News & Events

Pearl IRB announces the completion of a clean FDA audit

(6/12/17) Pearl IRB proudly announces the completion of a clean FDA audit. There were no significant findings during the May 2017 audit and FDA issued no 483. Read more about the audit and our AAHRPP accredited IRB here.

 

Experienced clinical research associate joins Pearl IRB

(5/26/17) Pearl IRB announces the hiring of Masheka Fuqua as a Clinical Research Associate to serve biopharma, medical device, and diagnostics companies. Learn more about Masheka in the full press release.

 

Regulatory 101 workshop for medical device professionals will feature Pearl IRB co-founder & COO, Gretchen Bowker

(5/8/17) The Indiana Medical Device Manufacturers Council (IMDMC) will host REG 101 on May 17, 2017. Gretchen Bowker, RAC, FRAPS, will educate attendees about FDA regulations and pathways to market for medical devices. Learn more and register here.

 

Entrepreneurship panel connecting startups to big biz will feature Pearl IRB CEO

(5/2/17) A panel of prominent Indy business owners & executives will discuss how big biz utilizes small businesses and startups to solve problems. Diana Caldwell, President & CEO of Pearl IRB, will speak on the May 9th panel. Find more info in our blog.

 

Pearl IRB sponsors upcoming Indiana Life Sciences Collaboration Series

(4/25/17) The Kelley School of Business Center for the Business of Life Sciences presents Workforce Issues – Life Sciences Human Capital. The event will be held on May 12, 2017 at the Cook Group Headquarters in Bloomington, IN. Register today and visit our blog for details.

 

Pearl IRB presents educational workshop “The Impact of Software in Medical Device Development”

(4/11/17) Pearl IRB presents an educational workshop, The Impact of Software in Medical Device Development, in collaboration with Indiana Medical Device Manufacturers Council (IMDMC) and Barnes & Thornburg Law LLP. Pearl speakers include Senior Advisor, John Lockwood, and President & CEO, Diana Caldwell.

 

Pearl IRB President & CEO featured in Indianapolis Star

(4/7/17) Diana Caldwell, President & CEO of Pearl IRB, is featured in an Indianapolis Star article describing her dedication to mentoring young professionals through a program offered by the Healthcare Businesswomen’s Association – Indiana Chapter.

 

Annual IBJ publication, BioFutures, includes an article written by Pearl IRB President

(3/20/17) Pearl IRB President and CEO, Diana Caldwell, is featured in the 2017 issue of BioFutures, the official magazine of IHIF and IMDMC which is published annually by the Indianapolis Business Journal. Caldwell provides her perspective on the medical device industry in Indiana in her article, “The best part of medical devices in Indiana is YOU.” Read this year’s issue.

 

March 3rd: Diana Caldwell speaking at 3rd annual KLLC Women’s Empowerment Retreat

(2/27/17) Diana Caldwell, CEO of Pearl IRB, will speak at the 3rd annual Women’s Empowerment Retreat hosted by the Indiana University Kelley Learning Living Center. Please visit our blog to learn more about the event.

 

Inside Indiana Business (IIB) publishes article written by Pearl IRB President & CEO

(2/1/17) Inside Indiana Business (IIB) published an article written by Pearl IRB President & CEO, Diana Caldwell, titled “Can you de-risk the hiring process?” In the article, Caldwell discusses her positive experience with Employ Up, a targeted talent development program through EmployIndy.

 

Experienced marketing and sales professional joins Pearl Pathways as first Texas hire

(12/15/16)  Pearl Pathways announces the hiring of Waylon Wright as a Marketing and Sales associate. Learn more about Waylon and view the full press release.

 

Experienced project manager joins Pearl Pathways

(12/1/16) Pearl Pathways announces the hiring of Shawn Knopp, PhD as an Advisor. Please see our blog to learn more about Shawn and view the full press release.

 

Experienced quality analyst joins Pearl Pathways

(11/17/16) Pearl Pathways announces the hiring of Phillip Bishop as a quality analyst. Please see our blog to learn more about Phillip and view the full press release.

 

Free Life Sciences webinar on Thursday 11/17 for RAPS members

(11/15/16) Dr. Stephen R. Byrn of Purdue University will address “Emerging Issues in Manufacturing with Impact on Quality.” For registration information, please visit our blog.

 

Experienced mechanical engineer and life science project manager joins Pearl Pathways

(11/7/16) Pearl Pathways announces the hiring of Michele Taylor, an experienced mechanical engineer and project manager, as a regulatory compliance analyst. Please see our blog to learn more about Michele and view the full press release.

 

Pearl Pathways’ Gretchen Bowker lectures at Tools & Techniques in Translational Research course

(11/2/16) On November 22nd, Pearl Pathways COO, Gretchen Bowker, MS, RAC, FRAPS will lecture on the topic “Drug Development: Goin’ to the FDA” for Indiana Clinical and Translational Sciences Institute (CTSI) Fall 2016 course Tools and Techniques in Translational Research. Check out our blog for more information.

 

Pearl Pathways sponsors upcoming Indiana Life Sciences Collaboration Series

(11/1/16) On November 18th, Indiana Life Sciences Collaboration Conference Series presents Indiana’s Life Sciences Ecosystem – The Last 10 Years and the Next 10 at IU School of Medicine, Fairbanks Hall, in Indianapolis.  Register today and visit our blog for details.

