Archive for the ‘Member Press Releases’ Category

Former FDA regulatory scientist joins Pearl Pathways

January 20, 2018


Contact: Waylon Wright
Pearl Pathways
Business: (317) 602-5479

INDIANAPOLIS, INDIANA – January 18, 2018— Pearl Pathways announces the hiring of Robert Seevers, PhD as Senior Advisor to serve biopharmaceutical companies.

Seevers brings over 40 years of experience in pharmaceutical research and development for both large and small molecules. His expertise includes CMC regulatory, cold chain shipping, setting global specifications, quality by design (QbD), global regulatory submissions, and interactions with global regulatory agencies. His knowledge spans all major therapeutic areas with specific expertise in CNS, Endocrine, Metabolism, Autoimmune, Oncology, Radiopharmaceuticals, and drug delivery systems. Seevers’ robust clinical research experience includes acting as a primary investigator, Vice-Chair of an Institutional Review Board, FDA Reviewer/Team Leader, and medical writer.

Seevers’ career includes eight years at the United States Food and Drug Administration (FDA). At FDA, Seevers served as a Team Leader responsible for managing a team of reviewers for the evaluation of CMC sections of INDs, NDAs and BLAs. Prior to joining Pearl Pathways, Seevers spent 16 years with Eli Lilly and Company in Regulatory Affairs, where he led the regulatory CMC submission strategy for drugs in preclinical development through their NDA/MAA submission and the approval process for both small and large molecules.

As Senior Advisor at Pearl Pathways, Seevers is responsible for the development of the regulatory strategy for early through late stage regulatory filings of both large and small molecules, interactions with global regulatory agencies, leading cross-functional CMC development teams, helping clients identify product development vendors (e.g. CROs, CMOs, contract laboratories), and will serve on Pearl IRB, an AAHRPP accredited Independent Review Board.

Seevers is a member of the United States Pharmacopeia Packaging, Storing, and Distribution Expert Committee, acts as a Stability Consultant for the World Health Organization (WHO), speaks regularly at nation and international life science conferences, and continues to be an active writer of industry publications.

Diana Caldwell, President and CEO shares, “Our clients will benefit from Robert’s unique life science portfolio as an ex-FDA regulator coupled with extensive leadership experience within the biopharmaceutical industry. His dual-sided industry experience will be invaluable for our clients to navigate a variety of regulatory compliance challenges in both large multi-national companies and small startups. He brings expert technical knowledge of CMC development, drug substance synthetic processes, cold-chain shipping, radiopharmaceuticals, and global regulatory submissions including INDs, NDAs, and BLAs. We are thrilled to have Robert join our team.”

About Pearl Pathways
Pearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, unyielding ethics, and efficient services through our team of experts. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Our AAHRPP accredited central IRB, Pearl IRB, supports all aspects of human research.
To learn more, please visit us at, call us at (317) 899-9341, or email Pearl Pathways is headquartered in Indianapolis, Indiana, with a regional office in Houston, Texas, and is AAHRPP accredited and a WBENC certified woman owned business.

For media inquiries, contact


Apexian Pharmaceuticals is Closing a Series A Round to Initiate Phase 1 Trial

December 4, 2017

Apexian Logo Font


Indianapolis, IN – November 29, 2017 – Apexian Pharmaceuticals, an Indiana-based clinical stage biotechnology company developing novel compounds to treat cancer, announced today that they are closing their Series A round. This financing follows previous investments as well as numerous grants and awards by the company since its founding. Proceeds will be used to initiate their phase 1 clinical study for APX3330 a novel first in class oral treatment for patients with cancer.


APX3330, the lead molecule for Apexian has a unique dual biological role targeting the APE1/Ref-1 protein.  The APE1 protein is a critical molecular “switch” controlling the activity of cancer regulatory proteins, including transcription factors HIF-1-alpha, STAT3, NF-kappa B, and AP-1. The Investigational New Drug application was issued based on robust non-clinical data and a safety database of over 422 patients in non-cancer studies. In addition, the data identified APE1/Ref-1 protein also plays a critical role in the repair of neuronal DNA that has been damaged through oxidative mechanisms which are common with platinum-containing chemotherapy agents. Apexian has developed robust non-clinical data demonstrating APX3330 prevents and/or reverses such damage and is the basis for pursuing an indication for Chemotherapy Induced Peripheral Neuropathy (CIPN).


