IRB Co-Chair, has completed another article published by Cureus.  The title of the article is “A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”.  The article provides Parker’s unique perspective on IRB processes and review types, offers insight into the IRB decision-making process, and emphasizes the importance of engaging an IRB consultant early in the clinical study design process.

Launching @PearlPathways on Twitter

Making it easy for yPPtwitterimageou to keep up on the latest and connect with us, we recently launched the @PearlPathways twitter account. Please follow us here @PearlPathways. As always, we welcome the opportunity to partner with you — please contact us to talk about your next new idea!


2015 IRB holiday schedule

Pearl IRB has a Full Board meeting scheduled for December 16. There will be no meetings on December 23 or 30. The regularly scheduled Full Board meetings will resume on January 6, 2016. If you have an urgent IRB concern, please contact us at least two weeks in advance. Happy holidays to all!

Pearl Pathways adds Patti Hunker

IMG_4027Pearl Pathways announces the hiring of Patti Hunker, a senior leader in clinical research and management of foundation as Clinical Research Advisor.

Hunker has over 10 years of clinical research experience in both drug and device trials. Previously, she held positions as a clinical research coordinator, research director, head of a fellowship program, and was the Director of the Methodist Sports Medicine Research and Education Foundation. Prior to joining Pearl Pathways, Patti served as the Director of Research and Education at Methodist Sports Medicine leading clinical trials, protocol review, grant writing and the fellowship program.

To see the full press release, click here.

Pearl Pathways Hires John Lockwood

head_shot_JLPearl Pathways announces the hiring of John Lockwood as a Senior Regulatory Compliance Advisor.

Lockwood has over 20 years of experience in quality, regulatory, auditing, and purchasing roles in the life sciences industry. In addition to holding a variety of positions within small and large medical device manufacturers, he also brings nearly a decade of experience in consulting and operations. Prior to joining Pearl Pathways, John led the quality function at an Indianapolis based laser medical device company.

To read the full press release click here.

FDA to release draft guidance on approving medical devices using foreign trial data

Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not intended to announce a new policy, but rather articulate specific measures and considerations that must be applied when using such data to ensure the foreign medical device clinical data is adequate under FDA standards.

Such medical device manufacturers planning on submitting clinical data from outside the United States much provide the following information:

  • Detailed information about the research facilities and qualifications of the trial’s clinical investigators
  • Protocol and results summary
  • Full description of the device
  • Demonstration of the scientific validity for all of the gathered data
  • Ample assurances concerning informed consent

Ultimately, this guide document could provide clarity, help ensure the data is compliant with FDA standards, and allow products to reach the global market sooner.

To learn more, read Outsourcing-Pharma’s article by Zachary Brennan.

Pearl Pathways’ own, Diana Caldwell, named Indiana’s Outstanding Achiever on behalf of CEED

Pearl Pathways is pleased to announce that its President and CEO, Diana Caldwell, has been honored as the Center for Empowerment & Economic Development’s (CEED) Indiana Outstanding Achiever this year. This award is granted by CEED to individuals or organizations that share the CEED vision and demonstrate the true qualities of leadership.

Caldwell shares, “To be associated with such an impressive group of women leaders, I am honored and humbled to be recognized as this year’s Indiana Outstanding Achiever award on behalf of CEED.”

All award honorees for 2015 will be recognized by CEED on Thursday, April 23, in Novi, Michigan at the 31st Annual Award Celebration. This award will also be presented to Caldwell at the Sheraton Indianapolis Hotel at Keystone Crossing on Tuesday, June 9, 2015 at a luncheon reception. To learn more about the celebration, click here.

Click here to read our full press release.

Pearl Pathways sponsoring, attending IVD Conference in San Diego

Q1 Prodcution LogoPearl Pathways is excited to sponsor Q1 Productions’ and attend its upcoming IVD conference on Clinical Affairs and Regulatory Approvals for Diagnostics. The conference provides an excellent opportunity to network with industry experts and gain additional insight on the FDA pathway for next generation sequencing, clinical and regulatory lessons learned in bringing a companion diagnostic to the market, and how to properly prepare for regulatory hurdles outside the United States. Pearl’s own Gretchen Bowker, Co-Founder and COO, will be presenting on ‘Interpreting and Applying FDA Draft Guidance’ at the event.


What: Q1 Productions’ 6th Semi-Annual IVD West Conference

When: May 4-5, 2015

Where: Hilton San Diego Harbor Island – 1960 Harbor Island Drive, San Diego, CA

Pearl Pathways is offering discounted tickets for the event. For more information or to arrange to join us at this event, please contact our Director of Business Development, Chad Pannucci at

Click here to register today. We hope to see you in San Diego!

Updated fee schedule for Pearl IRB effective April 1, 2015

Please note that effective April 1, 2015, Pearl IRB has changed its fee schedule. See our 2015 Fee Schedule to view pricing for your upcoming study. For a price quote for Central IRB services, detailed pricing of your research project, or additional information about our services, please contact us at