 

Dr. Gretchen Parker published in Cureus

(10/28/16) Check out this article entitled, “A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”  published in Cureus by Pearl IRB’s own Dr. Gretchen Parker, IRB Co-Chair.  Visit our blog for more details.

 

Pearl Pathways attending IMDMC conference

(10/21/16) Stop by our exhibitor booth at the annual Indiana Medical Device Manufacturers Council (IMDMC) conference on October 27th.  Visit our blog for more information.

 

Caldwell moderating panel discussion at ACRP Circle City Chapter Symposium

(9/21/16) On October 3rd, Pearl Pathways’ own Diana Caldwell will moderate a panel discussion at the ACRP Circle City Chapter’s 16th annual fall symposium at the Ritz Charles in Carmel.  See our blog for details.

 

Save the date for Indiana CTSI Event on September 23rd

(9/8/16) On September 23rd, the 8th annual meeting of the Indiana Clinical and Translational Sciences Institute (CTSI) and Watanabe Prize Lecture is being held at Hine Hall on the IUPUI Campus.  To learn more about the event, see our blog.

 

October 3rd ACRP Circle City Chapter Conference

(8/31/16) Save the date for ACRP Circle City Chapter’s 16th Annual Excellence in Critical Research on October 3, 2016 at the Ritz Charles in Carmel, Indiana.  Visit our blog for more information.

 

RAPS publication features chapter by Gretchen Parker

(8/11/16) Proud to announce our own Gretchen Parker contributor to RAPS publication “Global Medical Device Regulatory Strategy”.  See our blog for more details on the book and how to order.

 

Announcing Dr. Gretchen Parker, IRB Co-Chair earns CIP Certification

(8/8/16) Pearl IRB’s own Dr. Gretchen Parker has earned the CIP certification.  To learn more about this excellent achievement, see our blog.

 

Caldwell completes Goldman Sachs 10,000 Small Businesses – Babson Cohort

(7/6/16) So pleased to announce Pearl Pathways’ CEO and President Diana Caldwell completes GS10KSB. Goldman Sachs 10,000 Small Businesses is a national program created to help entrepreneurs create jobs and economic opportunity by providing greater access to education, capital, and business support services.  Taking next steps in growing our business.

For more information, visit our blog.

 

June 13th 2nd Annual Cell Therapy and Regenerative Medicine Symposium sponsored by Pearl Pathways

(6/07/16) On June 13, the 2nd Annual Cell Therapy and Regenerative Medicine Symposium will be held at The Athenaeum in Indianapolis, Indiana. COO Gretchen Bowker will be attending and offering 1-1 consulting sessions with researchers on Day 2. Visit our blog for more information.

 

June 16th RAPS Indiana Chapter evening meeting

(5/25/16) An evening of networking and expert presentation for regulatory professionals — RAPS Indiana Chapter, chaired by Pearl Pathways’ COO Gretchen Bowker, meeting on June 16th at The Rathskellar. See our blog for more details.

 

Pearl Pathways proud sponsor of Indiana Life Sciences Collaboration Conference Series

(5/6/16) Indiana Life Sciences Collaboration Conference Series at Cook Medical World Headquarters in Bloomington, IN on May 13th. The topic of discussion is The Shift from In-patient to Alternate Care Settings. To learn more about the event, click here to read our blog. Hope to see you there!

 

Upcoming IMDMC workshop featuring Pearl Pathways’ own Gretchen Bowker

(4/13/16) Gretchen Bowker will present at the IMDMC workshop on April 21st in Indianapolis, IN. The topic is Pathways to Market – 510(K) Requirements. Read our blog to learn more about the workshop. We hope to see you there!

 

April 8th, Pearl Pathways’ COO and Co-Founder Gretchen Bowker speaking for Purdue at Roche campus

(4/6/16) Purdue University course held at Roche campus on April 8-9 for Purdue students. See our blog for more details.

 

Chad Pannucci, Director of Business Development honored as Indiana Council for Biomedical Innovation (ICBI) Advisory Council Member

(3/23/16) Our own Chad Pannucci has been recognized among an elite group of Indianapolis area life science industry executives to form the new Indiana Council for Biomedical Innovation (ICBI) Advisory Council. Visit our blog and check out the press release for more information.

 

Pearl Pathways’ own Diana Caldwell serving on CEO Panel held at Butler University, March 7th

(3/3/16) On March 7th, Butler University will be hosting a CEO Panel Discussion for MBA students. See our blog for more details.

 

Pearl IRB’s President and CEO speaking on Professional Panel at the second annual KLLC Women’s Empowerment Retreat on March 4th

(2/26/16) On March 4th, the Kelley Living Learning Center (KLLC) will be hosting their second annual Women’s Empowerment Retreat. Visit our blog for more details.

 

Pearl IRB’s President and CEO serves as panelist for IHIF’s “Clinical Trials from a Study Site Perspective” luncheon event, February 16th

(2/11/16) On February 16th, the Indiana Health Industry Forum (IHIF) and Barnes & Thornburg present “Clinical Trials from a Study Site Perspective” at the Barnes & Thornburg office at 11 S. Meridian Street in downtown Indianapolis. For more information and to register, click here. Visit our blog for more details.

