Heidi Strunk to present on Inspection Readiness at upcoming IMDMC workshop
(3/3/2015): Heidi Strunk will be presenting at the IMDMC workshop on April 15th in Indianapolis, Indiana where she and other experts will explore the FDA inspection process and offer tips for preparation. Click here to read our full blog to learn more about the workshop. We hope you join us on April 15th!
Pearl IRB just second AAHRPP Accredited organization in Indiana
(2/17/2015): Pearl IRB demonstrates high standards of excellence in all levels of research by earning AAHRPP accreditation – this further distinguishes the uniqueness of Pearl IRB. To read our full press release, click here.
Upcoming webinar on ComplianceOnline instructed by Gretchen Bowker
(2/16/15): Pearl Pathways is pleased to announce that our own COO and Co-Founder, Gretchen Bowker will be instructing a webinar entitled Nutraceuticals/Dietary Supplements: FDA Regulatory Submission and Manufacturing Quality Requirements on March 19th at 1:00 PM EST via ComplianceOnline. Register here today!
For more information, read our blog.
RAPS.org article published by Pearl employee
(1/16/15): Pearl employee Heidi Strunk, earned a publication in the RAPS online journal Regulatory Focus. The article can be found on RAPS.org (Login and Password required) and is entitled “Types of In Vitro Diagnostics: Clearing Up the Confusion.” In vitro diagnostics (IVDs) can become complicated to classify with an abundance of acronyms. This article considers six types of IVDs to clear up the confusion. Click here to read full article.
Pearl IRB announces AAHRPP accreditation
(12/19/14): Pearl IRB is excited to announce its recent accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP). According to 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.” Click here to read the full press release.
The Asia-Pacific Summit for Medical Devices
(12/3/14): Pearl Pathways and Brandwood Biomedical will be 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 announces global partnership with Brandwood Biomedical
(12/3/14): Pearl Pathways is pleased to announce a 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 to present at Central Indiana WBE Forum
(11/5/14): 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!
Pearl Pathways to attend, present at 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.
Diana Caldwell to be featured at 2014 Site Solutions Summit
(9/19/14): Pearl Pathways’ own President and CEO, Diana Caldwell will be featured at the 2014 Site Solutions Summit 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.
Gretchen Bowker to speak at 2014 RAPS
(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.
Pathways’ co-founders speaking at Indiana Life Sciences Conference Series Event
(9/8/14): In addition to sponsoring the 2014-2015 Indiana Life Sciences Collaboration Conference Series, Pearl Pathways is proud to announce that both of our co-founders, Diana Caldwell and Gretchen Bowker, will be serving as moderators for this year’s first conference entitled An Update on the FDA and Global Regulatory Bodies.
What: An Update on the FDA and Global Regulatory Bodies
Where: IU Robert H. McKinney School of Law, 530 W. New York Street, Indianapolis
When: September 12, 2014 8:00am-3:15pm
Click here for the registration link.
Read our blog for more information.
Diana Caldwell to serve as panelist for upcoming Kelley School career event
(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. Register now, or click here to learn more!
Pearl Pathways hosting RAC study group
(8/21/14): 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 firstname.lastname@example.org if you are interested.
To access the study group schedule and presentation material, click here.
Pearl Pathways honored in 2014 Indiana Companies to Watch
(7/18/14): We are excited to announce our recognition as one of the 2014 Indiana Companies to Watch. Pearl Pathways is 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.
Pearl Pathways hires Zac Unger
Heidi Strunk Presenting at IMDMC
(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.
Heidi Hancock Strunk joins the Pearl Pathways team
(6/20/14): Pearl Pathways is pleased to announce the hiring of Heidi Hancock Strunk, RAC as a Regulatory Compliance Advisor. To read the full press release, click here.
New IRB submission forms and resources on the Pearl IRB website
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 excited to announce that Gretchen Bowker will be presenting at the IMDMC event May 15, 2014 at 1:00. To read the full blog click here.
Gretchen Bowker to Present at St. Vincent
(4/9/14): 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.
New Pearl Pathways LinkedIn page
(3/21/14): Pearl Pathways is excited to announce the launch of our new LinkedIn page which is now available to be seen. We will be posting exciting blogs and new information that pertains to the life science industry. To see the full blog click here or to visit our LinkedIn page click the link.
Pearl staff publish article on RAPS.org
(1/16/14): On January 16, 2014, several of our employees earned a publication in the RAPS online journal Regulatory Focus. The article can be found on RAPS.org (Login and Password required) and is entitled “Regulatory Approval of Biosimilars: a Global Perspective”. This is a fascinating article that reviews the impact of biosimilars on global communities throughout the world and how different countries’ regulations affect biosimilar development.
Sage Journal publication co-authored by Pearl Pathways’ COO, Gretchen Bowker
(12/27/13): Gretchen Bowker, COO of Pearl Pathways has earned another published article in Sage Journal. The title of the article is “Labeling Standards for Biosimilar Products” (Login and Password required). Together with her co-author Dr. Davis, the article provides an educational view on the impact of Congress’ implementation of a regulatory pathway for approval of Biosimilar products. Also discussed is the impact FDA will have on this regulation.
