Experienced clinical research associate joins Pearl IRB

Clinical Research Associate - New Hire - Masheka Fuqua - Pearl PathwaysPearl IRB is pleased to announce the hiring of Masheka Fuqua as a Clinical Research Associate (CRA) serving biopharmaceutical, medical device, and diagnostics companies. Fuqua brings over a decade of clinical research experience to Pearl Pathways, including the coordination, management, and submissions of clinical trial activity across many therapeutic areas of research.

Fuqua’s decade of industry experience involves roles within clinical and healthcare market research at other organizations including direct work with sponsors, sites, and clinical research organizations (CROs). Diana Caldwell, President and CEO, shares, “Masheka delivers strong, balanced, and uncompromising research administration skills with integrity and credibility… Our clients will benefit from her broad industry experience that encompasses all aspects of clinical research, from site to sponsor to CRO. We are thrilled to have Masheka join the team.”

To read more, view the full press release.

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

Waylon Wright Marketing and Sales Associate TexasPearl Pathways announces the hiring of Waylon Wright as a Marketing and Sales Associate serving to expand the company’s commercialization efforts. Wright brings a diverse set of skills to the Pearl team, with over four years of sales, management, and marketing experience across both startups and multi-national corporations. In previous roles, Wright drove sales in a business to business setting, focusing on prospecting, building relationships, personal marketing, and interacting with small business owners.

Wright is the first full-time employee in Texas for Pearl Pathways and, in addition to his broad marketing and sales support responsibilities, he will support regional development and outreach efforts in Texas. Diana Caldwell, President and CEO shares, “Waylon brings strong writing, communication, and leadership skills to our team and represents our first stronghold in the Texas marketplace… He has broad clinical work experience having also worked as a behavior analyst in an applied health setting. We are thrilled to have Waylon join the team.”

Learn more about Waylon in our full press release.

Experienced project manager joins Pearl Pathways

shawn-knoppPearl Pathways is pleased to announce the hiring of Shawn Knopp, PhD as an Advisor serving medical device and biopharmaceutical life science companies.

Knopp brings to Pearl Pathways over 15 years of experience in multi-disciplinary life science roles including project management, product development, regulatory, engineering, and manufacturing.

Diana Caldwell, President and CEO shares, “Our clients will benefit from Shawn’s extensive leadership experience navigating a variety of regulatory compliance challenges in large multi-nationals and small startups… His past experience working as in independent consultant in the industry allows him to adapt to the dynamic needs of the biopharmaceutical and medical device companies we serve. We are so pleased to welcome Shawn to the team.”

To view the full press release, please click here.

Experienced quality analyst joins Pearl Pathways

phillip-bishopPearl Pathways is excited to announce the hiring of Phillip Bishop as a quality analyst. Bishop will help the Pearl team serve medical device and biopharmaceutical companies. Bishop brings 13 years of quality control (QC) laboratory experience to the Pearl Pathways team and recently held leadership roles in a good manufacturing practice (GMP) compliant QC laboratory at a top-tier contract manufacturer of sterile products. Diana Caldwell, President and CEO shares, “Phillip brings strong quality, manufacturing, and technical expertise as well as a deep understanding of validation documentation to the Pearl team. Our clients will benefit from his vast knowledge of quality compliance and quality assurance systems, CAPA, multiple test methods, and pharmacopeial work.”

You can read the full press release 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.

Pearl Pathways opens second location in Texas

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Pearl Pathways announces the addition of a second location in College Station, Texas. Through the support of the Research Valley Partnership and its Research Valley Innovation Center, Pearl Pathways has the unique opportunity of expanding into a new market.

Diana Caldwell, President and CEO of Pearl Pathways, notes “Texas is a perfect state for Pearl Pathways’ growth, and we are excited to be a part of the state’s growing life science community… The Research Valley Partnership is promoting unique, world-class cGLP and cGMP infrastructure and capabilities in Bryan-College Station to support startup life science medical device and biopharma companies, which is a core client segment for Pearl.”

For the full press release, click here.

Welcome Mary Anne Gfell to Pearl Pathways

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Pearl Pathways is excited to announce the addition of Mary Anne Gfell to the team as a Clinical Research Advisor.

Bringing over 15 years of experience in clinical research and quality compliance, Gfell is a key addition to the Pearl Pathways team. Prior to joining Pearl Pathways, she worked as a Global Project Manager at Covance, a multi-national CRO where she managed central laboratory services for Phase 1 through 4 clinical global studies. Gfell has extensive expertise in both drug and device trials, and started her career in a clinical setting as a Med Tech. She has further expertise in the creation and oversight of quality systems as well as the development of clinical protocols.

Gfell is an active Certified Clinical Research Coordinator (CCRC), a member of the Association for Clinical Research Professionals (ACRP), and holds her project management certification.

Click here to read the full press release.

Chad Pannucci joins Pearl Pathways as new Business Development Director

Pearl Pathways is excited to announce the hiring of Chad Pannucci as the new Business Development Director. Pannucci will be responsible for driving overall business development and sales of professional services within Pearl Pathways three business units including Pearl IRB, Pearl ReGXP, and Pearl IDEAS.

“Chad has a proven track record of driving business growth, launching new products and services, and influencing product development decisions in the fast changing medical device industry. His broad sales and product management skills will add value to our clients and help propel Pearl Pathways to the next level of growth,” shares President and CEO, Diana Caldwell.

For additional information, click here to read our full press release!

Pearl IRB announces AAHRPP accreditation

Pearl IRB is proud to announce its recent accreditation with the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction by demonstrating two primary techniques including extensive safeguards in all levels of the research operations and abiding by high standards for all research.

Pearl IRB is one of the four newly accredited organizations in the United States and one of only two AAHRPP accredited organizations in state of Indiana. Additionally, among the list of accredited organizations by AAHRPP include, The National Institutes of Health and Pfizer, Inc., which is the largest industry sponsor of clinical research.

Pearl IRB’s accreditation signifies its value in setting and following high standards for quality, ethics, and protection in all of its research.

Click here to read the full press release! To learn more about AAHRPP, visit www.aahrpp.org.

Need help with your clinical research study?  Contact us at info@pearlirb.com.

Pearl Pathways to partner with Brandwood Biomedical

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.

Additionally, 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!