Elevate Ventures, a venture development organization based in Indiana, committed funding through their Indiana 21st Century Research & Technology Fund, a direct investment vehicle overseen by the Indiana Economic Development Corporation positioned to support early-stage high-growth companies. “Apexian Pharmaceuticals has an impressive body of preclinical work in an exciting new target to treat cancer,” said Elevate Ventures Chief Executive Officer Chris LaMothe. “We look forward to joining other sophisticated investors to see this molecule tested in the clinical setting.”


Apexian Pharmaceuticals President and Chief Executive Officer Steve Carchedi commented: “We are very pleased to have an Indiana group, like Elevate Ventures join with others to enable this key data to be generated for our lead molecule. Developing a first-in-class oral molecule to treat pancreatic, colon and other difficult to treat cancers, is at the core of our mission. Cancer patients are truly waiting for novel treatments to attack these deadly diseases.”


About Elevate Ventures
Elevate Ventures nurtures and develops emerging and existing high-potential businesses into high-performing, Indiana-based companies. Elevate Ventures accomplishes this by providing access to capital, rigorous business analysis and robust advisory services that connect companies with the right mix of resources businesses need to succeed long-term. To learn more about its team and funds under management, visit


About Apexian Pharmaceuticals

Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs. Apexian’s lead drug candidate APX3330, is an oral first in class novel inhibitor of the APE1 protein, a critical node in cancer cell signaling. To learn more about Apexian Pharmaceuticals, please visit the company’s website at


Media Contact:


Telephone: 844-463-3330 x113

Inscope Medical Solutions Launches First Laryngoscope with Integrated Suction

November 6, 2017

Available for demo at ACEP17, Inscope Direct cuts airway intubation time nearly in half when secretions are present

WASHINGTON–(BUSINESS WIRE)–Inscope Medical Solutions, an innovative medical device company, today announces the first laryngoscope with integrated, controllable suction. The Inscope Direct is a disposable laryngoscope that allows clinicians to maintain a clear view of the airway. Designed to be the best choice for trauma intubations, the device eliminates the need to juggle between yankauer suction and the endotracheal tube while securing the airway. The device is available for demo during the American College of Emergency Physicians Scientific Assembly (ACEP), at booth #2411, Oct. 29 – Nov. 1, 2017.

“Using the Inscope Direct is addicting. It’s easy to use and the controllable suction in the mouth throughout procedures keeps the right hand free to focus on passing the endotracheal tube”

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Inscope Direct’s integrated suction removes secretions allowing a clear view of vocal cords for easy placement of the endotracheal tube. The device features a built-in LED light source and an anti-clog design with two controllable suction inlets eliminating the need for a yankauer suction catheter as it easily removes existing and re-accumulating secretions. Inscope Direct connects to standard suction tubing and is compatible with wall suction and powered portable suction. The convenient MAC 3.5 blade size fits most adults and each device is disposable to eliminate the risk of cross contamination.

“Using the Inscope Direct is addicting. It’s easy to use and the controllable suction in the mouth throughout procedures keeps the right hand free to focus on passing the endotracheal tube,” said Co-founder and Chief Medical Officer, Dr. Mary Nan Mallory. “Being able to easily suction while starting and throughout the intubation process is a game changer – it makes the first view a clear view, simplifying direct laryngoscopy every time.”

“Inscope Direct was born out of a real-life need following an incident where a founding physician had to treat a patient with life-threatening injuries, but struggled through the intubation process by juggling multiple pieces of equipment to clear the airway and pass the breathing tube. Every second is critical in emergency situations, and we knew there just had to be a better way,” said Co-founder and CEO Maggie Galloway. “We are thrilled to bring the Inscope Direct to market – not only for emergency intubations, but also planned intubations when secretions can unexpectedly become an issue. Now with the Inscope Direct, clinicians have at their disposal a tool that makes the intubation process more efficient and can improve outcomes for patients.”

In addition to the Inscope Direct, Inscope Medical plans to leverage its existing integrated suction technology in a forthcoming video laryngoscope.