 

Follow us on Twitter @PearlPathways

(2/2/16)  Our Pearl Pathways is on twitter! Follow us @PearlPathways for relevant IRB and clinical research updates about the industry and Pearl IRB. Check out our blog for more details.

 

2016 WISE Luncheon – Pearl Pathways sponsors

(1/13/16)  On January 29, 2016 BioHouston will honor women leaders in STEM at the 7th annual Women in Science with Excellence (WISE) Luncheon held at the River Oaks Country Club in Houston, Texas.  For more information, click here.  Visit our blog for more details.

 

Pearl Pathways selected for Purdue Economic Gardening Program

(1/7/16)  Pearl Pathways is pleased to announce being selected to work with the Purdue Economic Gardening Program for second-stage growth.

To read the full press release, click here.

 

Pearl Pathways is expanding into Texas

(11/20/15): We are excited to announce our growth and expansion through a second location in College Station, Texas. The new office will be part of The Garage, which is supported through the Research Valley Partnership.

Click here to read the full press release.

 

Pearl Pathways to partner with greenlight.guru

(11/9/15): We are pleased to announce a partnership with eQMS service provider, greenlight.guru. For the full press release, click here.

 

Join us at the ACRP symposium

(11/2/15): The ACRP fall symposium will be held on November 6th in Indianapolis at the Sheraton Hotel. Pearl Pathways will be exhibiting and employees, Gretchen Bowker, Diana Caldwell, Mary Anne Gfell, and Patti Hunker, will be speaking. For event details, click here. To read more about Pearl Pathways’ involvement in the event, click here.

 

Visit our booth at the annual RAPS Regulatory Convergence

(9/16/15): Pearl Pathways will be exhibiting at the annual RAPS Regulatory Convergence in Baltimore, Maryland, from October 24-28. For more information, click here.

 

Join us at the Site Solutions Summit

(9/11/15): From October 8-11, the SCRS is hosting the global Site Solutions Summit. It is not too late to register. To learn more about the event, click here.

 

John Lockwood speaks at IMDMC workshop

(9/10/15): The Indiana Medical Device Manufacturing Council’s second part of their two-day program was held in Indianapolis. John Lockwood, of Pearl Pathways, spoke on the topic of inspections. Click here for more information.

 

Pearl Pathways hires Mary Anne Gfell

(9/9/15): We are excited to welcome our new Clinical Research Advisor, Mary Anne Gfell, to the Pearl Pathways team.

Click here to read the full press release. 

 

Industry and regulations workshop hosted by IMDMC

(8/28/15): On September 10th, the IMDMC is hosting the final workshop for those interested in learning more about the industry and FDA regulations.

To read the full blog post, click here. To register for the event, click here.

 

HBA’s interview’s Caldwell for its “meet the membership” newsletter

(8/6/15): Pearl Pathways, Diana Caldwell, interviewed with the Health Businesswomen’s Association (HBA) on July 20th for their upcoming newsletter “meet the membership.” To read the full blog post, click here.


Pearl Pathways excited to announce its celebrating 5 years

(7/28/15):  On August 6th Pearl Pathways will be hosting a party to celebrate its 5 years of being in business. Please join us if you can!  To find out more information on the part, click, here.


Pearl Pathways pleased to announce its hiring of Patti Hunker

(7/10/15):  Patti Hunker joins Pearl Pathways as its senior leader in clinical research and management of foundation as Clinical Research Advisor.  To read the full press release, click here.


John Lockwood joins Pearl Pathways

(6/25/15): We are pleased to that John Lockwood will be joining the Pearl Pathways team as a Regulatory Compliance Advisor. To read the full press release, click here.


Pearl Pathways’ Gretchen Bowker moderates the June 22nd session of the AFDO meetings

(6/22/15): Pearl Pathways’ Gretchen Bowker, will be moderating the Association of Food and Drug Officials (AFDO) morning session. This event will be held from June 20th to Juen 24th at the Indianapolis Sheraton at Keystone Crossing. To read on the topics of her moderation and to find out more about the event, click here.

 

Fall 2015: Grace College presents Sarah Witwer’s class

(6/19/15): Sarah Witwer, is teaching “RCA5500 Regulation of Medical Devices: Submission” this fall at Grace College in Warsaw, Indiana. This is her third year teaching at Grace College and she has experience as a regulatory compliance advisor.

To find out more about the class, click here.


Pearl Pathways’, Gretchen Bowker, speaking at upcoming IMDMC event

(6/11/2015): OnJune 25th, Gretchen Bowker will be presenting on “Pathways to Market” at the IMDMC workshop in Indianapolis, IN. To learn more about the workshop click here to read our full blog.


WBEC grants Diana Caldwell as the Outstanding Achiever of 2015

(6/9/2015): Women’s Business Enterprise Councils – Great Lakes (Indiana) gives the Outstanding Achiever Award of 2015 to Pearl Pathways CEO and Presidnet, Diana Caldwell!

To read more click here.


Pearl Pathways sponsors Q1 Productions’!