- Pearls own Gretchen Miller Bowker, MS, RAC, FRAPS
- Gregory C. Davis, PhD
Need assistance with mapping out a path for your biosimilar? Contact us for assistance.
InSite journal features article authored by Pearl staff
(11/25/13): Pearl staff contributed to a recent 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 more details in a blog entry here.
Pathways’ Caldwell a panelist and moderator for Site Solutions Summit
(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.
Bowker featured as speaker in American Chemical Society annual meeting
(8/23/13): Gretchen Miller Bowker, Pearl IRB COO, will be a featured speaker at the ACS annual meeting. The session is entitled “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
Kelley Life Science Collaboration September 6th event features Bowker as panel moderation
(8/23/13): Gretchen Miller Bowker, Pearl IRB COO, will serve as the moderator for the morning panel of speakers 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?” This conference 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.
Pearl Pathways hires new Business Development Director, Mark Killion
(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 story in Inside INdiana Business, click here. To view the full press release, click here.
Pathways’ Bowker and Looney hosting 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.
Pathways’ Bowker will speak at course
(6/28/13): Pearl Pathways’ own Gretchen Bowker will be speaking July 1st 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 huge success
(6/25/13): Pearl Pathways’ open house last Thursday the 20th welcomed in the new office with a bang. The afternoon get together was a fun way for visitors to stop by and see the new place. 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 email@example.com
Pearl Pathways will hold 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.
Looney featured in St. Vincent Health Research Symposium
(6/6/13): 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 announces its partnership with Hoosiers Work for Health, the Indiana chapter of 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): Pearl Pathways is on the move! Effective April 15, 2013, our new office location is 29 East McCarty Street, Suite 100, Indianapolis, IN 46225. Please stop by and visit us. Please look for an invitation to an Open House we plan to have in June.
Caldwell will speak in IHIF luncheon
(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.
Pathways hires three new employees
Caldwell will speak on panel for The Leadership Institute for Women
(2/24/13): Diana Caldwell, Pearl Pathways President and CEO will present on a panel at The Leadership Institute for Women: Positioning Your Business for Growth held 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 Pathways 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.
Pearl Pathways plans to expand
(1/30/13): Pearl Pathways announces expansion and receives incentive package from the Indiana Economic Development Corporation on January 29, 2013. Click here to read more.
New whitepaper released
(12/12/12): Pearl IRB releases new whitepaper on December 13, 2012 entitled What could proposed changes to the Common Rule mean to sites, sponsors, and IRBs? To review all of our whitepapers on Pearl IRB, click here.
Site Solutions Summit will feature Pathways’ Caldwell
(8/25/12): Diana Caldwell, Pearl Pathways President and CEO, will be speaking at the 2012 Site Solutions Summit on October 12-14 at the PGA National Resort & Spa in Palm Beach Gardens, FL. Topic of the discussion will be “Sales Strategies for A Successful Site.” To learn more, click here.
Caldwell to speak at 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 discusses Pathways’ expansion
(8/7/12): Pearl Pathways has been covered by IBJ Biofutures. The article discusses Pearl’s expansion last year. To read our blog posts about the IBJ coverage, click here.
PharmaVoice.com covers Pearl Pathways twice
Bowker speaking at MAGI
(5/5/12): Gretchen Miller Bowker, Pearl Pathways COO, is 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 named a panelist to speak 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, go here.
Pearl Press Release- Pearl Pathways has recently hired J. Ellen Looney as a full time employee. Looney will serve as an IRB adminstrator and will also assist clients with consulting projects. To view the full press release, click here. To see coverage of her hiring by insideindianabusiness.com, click here
Inside Indiana Business’ Big Wigs & New Gigs October 27, News Release, Gretchen Miller Bowker honored as RAPS Fellow
Pearl Pathways Expansion featured on October 17 on CenterWatch News Online article, Pearl IRB expands compliance and consulting
Pearl Pathways featured on October 4th on Outsourcing-Pharma article, Pearl IRB to launch new consulting and regulatory compliance divisions
Pearl Pathways featured on October 3 onApplied Clinical Trials online article, Pearl Pathways to Parent Pearl IRB and Two New Sister Companies
Pearl Pathways featured on September 29 on Inside Indiana Business article, Life Science Company Unveils Expansion Plans
Pearl Press Release – Gretchen Miller Bowker Honored as RAPS Fellow. As thousands of regulatory compliance professionals converge in Indianapolis, Pearl Pathways’ COO honored- October 24, 2011. Click here to view full press release.
Gretchen Bowker co-authored article published in ACRP Monitor Article, Human Research Protection: Not Just an Obligation, a Career, page 21-22, September 2011
Gretchen Miller Bowker, Pearl Pathways COO 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.
Pearl Pathways Chief Operating Officer Gretchen Miller Bowker speaking at the annual IMDMC conference in Indianapolis, IN held on October 6, 2011. Title of talk is “FDA/OHRP efforts to modernize and revise clinical research regulations and guidance.” To learn more and register, click here.
Indiana Health Industry Forum 2011 BioFutures magazine features Pearl in its annual life science publication. To read articles entitled “Pearl IRB promotes clinical trials” and “The future of diagnostics in drug development” click here. See pages 8 and 30 for articles.
Pearl IRB receives national certification as a Women’s Business Enterprise: On November 18, 2010, Pearl Pathways/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).