To learn more, visit Inscope Medical Solutions at ACEP17 in booth 2411 in the main expo or at the Innovation Playground in innovateED for a hands-on demo. For more information on Inscope Direct visit

About Inscope Medical Solutions

Inscope Medical Solutions is an innovative medical device company located in Jeffersonville, IN. Their first product, the Inscope Direct, is the first laryngoscope to integrate controllable suction to quickly remove secretions for a clear view of vocal cords allowing easy placement of the endotracheal tube. The company has won multiple awards for the Inscope Direct, including, JEMS 2017 Hot Product award at EMS Today Conference, Indiana Innovation Showcase winner, and a finalist for the 2017 Indiana Life Sciences Summit New Venture Competition. To learn more, please visit and follow us on LinkedIn, Twitter @inscopemedical, or Facebook.


BLASTmedia for Inscope Medical Solutions
Emily Darr, 317-806-1900 ext. 121

Singota Solutions announces partnership with

October 19, 2017

Singota Solutions, a pharmaceutical contract development and manufacturing organization, expands service offerings through partnership with, a clinical trial logistics automation service.

graphs on tablet shutterstock_105421988Bloomington, IN (October 18, 2017)–Singota Solutions announced its partnership with to enhance outsourced management of clinical trial supplies. The partnership will benefit pharmaceutical firms in the clinical trial stage looking to streamline the tedious process of reordering and managing supplies.’s Clinical Trial Logistical Planning platform adapts, predicts, and responds to any clinical trial logistics scenario. The technology integrates directly into clinical trial data sources, reducing administrative burden to keep study sites provisioned with fresh supplies by utilizing automated supply ordering, resupply, and predictive forecasting.

Singota provides storage and materials management in its GMP warehouse that contains a range of storage conditions including 15-25°C, 2-8°C, -20°C, -80°C. Singota’s supply chain services include inventory management, expedited shipping services, and technical expertise in cold chain processes. In addition, Singota provides the pharmaceutical industry with state-of-the-art robotic aseptic manufacturing, formulation development, analytical testing, and labeling and kitting operations.

Singota’s ERP System is tightly integrated with’s technology platform. Once needs are established with the trial specific replenishment algorithms created by, Singota prepares materials and kits as necessary, and ships to trial sites as directed by’s technologies. The combined expertise of Singota and enables a breakthrough in clinical trial material operations proven to reduce delivery times, supply waste, and material costs, driving overall trial efficiency.

For more information, please contact Singota – or 812.961.1700.
About Singota Solutions
Singota Solutions is a service provider to the pharmaceutical, animal health, and medical device industries. Founded in 2006 as BioConvergence, the company is a woman-owned business operating in a 72,000-square foot facility in Bloomington, Indiana. The company’s service lines include aseptic manufacturing, supply chain operations, drug formulation development, analytical methods development & testing activities, and labeling & kitting operations. For more information, please visit

About is a clinical trial logistics automation service. The company uses a modern, data-driven technology platform with predictive analytics to enable patient-centered, automated, and end-to-end integrated services for clinical trial supplies. Trial data powers automated, just-in-time delivery of drugs and ancillary clinical supplies to study sites across the globe. For more information, please visit

B-Start Selects 2017 Startups

October 18, 2017


Media Contact:                                                                               

Anne McCombe

Project Manager, BEDC

(812) 335-7346



B-Start Selects 2017 Startups

Bloomington, IN (October 18, 2017) – B-Start, a pre-accelerator program for early-stage startups in Bloomington, announced its 2017 cohort today. Eleven startups were selected to participate in the 22-week program during which they will attend workshops in lean business concepts, customer acquisition, fundraising, marketing and more.


The program was opened to all Bloomington residents this year, including students from Indiana University and Ivy Tech Community College as in past years. B-Start has ushered 18 startups through the program since it was launched in 2015, with 7 still actively working on their businesses. In total, B-Starters have hired 5 new employees, and 3 have gone on to successfully participate in local business pitch competitions.