(5/4/2015): Pearl Pathways will attend Q1 Productions’ IVD conference on Clinical Affairs and Regulatory Approvals for Diagnostics in San Diego. One of the presentations at the conference will be from Pearl’s Gretchen Bowker, on ‘Interpreting and Applying FDA Draft Guidance at the event. To read more about the conference and sponsorship, click here.


Diana Caldwell awarded Indiana’s Outstanding Achiever by CEED

(4/23/15): Pearl Pathways is excited to announce that its President and CEO, Diana Caldwell, has been named this year’s Indiana Outstanding Achiever on behalf of the Center for Empowerment & Economic Development (CEED). Read our full press release here.


Chad Pannucci joins the Pearl Pathways team

(3/9/15): Pearl Pathways is pleased to announce the hiring of Chad Pannucci as our new Business Development Director. Click here to read our full press release.


Upcoming IMDMC workshop featuring Pearl Pathways’ own, Heidi Strunk

(3/3/15): Heidi Strunk will be presenting at the IMDMC workshop on April 15th in Indianapolis, IN where she and other experts will explore the FDA inspection process and provide tips for preparation. To learn more about the workshop, click here to read our full blog. We hope to see you there!


Pearl IRB becomes second AAHRPP Accredited organization in Indiana

(2/17/15): By earning AAHRPP accreditation, Pearl IRB demonstrates high standards of quality and excellence in all levels of research – this further distinguishes the uniqueness of Pearl IRB. For more information, read our full press release here.


Gretchen Bowker to hold webinar on ComplianceOnline

(2/16/15): Pearl Pathways is pleased to announce that our own COO and Co-Founder, Gretchen Bowker will instructing a webinar entitled Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements on March 19th at 1:00 PM EST via ComplianceOnline. Click here for the registration link.

Read our blog for more information.

 

Pearl employee publishes article on RAPS.org

(1/16/15): Pearl’s own, Heidi Strunk, earned a publication in the RAPS online journal Regulatory Focus.  The article can be located on RAPS.org (Login and Password required) and is entitled Types of In Vitro Diagnostics: Clearing Up the Confusion.”  With an abundance of acronyms, in vitro diagnostics (IVDs) can become complicated to classify. This article considers six types of IVDs to clear up the confusion.  To read full article, click here.

 

Pearl IRB now accredited by AAHRPP

(12/19/14): Pearl IRB is proud to announce its recent accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP). As stated in the full press release by AAHRPP, “to earn AAHRPP accreditation, organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to high standards for research.” For more information, read the full press here.

 

The Asia-Pacific Summit for Medical Devices

(12/3/14): Pearl Pathways and Brandwood Biomedical are hosting the The Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations featuring a variety of local experts from Asia-Pacific.

When: March 5-6, 2015

Where: Hilton San Diego Mission Valley Hotel

Register here before December 5 to enjoy the lowest early bird pricing!

We hope to see you in San Diego!

 

Pearl Pathways to partner with Brandwood Biomedical

(12/3/14): Pearl Pathways is pleased to announce a global partnership with Brandwood Biomedical, an Australia-headquartered regulatory and quality services company with offices throughout Asia. This collaboration allows both companies to provide on-the-ground support to clients and better adapt to the changes and complexities associated with global markets. For more information, read our full press release here.


Diana Caldwell presenting at Central Indiana WBE Forum in November

(11/4/14): Pearl Pathways’ own President and CEO, Diana Caldwell will be presenting at the Central Indiana Women’s Business Enterprise (WBE) Forum held in Indianapolis in November. The topic for this session is “5 Steps to Up Your Business Development Game.” Please join us for this exciting event! Click here to learn more.

 

Pearl Pathways releases new whitepaper “Types of In Vitro Diagnostics: Clearing up the Confusion”

(10/29/14): Pearl Pathways has published a new whitepaper entitled “Types of In Vitro Diagnostics: Clearing up the Confusion.” The paper discusses the many categories of IVDs and their requirements and regulations. These categories include RUOs, IUOs, ASRs, LDTs, Companion Diagnostics, and IVDMIAs. This paper is a must read for anyone involved in the development of IVDs. Click here to read!

 

Join us at the 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

(10/24/14): Pearl Pathways is excited to be attending the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies used to successfully bring a companion diagnostic to market. The conference will also feature Pearl’s own Gretchen Bowker as a moderator for the workshop discussion on Establishing Realistic Timelines for Companion Diagnostics & Personalized Medicine Development. For more information, read our blog.


2014 Site Solutions Summit to feature Diana Caldwell

(9/19/14): The 2014 Site Solutions Summit will feature Pearl Pathways’ own President and CEO, Diana Caldwell as a moderator for the Crowdsolving topic entitled Tweet, Post, Like, Engage In Social Media For Results. In aligmnent with the structure of Crowdsolving sessions, Diana will be joined by a cross section of expert panelists, who will provide unique perspectives on your sites’ pain-points. The session will be highly interactive with attendees.  Diana’s industry and social media expertise provides valuable insight into creating best site practices. For more information, click here.

