Life Sciences Company Unveils Expansion Plans

September 29, 2011

News Release

INDIANAPOLIS, IN - Pearl IRB, LLC, a privately owned commercial IRB (Institutional Review Board), has announced major expansion plans. Pearl Pathways, the new parent company, will be organized into three distinct and efficient business units.

Pearl IRB remains focused on expediting the clinical research process, by offering several wrap around services including medical writing, on demand clinical research staffing, research process and regulatory training, in addition to its core IRB Board Review services. Two branches will be added to the Pearl family – Pearl ReGXP and Pearl IDEAS. Pearl ReGXP accelerates global product registrations and approvals, and supports clients’ quality compliance initiatives with a team of regulatory compliance experts. Serving startups and small service providers, Pearl IDEAS is a boutique consulting group focused on turning ideas and inventions into life science solutions.

“Our clients shaped the direction of our future growth. We listened to the needs of existing and potential clients, and developed a family of businesses to support the regulatory and product development challenges facing bio-pharma and device companies of all sizes,” shares Diana Caldwell, President and CEO of Pearl Pathways.

According to Frost & Sullivan, pharmaceutical and biotech outsourcing is growing 10% annually.1 “The trend to outsource device and drug development is here to stay. Our life science clients require senior professionals with a comprehensive knowledge set in the industry to guide the product development pathway. These experts need to know clinical, regulatory strategies, manufacturing, quality compliance standards, business strategies and more. Our mix of business units allows us to provide that expertise,” states Gretchen Bowker, COO of Pearl Pathways.
Client feedback concerning the expansion has been extremely positive. "We value the breadth of Pearl's services. We can tap into their expertise for clinical, manufacturing, regulatory and quality, all in one team. For a smaller company such as ours, working with one company rather that three or four allows us to save time and trouble," shares Grace Deebo, Senior Vice President, Regulatory Affairs for Agile Therapeutics.

Caldwell says the expansion should create twenty additional positions over the next two years. These positions will require highly talented individuals with advanced degrees in science, engineering and medicine. According to a study sponsored by BioCrossroads, professionals working in the life science industry earn on average more than twice the annual salary in Indiana compared to the average of all other jobs.

To learn more about Pearl Pathways, visit www.pearlpathways.com or email info@pearlpathways.com.

About Pearl Pathways
Pearl Pathways is a comprehensive life science product development services company. Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three business units to serve you:

Pearl IRB is a full service commercial Independent Review Board that provides human research IRB reviews, IRB exemptions and waivers, and also offers support for research protocol/ICF medical writing, site assessments, and monitoring services.

Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GMP/GLP/GCP auditing services.

Pearl IDEAS provides strategic product development assistance, third party vendor selection and management strategies, due diligence services, and sales and marketing services for drug, biologic and device companies.

To learn more, please visit us at www.pearlpathways.com, call us at 317.899.9341, or email info@pearlpathways.com. Pearl Pathways is located in Indianapolis, Indiana, and is a WBENC certified woman owned business. For media inquiries, contact Diana Caldwell at dcaldwell@pearlpathways.com.

Source: Pearl Pathways