The newest group of B-Start participants focuses on a wide variety of industries. The eleven participants include:

  • Adventure Field Guides: Marketplace of trip guides made by a community of outdoor influencers
  • Be-u-tiful: Online marketplace that helps review and sell hair care products
  • Bot Maven: Software that creates bots for event promotions
  • Codemoji: Coding platform for kids using emojis
  • Community Carbon Exchange: Platform that facilities the financial exchange of personal carbon offsets between producers and consumers
  • Elephants on Mars: Virtual reality arcade to explore immersive VR and develop new technology
  • Eqlsr: Blockchain platform to share, curate, collaborate and listen to music
  • Nomad Chest: Platform for renting clothing to travelers
  • Rent My Window: Auction platform for brick-and-mortar businesses and advertisers
  • Sharon: Auction platform for brick-and-mortar businesses and advertisers
  • Thumb: Long-distance ride sharing platform for college students


“We are now in the third year of our B-start program, and are really excited to have non-students participating this year alongside students” said Anne McCombe, Project Manager of the BEDC. “Creating new businesses and plugging them in to the startup ecosystem in Bloomington is the goal of the B-Start program and this new cohort looks like one of our strongest yet.”


B-Start hosted a kickoff reception with the startups and business community on Wednesday, October 18th. Each of the B-Start participants will be paired with a local Bloomington entrepreneur who will serve as a mentor. The program culminates in a final Demo Day in March 2018 where the startups will deliver a 5-minute pitch with the chance to win cash prizes based on a panel of judges.


Founding sponsors for B-Start are Cook Group, Inc., Indiana University Office of the Vice President for Engagement, and The Gayle & Bill Cook Center for Entrepreneurship at Ivy Tech Community College Bloomington. For a full list of mentors, startups, and sponsors visit


About B-Start

B-Start is a pre-accelerator program of the Bloomington Economic Development Corporation (BEDC) to help launch for-profit innovation-driven businesses in Bloomington, Indiana. B-Start participants are at the earliest stage of their business development and are coached through a comprehensive process of cohort activities and individualized mentorship over the course of the program to build a foundation for acceleration. For more information, visit


About the BEDC

The BEDC is a not-for-profit organization dedicated to the retention, development and attraction of quality jobs in Monroe County. The BEDC is led by a partnership of private industry leaders, the City of Bloomington, Monroe County, Indiana University and Ivy Tech Community College–Bloomington. For more information, visit


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VisionTech Partners, Pearl Pathways Form Alliance to Fuel Growth in Indiana’s Life Sciences Startup Community

September 27, 2017

For Immediate Release

INDIANAPOLIS, Indiana (August 30, 2017) – – VisionTech Partners, the parent of Indiana’s most active angel investing group, and Pearl Pathways, a provider of life sciences product development services, have joined forces to fuel Indiana’s life sciences startup community, which includes biopharmaceutical, medical device and diagnostics technology.


The VisionTech Partners-Pearl Pathways alliance will focus on three essential goals. First, identify the most promising early stage/early growth companies for potential investment by VisionTech’s statewide network of angel investors. Second, connect entrepreneurs with individuals who have already achieved success in the life sciences and are willing to serve as mentors and business advisors. And finally, provide entrepreneurs with access to the highly specialized services required to negotiate the FDA approval process.


VisionTech Partners Executive Director Ben Pidgeon said both companies are eager to leverage their respective strengths through the alliance, which will formally launch Thursday, August 31, at VisionTech Angels’ “Pitch Night” in Indianapolis, featuring two life sciences startups.


“VisionTech Partners is extremely committed to growing Indiana’s life sciences industry and we’ve proven ourselves to be a valuable contributor to this effort as a source of financial and human capital. Of the 24 portfolio companies our angel network has invested in, 10 are in the life sciences and healthcare space; it’s definitely a sweet spot,” said Pidgeon.


“The alliance with Pearl Pathways will not only ensure a high quality deal flow, it will also help us make better investment decisions. Most of these companies must secure FDA approval in order to commercialize their drug, device or diagnostic tool. Pearl Pathways will, in effect, be VisionTech Partners’ resident expert on all things FDA,” he added.


Based in Indianapolis, Pearl Pathways is a life science product development services company that provides clinical research, regulatory, quality compliance, and independent review board services to life sciences companies. Among Pearl Pathways’ clientele are five of the top 20 medical device companies and six of the top 11 pharmaceutical companies in the world.


The balance of their business, said President and CEO Diana Caldwell, is startup companies with pre-commercialization technology that need access to early stage or “seed” funding provided by groups like VisionTech Partners.