 

2014 RAPS features Gretchen Bowker as a speaker

(9/17/14): Pearl Pathways is pleased to announce that our own Gretchen Bowker will be speaking at the 2014 RAPS Preconference Workshop entitled Regulatory Strategy Forum for Biologics. She will be presenting at the 11am session on conducting clinical trials, which will cover the roles and responsibilities of sponsors, investigators, IRBs, and regulatory authorities as they relate to the development of biologic products. To learn more, click here.


Indiana Life Sciences Conference Series features Pearl co-founders

(9/8/14): Pearl Pathways invites you to join us on Friday, September 12th for the first conference of the 2014-2015 Indiana Life Sciences Collaboration Series entitled, An Update on the FDA and Global Regulatory BodiesIn addition to sponsoring the event, Pearl Pathways is pleased to announce that both of our co-founders, Diana Caldwell and Gretchen Bowker will be serving as moderators as a panel of experienced industry professionals will discuss the potential affects of new approval procedures and quality compliance requirements.

Read our blog for more information.


Upcoming Kelley School career event features Diana Caldwell as panelist

(9/2/14): The Kelley School of Business Indianapolis Career Network is hosting a Career Momentum Event featuring Pearl Pathways’ own President and CEO, Diana Caldwell as a panelist. This event will provide an opportunity to network with experienced executives and gain expert insight on how to push your career to the next level. We encourage you to join us at the IU Advancement Office in Indianapolis on Thursday, September 11 from 5:30pm-8:00pm. Register today!

 

Pearl sponsors RAC study group

(8/20/14): Are you planning to take the RAC US exam? Do you need some support to ensure you are prepared?  Gretchen Bowker, RAC, chairman of the Indiana RAPS chapter and co-founder of Pearl Pathways is sponsoring a study group to help prepare for the RAC US exam. Brown-bag lunch sessions will be held every other Tuesday beginning on September 1st from noon – 1pm at Pearl Pathways. These sessions will be available via webcast, however in-person attendance is certainly encouraged. Our office is located at 29 East McCarty Street, near Shapiro’s. Free parking is available on the East side of the building. Please join us for an opportunity to network with colleagues and expand your regulatory knowledge. Please email koakley@pearlpathways.com if you are interested.

To access the study group schedule and presentation material, click here.

 

Pearl Pathways honored as one of the 2014 Indiana Companies to Watch

(7/18/14): Pearl Pathways is excited to announce our recognition as one of the 2014 Indiana Companies to Watch. We are among the twenty-seven companies that will be honored at the 2014 Indiana Companies to Watch ceremony on August 20th at the Indiana Roof Ballroom in Indianapolis. To read ISBDC’s announcement of the winners, click here. To read the full press release, click here.

 

Zac Unger joins the Pearl Pathways team

(7/7/14): We are pleased to announce the hiring of Zac Unger as a Regulatory Analyst. To read the full press release, click here. To read the full blog, click here.

 

Heidi Strunk to present at IMDMC Regulatory 101 session

(6/25/14): We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. Pearl Pathways’ own Heidi Strunk will be presenting an overview of post-market regulatory requirements at 9:00am. To read the full blog, click here.

 

Pearl Pathways Hires Heidi Hancock Strunk

(6/23/14): Pearl Pathways is pleased to announce the recent hiring of Heidi Hancock Strunk, RAC as a Regulatory Compliance Advisor. To read the full press release, click here.

 

New forms and resources for IRB submissions on the Pearl IRB website

(6/19/14): We are pleased to announce our recent updates to the Resources section of the Pearl IRB website. To read the full blog, click here.

 

Gretchen Bowker presenting webinar for SCRS

(6/6/14): We are pleased to announce that Pearl Pathway’s own Gretchen Bowker will be presenting a webinar on preparing for an FDA audit on December 16, 2014 for the Society of Clinical Research Sites. To read the full blog click here.

 

Gretchen Bowker to present at IMDMC

(5/7/14): We are pleased to announce that Gretchen Bowker will be presenting at IMDMC on May 15th, 2014 at 1:00. To read the full blog click here.

 

Gretchen Bowker to speak at new St. Vincent Health series

(4/8/14): We are happy to announce that Gretchen Bowker will presenting at the bi-monthly St. Vincent Research Brown Bag lunch Series. She will be presenting on 4/10/2014 at noon. To see the full blog click here.

 

Pearl staff publish article on RAPS.org

(1/16/14): Several of our employees earned a publication in the RAPS online journal Regulatory Focus.  The article can be located on RAPS.org (Login and Password required) and is entitled “Regulatory Approval of Biosimilars: a Global Perspective”. This is a captivating article reviews the effects of biosimilar products have on the global community and how those countries’ regulations look to affect the development of such products.

Contributing authors:

  • Gretchen Miller Bowker, MS, RAC, FRAPS
  • Gretchen Parker, PhD, RAC
  • Sarah Witwer, JD, RAC

 

Sage Journal publication co-authored by Pearl Pathways’ COO, Gretchen Bowker

(12/17/13): Gretchen Bowker, COO of Pearl Pathways has completed another article that was just published by Sage Journal. The title of the article is “Labeling Standards for Biosimilar Products” (Login and Password required). Along with her co-author Dr. Davis, the article provides an informative view on the repercussions of Congress’ implementation of a regulatory pathway for approval of Biosimilar products. Also discussed is the influence FDA will have on this regulation.

Contributing authors:

  • Pearls own Gretchen Miller Bowker, MS, RAC, FRAPS
  • Gregory C. Davis, PhD

 

Article from Pearl IRB staff featured in SCRS InSite magazine

(11/25/13): Check out this article (login registration is required) entitled “What could proposed changes to the Common Rule mean to sites, sponsors and IRBs” published in the Q2 2013 edition of the Society for Clinical Research Sites’ online journal, InSite. See the full blog entry here.

 

Site Solutions Summit will feature Caldwell as panelist and moderator

(10/11/13): The 2013 Site Solutions Summit features Pearl Pathways’ own Diana Caldwell. She will be involved in the roundtable discussions as a panelist and moderator for topics such as: Investigator Insider: What your site needs to know about your next potential investigator; and Your Circle of Friends: Why social media matters. For more information, see our blog.

 

American Chemical Society (ACS) national meeting in Indianapolis – Bowker to serve on panel on September 9th

(8/23/13):  Gretchen Miller Bowker, Pearl IRB COO, will be a featured speaker at the ACS annual meeting. The title of the talk is “Best Practices for Success in Startup and Growing Businesses ?” The session is held from 9:45 – 11:40 am in Indianapolis, IN at the Indiana Convention Center on September 9, 2013.  To register and see the full agenda, click here.

 

Bowker to serve as moderator at September 6th Kelley Life Sciences Collaboration Series

(8/23/13):  Gretchen Miller Bowker, Pearl IRB COO, is serving as the moderator for the morning speakers panel focused on Resources.  IU’s Kelley School Center for the Business of Life Sciences is holding the event, and the title of this conference is ” Indiana as a Life Sciences Hub in 2023 – What Will it Take?” and will be held in Indianapolis, IN on September 6, 2013.  To register and see the full agenda, click here. Pearl is a proud sponsor of the 2013-2014 Life Science Series Collaboration series.

 

Mark Killion joins Pearl Pathways as new Business Development Director

(7/12/13): Pearl Pathways announces the recent hiring of Mark Killion as their Business Development Director. Killion is an experienced business development talent in the life science industry, boasting an impressive sales portfolio throughout his career. He has built a wide range of therapeutic area expertise across both biopharma and device companies. He is a proven sales leader with additional skills in training, managed care, staffing, and marketing. To read the full press release, click here. For media coverage in an online article on Inside INdiana Business, click here.

 

Pathways’ employees Bowker and Looney featured in upcoming webinars

(7/12/13):  Pearl Pathways employees Gretchen Bowker and Ellen Looney will be hosting webinars through ComplianceOnline.com in July and August.    Bowker will be leading discussions on FDA supplier audits on July 25, 2013, and regulatory paths and requirements for drugs on August 8th, 2013. Looney will lead a webinar in GCP training on July 26th, 2013. Registration for all three events can be found here.

 

Gretchen Bowker featured speaker for class

(6/28/13):  Pearl Pathways’ own Gretchen Bowker will be speaking next week at a 5-day Translational Research and Entrepreneurship course providing practical training to translational scientists in “how-to” navigate the many steps required to develop a start-up company. She will be sharing her regulatory expertise to the crowd.

 

Open house a great success

(6/25/13):  Pearl Pathways’ open house last Thursday the 20th welcomed in the new office with a bang. A refurnished interior to an old Indianapolis building on the south side of the city filled with friends, family, clients, and colleagues created a great atmosphere for all. Thank you to everyone that came out for the open house! If you would still like to stop by and see the new office call (317) 899-9341 or email openhouse@pearlpathways.com

 

Pearl Pathways will host an open house

(6/11/13):  Pearl Pathways has moved to our new office!  We are excited to share our new home with clients and colleagues.  Please join us if you can.  Appetizers and refreshments will be severed throughout the evening.  For more information click here.

 

Pathways’ Looney featured in St. Vincent Health Research Symposium

(6/11/13):  Pearl Pathways’ own Ellen Looney, regulatory clinical & quality associate, will be speaking at the 9th annual St. Vincent Health Research Symposium on June 12th. Her topic will be Good Clinical Practices (GCP): “Just the FAQ’s Mamm”. For more information and registration click here.

 

Pathways partners with Hoosiers Work for Health

(5/1/13):  Pearl has partnered with Hoosiers Work for Health, a national initiative that unites health consumers, biopharmaceutical company employees, vendors, suppliers and other business and community partners to showcase the importance of the life sciences industry on the Indiana economy and on the quality of health for Hoosiers.

 

Pearl Pathways has moved

(4/12/13):  We have moved!  Effective April 15, 2013, our new office location is 29 East McCarty Street, Suite 100, Indianapolis, IN 46225.  Please stop by and visit us.  Look for an invitation to an Open House in June.

 

Caldwell will serve on IHIF lunch panel

(4/10/13):  Diana Caldwell, Pearl President and CEO will serve on the IHIF lunch panel on April 16, 2013 at Barnes and Thornburg, LLP in Indianapolis. To learn more, click here.

 

Pearl Pathways hires three new employees

(2/25/13):  Pearl Pathways announces the hiring of three new associates, Daphine Glowner, Gretchen Parker, PhD, RAC and Sarah Witwer, JD, RAC. Glowner’s editorial and project management skills combined with Parker’s scientific technical experience and Witwer’s regulatory prowess add to the strong team at Pearl Pathways. To read the full press release, click here.

 

Caldwell will speak for The Leadership Institute for Women

(2/24/13):  Diana Caldwell, Pearl President and CEO will speak on a panel at The Leadership Institute for Women: Positioning Your Business for Growth on February 28, 2013 at Duke Realty in Indianapolis, IN.  To learn more, click here.

 

Bowker to be featured at MAGI conference

(2/10/13):  Gretchen Miller Bowker, Pearl IRB COO, is speaking at the MAGI Clinical Research Conference in Boston, MA which goes from May 5-8, 2013.  The topic is: Medical Device Regulations: How device and drug regulations and guidances differ. To learn more click here.

 

Pathways to expand in the future

(1/30/13):  Pearl Pathways announces company expansion and receives incentive package for training grants and tax credits from the Indiana Economic Development Corporation on January 29, 2013.  Click here to read more.

 

Pearl IRB releases new whitepaper

(12/12/12):  Pearl IRB releases new whitepaper entitled What could proposed changes to the Common Rule mean to sites, sponsors, and IRBs?
on December 13, 2012.  To review all of our whitepapers, click here.

 

Site Solutions Summit will highlight Caldwell

(8/25/12):  Diana Caldwell, Pearl Pathways President and CEO, is speaking at the 2012 Site Solutions Summit in Palm Beach Gardens, FL on October 12-14, 2012. The topic will be “Sales Strategies for A Successful Site.” To learn more, click here.

 

Caldwell will speak at IWL Annual Women’s Leadership Conference

(8/15/12):  Diana Caldwell, Pearl Pathways President and CEO, is speaking at the IWL Annual Women’s Leadership Conference in Indianapolis, IN on October 2, 2012. Title of talk is “What? You want to run your own business? Of course you do.” To learn more about the conference, click here. To register, click here.

 

IBJ Biofutures publishes Pathways’ expansion

(8/7/12):  Pearl Pathways has been covered by IBJ Biofutures 2012. The article discusses Pearl’s expansion last year. To read our blog posts about the IBJ coverage, click here.

 

PharmaVoice covers Pathways twice in one month

(5/10/12):  Pearl Pathways has been featured twice by PharmaVoice.com in 2012.  To view Pearl’s mention in their January 2012 article, click here.  To view their mention in the April 2012 article, click here.

 

Bowker speaking at MAGI

(5/5/12):  Gretchen Miller Bowker, Pearl Pathways COO, will be speaking at the MAGI Clinical Research Conference in Washington, DC which goes from May 20-23, 2012.  The topic is: Ask the IRBs- Answers may be different than what your IRB is telling you. To learn more click here.

 

Bowker a panelist at INpact meeting

(4/12/12):  Gretchen Miller Bowker, Pearl Pathways COO, will be serving as a panelist at the April 20th INpact meeting held in Indianapolis, Indiana.  Gretchen will discuss the FDA 510(k) process and how it will change and affect medical device companies.  To learn more, click here.

 

Pathways’ Bowker will lead discussion

(11/20/11):  Gretchen Miller Bowker, Pearl Pathways COO, will lead the discussion, INDs vs IDEs: Likenesses and Differences, at the ASQ MWDG Meeting December 1 at the University of Indianapolis at 5:30pm.  For more information or to sign up for the dinner and discussion, click here.

 

Inside Indiana Business’ Big Wigs & New Gigs

(10/27/11): Gretchen Miller Bowker was honored as RAPS Fellow in a recent news release.

 

Pearl Press Release – Gretchen Miller Bowker Honored as RAPS Fellow.

(10/24/11): As thousands of regulatory compliance professionals converge in Indianapolis, Pearl Pathways’ COO honoredVisit our Pearl Pathways website and click here to view full press release.

 

Pearl Pathways expansion featured on CenterWatch News article

(10/17/11): Read the online article, Pearl IRB expands compliance and consulting.

 

Pearl Pathways featured on Outsourcing-Pharma Article

(10/4/11): Read the article, Pearl IRB to launch new consulting and regulatory compliance divisions.

 

Pearl Pathways featured on Applied Clinical Trials Article

(10/3/11): Read the online articlePearl Pathways to Parent Pearl IRB and Two New Sister Companies.

 

Pearl Pathways featured on Inside Indiana Business Article

(9/29/11): Read the article, Life Science Company Unveils Expansion Plans.

 

Pearl Press ReleaseMeeting Clients’ Needs, Pearl Family Expanding

(9/29/11): Pearl Pathways to Parent Pearl IRB and Two New Sister Companies. Visit our Pearl Pathways website and click here to view full press release. 

 

Gretchen Bowker co-authored article published in ACRP Monitor

(9/1/11): Read the article, Human Research Protection:  Not Just an Obligation, a Career, page 21-22.

 

Gretchen Miller Bowker, Pearl Pathways COO presenting at RAPS

(8/29/11): Pearl Pathways’ own Gretchen Miller Bowker will be presenting an “Overview of Drugs and Biologics” at this year’s Regulatory Affairs Professionals Society (RAPS) annual meeting held at the Indiana Convention Center in Indianapolis, IN from October 22 – 26, 2011. For more information about the conference, click here.

 

Indiana RAPS Chapter kickoff

(8/15/11): Don’t miss the kick off meeting for the Indiana chapter of RAPS to be help 4-7pm on August 30, 2011 at the IUETC in Indianapolis, IN.  To learn more, click here.

 

Gretchen Miller Bowker speaking at IMDMC annual meeting

(8/1/11): IMDMC’s (Indiana Medical Device Manufacturers Council) annual meeting held October 6th in Indianapolis, IN features Pearl’s COO, Gretchen Miller Bowker in a talk entitled “FDA/OHRP efforts to modernize and revise regulations and guidance.” To learn more, click here.  Pearl is also an exhibitor at this event.

 

Pearl IRB’s COO, Gretchen Miller Bowker speaking at RAPS conference

(8/1/11): Pearl IRB’s COO featured speaker at upcoming REGULATORY CONVERGENCE, the national RAPS (Regulatory Affairs Professional Society) conference, October 22 – 26, Indianapolis, IN.  Gretchen Miller Bowker’s session is October 23 and title is “Overview of Drugs and Biologics.”  Pearl is also exhibiting, so please stop by booth 432 in the Exhibit Hall.  To learn more, click here.

 

Pearl IRB Press Release

(7/8/11): Pearl IRB and Trafalgar Ethics Board partner to deliver integrated US – Canada IRB review services. Click here to view full press release.

 

Pearl featured in IHIF BioFutures magazine

(3/21/11): Pearl IRB is featured in the annual Indiana Health Industry Forum BioFutures magazine for promoting clinical trials in Indiana. See the full magazine here.

 

Gretchen Miller Bowker to speak at 2011 MAGI conference

(3/20/11): Pearl IRB Chief Operating Officer speaking in Philadelphia, PA at May 22-25, 2011 MAGI Clinical Research Conference.  To register and learn more, click here.

 

Clinical Research networking event

(3/15/11): Barnes & Thornburg LLP and Pearl IRB host their quarterly clinical research networking event in March. To register and learn more, click here.

 

Pearl IRB’s COO speaking at IMDMC regulatory roundtable

(1/27/11): Gretchen Miller Bowker, COO, Pearl IRB is speaking at the IMDMC regulatory roundtable “Effectively Managing Multi-Center Trials” to be held in January. To register and learn more, click here.

 

Gretchen Miller Bowker speaks at 2011 ASQ meeting

(1/11/11): Pearl IRB’s own COO, Gretchen Miller Bowker will be speaking at the 2011 ASQ meeting. To register and learn more, click here.

 

Pearl IRB founders featured in the Lilly alumni network newsletter

(12/1/10): To read the full story on IRBs, clinical trials, and how Pearl IRB is making a difference, click here.  The fall 2010 Lilly alum network newsletter was published and distributed in early December 2010.

Pearl IRB receives national certification as a Women’s Business Enterprise

(11/8/10): Pearl IRB received national certification as a Women’s Business Enterprise by the Great Lakes Women’s Business Enterprise Council, a regional certifying partner of WBENC (Women’s Business Enterprise Council).

 

Pearl IRB co-hosts clinical research event

(11/1/10): Barnes & Thornburg LLP and Pearl IRB to host a special event focused on the regulatory aspects of clinical research on December 2, 2010. To register and learn more, click here.

 

Pearl IRB President and CEO speaking at IHIF event

(11/8/10): Pearl’s own Diana Caldwell will be speaking on the panel at the IHIF event “Social media for the life sciences” on November 8, 2010. To learn more and register, click here.

 

Midwest ASQ chapter meeting

(9/23/10): Gretchen Bowker, Chief Operating Officer, will present an overview of the requirements and regulations surrounding IRB reviews at the midwest ASQ chapter meeting.  Meeting held over dinner at University of Indianapolis, 5:30-8pm. To sign up, contact us at info@pearlirb.com or email John Freije, President of the Midwest ASQ chapter, at john@freijequalityengineering.com.

 

Pearl IRB featured in CenterWatch article

(8/31/10): First commercial IRB opens in Indiana to fill geographic gap and attract clinical research.

 

Pearl IRB featured in IBJ

(8/21/10): Read the article, Pearl IRB first firm in state to pre-screen clinical drug trials.

 

Indiana Health Industry Forum Luncheon

(8/17/10): Gretchen Bowker, Chief Operating Officer, will present an overview of the  regulatory issues regarding combination products.  Meeting is held downtown Indianapolis at the offices of Barnes and Thornburg.   To register, click here.

Pearl IRB Featured in Inside Indiana Business and IBJ articles

(8/4/10): Read the IBJ article and the Inside Indiana business article, Efforts to Attract More Clinical Trials.

 

Pearl IRB Press Release

(8/1/10): Pearl brings solution to more clinical trials.

 

Pearl IRB featured in CenterWatch and PharmaVoice articles

(4/26/10): Read the CenterWatch Weekly article (see Profile: Independent Review Board). Read the PharmaVoice article about IRBs (see page 50 to read article).

 

Women's Business Enterprise Certified