“VisionTech Partners is unique in the angel investing space. Yes, they are a source of capital, but more importantly, they have deep experience and success in the life sciences industry. They also have a chapter composed entirely of physicians. These are the people who are around medical technology on a daily basis and have knowledge and insight few investors have. Partnering with VisionTech will not only open doors for our clients, startup companies across Indiana will benefit from the combined talents and resources of our two companies,” Caldwell said.


About VisionTech Partners I VisionTech Angels

Founded in 2008, VisionTech Partners is a privately held company focused on linking investors to high-potential early-stage companies. Headquartered in Indianapolis, among the nation’s most vibrant innovation regions, VisionTech is where inventors, entrepreneurs, investors, universities, and strategic partners convene to share, fund, and launch novel technologies. VisionTech Angels has chapters in Bloomington, Fort Wayne, Indianapolis, Lafayette, and an Affinity chapter, AngelBom.


About Pearl Pathways.

Founded in 2010, Pearl Pathways is a comprehensive life science product development consulting services company with expertise in regulatory, quality compliance, and clinical trial services including an AAHRPP accredited commercial IRB, Pearl IRB. Pearl Pathways works with clients’ clinical teams, in-house regulatory experts, the quality compliance specialists, quality auditors, and the senior leadership team to get life saving diagnostics and therapeutics on the market sooner.

Contact: Melanie Lux,, 803.331.4794

Contact: Waylon Wright,, 317.602.5479

National Cancer Institute selects Apexian Pharmaceuticals to participate in the Small Business Innovation Research (SBIR) Initiative program

September 26, 2017

 Apexian Logo Font



National Cancer Institute selects Apexian Pharmaceuticals to participate in the Small Business Innovation Research (SBIR) Initiative program


Indianapolis, IN – September 25, 2017 –Apexian Pharmaceuticals is pleased to announce that the National Cancer Institute (NCI) has selected the company to participate in its highly competitive Small Business Innovation Research (SBIR) Investor Initiatives program, that encourages domestic small businesses to engage in Research and Development (R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. As part of this program, Apexian Pharmaceuticals was selected to present at the BioNetwork Partnering Summit, being held in Laguna Niguel, California on October 23-25 2017. This work was supported by NCI SBIR grant 11196090.  Apexian’s Chief Medical Officer, Dr. Rich Messmann, will be speaking about the development of the company’s lead molecule APX3330, and its effect upon APE1/Ref 1, a dual function protein that is a critical signaling node in cancer cells that also facilitates repair of oxidative damage to DNA.


In extensive preclinical testing, much of it conducted by Dr. Mark Kelley, Apexian’s Chief Scientific Officer, and Associate Director of Basic Science Research at the Indiana University Simon Cancer Center, and as summarized in a recent Nature Precision Oncology article (Shah et al. 2017 npj Precision Oncology), APX3330 provided robust anti-cancer effect by inhibiting the activation of cancer regulatory proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3, as well as an ability to prevent and reverse the oxidative damage -called chemotherapy induced peripheral neuropathy or CIPN- caused by platinum-containing chemotherapy agents such as oxaliplatin and cisplatin.  The U.S. Food and Drug Administration has issued an Investigational New Drug license to Apexian to commence human testing of APX3330 and accrual into the initial study will begin in the near future. Details of the trial, including contact information on participating centers, will be found at


Steve Carchedi, President and Chief Executive Officer of Apexian Pharmaceuticals, commented:  “We are very honored by the NCI’s decision and excited to tell the Apexian story at the BioNetwork event. Cancer patients need additional safe and effective therapy, and the prospect that APX3330 not only provides anti-cancer effect, but may also prevent or reverse the debilitating effects of CIPN could fundamentally change the manner in which certain cancers are treated. We are looking forward to initiating our clinical study in an area with such high unmet need.”


About Apexian Pharmaceuticals

Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs.  Apexian’s lead drug candidate is named APX3330. To learn more about Apexian Pharmaceuticals, please visit the company’s website at


Media Contact:


Telephone: 844-463-3330 x113

CRI Celebrates 30 Years in the Medical Device Industry

August 18, 2017
Celebrating 30 Years

For Immediate Release

CRI Medical Devices is proudly celebrating its 30th year in business this September 17, 2017.

Established on September 17, 1987, CRI built its foundation through the development of technology that enabled catheters to better navigate the inner passages of the body during surgery. This technology was based upon the use of nitinol wire; an industry standard material still to this day.

Over the past 30 years, CRI has continued to focus on the development and manufacturing of catheters and other custom medical devices. Specialties include high-volume assembly, extrusion, domestic and international regulatory services as well as marketing and sales of its Thomas Medical branded, proprietary women’s health

In 2008, owner John Steen, PhD converted CRI to an employee-owned company. In 2010, CRI became 100% employee-owned and is still an ESOP today. This business model has created an environment where its highly dedicated employee-stock holders have a vested interest in the success of CRI. Dr. Steen has been with CRI since 1991 and currently serves as Chairman of The Board and assists with export activities for Thomas Medical.

Today, CRI is still headquartered in Indianapolis, IN with locations in Minnesota, Ireland and Costa Rica. CRI has expanded its capabilities and services globally, but has not forgotten the importance of local customer service and quality manufacturing practices. “After 30 years of continued growth, the future for CRI is bright.” stated Dr. Steen.

Full post and CRI Website

Pearl IRB becomes a SMART IRB participating institution

August 18, 2017

August 16, 2017


 Contact: Waylon Wright

Pearl IRB

Business: (317) 602-5479

Cell: (832) 942-4152




INDIANAPOLIS, INDIANA – August 16, 2017 — Pearl IRB is pleased to announce that we have joined SMART IRB, a platform to ease common challenges and burdens associated with initiating multisite research. SMART IRB is a collaborative initiative supported by the National Center for Advancing Translational Sciences (NCATS) and led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy.

Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across a national consortium of institutions. Together with SMART IRB, we will shape the future of multisite research across the nation, creating a network that will foster and enhance collaboration.

Pearl IRB strives to deliver superior independent review board services to improve the clinical research process thereby delivering new therapeutics and diagnostics to patients sooner.

The goal of SMART IRB is to streamline the IRB review process in multisite research, help investigators obtain trial results faster and, ultimately, advance the development of new diagnostics, treatments, and preventative measures for patients, while maintaining strong human research protections, oversight, and regulatory compliance.

Under the SMART IRB Agreement, investigators conducting multisite research may request that participating institutions rely on the review of a single IRB, and institutions may elect to do so on a study-by-study basis.


A full list of participating institutions and more information may be found at

For information about how you can leverage SMART IRB for your research, please contact us today.

About Pearl IRB

Pearl IRB is an independent institutional review board, fully accredited by the Association for the Accreditation of Human Research Protection Program Inc. (AAHRPP).  Pearl IRB manages the local and central IRB needs for large and small institutions, principal investigators, CROs, and sponsors. Our vision is to improve the clinical research process which will lead to delivering therapeutics and diagnostics to patients sooner. Whether the research is a small single site project or a complex multi-center study, we can help.

Pearl IRB is part of Pearl Pathways, a comprehensive life science product development services company. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Whether you are small startup, still in the pre-commercialization stage, or a large multinational company with several products on the market, Pearl Pathways is equipped to serve you. Learn more at

To learn more, please visit us at, call us at (317) 899-9341, or email Pearl IRB is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact


Pearl Pathways Hires Masheka Fuqua

May 25, 2017

May 25, 2017




Contact: Waylon Wright

Pearl Pathways

Business: (317) 602-5479

Cell: (832) 942-4152



Pearl Pathways Hires Masheka Fuqua


Experienced clinical research associate joins Pearl Pathways


INDIANAPOLIS, INDIANA – May 18, 2017 — Pearl Pathways announces the hiring Masheka Fuqua as a Clinical Research Associate serving biopharmaceutical, medical device, and diagnostic life science 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. Her 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). Fuqua’s in-depth understanding of FDA, ICH, and Good Clinical Practice regulations coupled with her strong clinical background and acumen in auditing and monitoring various regulatory documents make her a strong addition to the team. Masheka holds an MS in Health Science from Indiana State University, a B.S. in Business Management from Indiana Wesleyan University, and an A.A.S. in Funeral Service from Mid-America College of Funeral Service.

Diana Caldwell, President and CEO shares, “Masheka delivers strong, balanced, and uncompromising research administration skills with integrity and credibility. She deeply understands clinical study regulatory processes including IRB submissions. 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.”

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, call us at (317) 899-9341, or email Pearl Pathways is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact