“A common thread among our Worldwide team members is a passion to take care of our customers – we’re always looking for ways to improve our partnerships,” said Mike Mencer, Executive Vice President and General Manager, Early Phase. “As part of an ongoing $5 million upgrade to our CPU, this expansion aligns with our culture of quality and our dedication to continuous improvement and innovation to meet our customers’ growing needs as we work together to improve the lives of patients around the world.”

Pharmacy upgrades included end-of-life equipment replacements and relocation for an expanded footprint within the CPU.

“Expanding our pharmacy in size enables us to expand in volume, providing additional opportunities and efficiencies for our customers,” said Lona Sheeran, Sr. Vice President, Clinical Operations, Early Phase. “We can now manufacture onsite, in real time, for Phase 1 studies per FDA guidance, allowing our customers the option to pivot on their dose while their study is ongoing. This service is unique and can save our customers thousands of dollars and months of time – a huge advantage in this fast-paced industry.”

Operating since 2005, Worldwide’s CPU is a 200-bed, fit-for-purpose facility. Within this unit, studies are conducted in healthy volunteers, patients, and specialty populations. The CPU is located one hour from Worldwide’s Bioanalytical Center of Excellence, offering a comprehensive approach that benefits customers through streamlined vendor management, consistent standards, technical expertise, and overall efficiencies such as seamless sample transfer and rapid processing.

For more information on Worldwide’s CPU and to take a tour, click here; and to take a tour of the Bioanalytical Center of Excellence, click here.

About Worldwide Clinical Trials:
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com.

Media Contact:
Jill Mastrangelo
Jill.Mastrangelo@Worldwide.com

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RESEARCH TRIANGLE PARK, N.C. – 15 February 2024 – Worldwide Clinical Trials (“Worldwide”), a privately held, leading global, full-service contract research organization (CRO), has launched the Rare Moments website to give the rare disease community an easily accessible space to connect, share stories, and uncover new possibilities and ways of thinking about rare diseases. The unique resource surfaces impactful, transformative stories from patients, family members, researchers, and others involved in rare disease care.

“We’ve heard from various rare disease community members that it’s difficult to stay updated on news, milestones, and developments in other rare diseases. The successes built out of one rare disease should and could be applied to another rare disease,” said Derek Ansel, Executive Director, Therapeutic Strategy Lead, Rare Disease for Worldwide Clinical Trials. “Those who live with, research, and treat rare diseases have a common bond, and there is power in sharing experiences as a community. By coming together in one place, these groups can learn about different viewpoints and discover new opportunities. Worldwide believes the voice of the patient should be an intrinsic part of rare disease research and care, and this website is one way we are working to amplify and spread that voice, as well as build connections and community.”

The Rare Moments website showcase experiences from diverse audiences that illustrate what it means to live with and work with rare diseases. Anyone can submit a Rare Moment, and they can be past experiences, significant highlights from the 2024 Rare Disease Week and Rare Disease Day, resources, and even hopes for the future. While the stories will evolve over time, several featured stories went live with the website’s launch on 1 February 2024. Rare disease community members are encouraged to submit their own Rare Moments leading up to Rare Disease Day on 29 February and beyond.

Around the world, 300 million people have a rare disease, and 72 percent of those diseases have genetic origins (source). A rare disease is generally considered to be a disease that affects fewer than 200,000 people in the United States or 5 in 10,000 people in the European Union at any given time. Patient populations for these diseases are small and geographically widespread – a challenge for achieving access to conduct patient education and rare disease clinical research.

Learn more about Worldwide’s commitment to excellence in rare disease clinical trial design here.

About Worldwide Clinical Trials:

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com.

Media Contact:
Jill Mastrangelo
Director, Global Corporate Communications
Jill.Mastrangelo@Worldwide.com

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RESEARCH TRIANGLE PARK, N.C. – 08 FEBRUARY 2024 – Worldwide Clinical Trials, a leading global full-service contract research organization (CRO), has released results of a recent industry survey. The report examines changing perceptions about large and midsize CROs within the pharmaceutical and biotech sectors. Derived from a diverse respondent base of clinical trial sponsors—including emerging, small, midsize, and large companies in the United States and Europe(1) —the findings unveil concerns about the impact of complicated market dynamics on large CRO performance and service delivery.

“This survey data reveals the current challenges pharma and biotech sponsors are facing while highlighting the importance of CRO partnerships and flexibility. We hear from our sponsors all the time that they want transparent communication, responsiveness, and personalized attention – they need these things for reassurance and to create a shared sense of ownership, especially during times of market uncertainty and CRO shake-ups,” stated Worldwide’s president and CEO, Peter Benton. He added, “Regardless of sponsor size, at the core of successful clinical research programs are high levels of customer service, ongoing proactive communication and collaboration, and the flexibility to adapt in an everchanging clinical landscape.”

Samir Shah, industry veteran and principal of Shah Pharma Consulting Services LLC, recently examined the structural changes across distinct customer segmentations, specifically midsize to large pharma and biotech, and the implications for CROs needing to further configure solutions based on their specific operating model. Shah commented, “Worldwide’s findings are supported by a McKinsey & Company report that includes data from the biotech segment and provides insights on how CROs can improve their partnership models. Both reports underscore the importance of CROs offering flexible and customized solutions that account for the size and needs of a specific customer.”

Large CRO Segment Dynamics

Of note, nearly 80% of survey respondents felt the “one-stop-shop” claim frequently marketed by large CROs is not a cost-effective business model, and often does not result in seamlessly integrated service delivery. Additionally, 50% of respondents shared that large CRO instability has impacted their willingness to partner due to project team disruptions, lack of access to top talent, poor service delivery, and more. In addition:

• 75% of respondents raised concerns regarding a lack of personalized attention.
• 71% of respondents voiced apprehension about higher clinical development costs when working with large CROs.
• 70% expressed worry about potential project team disruptions leading to extended turnaround times and deliverables.
• 69% were anxious about inefficiencies arising from operational differences between poorly integrated companies.

Challenges also surfaced among survey respondents regarding the talent, service delivery, and client prioritization offered by large CROs. Notably, 69% reported encountering a “B” team despite assurances of an “A” team, and 62% expressed reservations about their inability to provide consistent support to customers of all sizes.

These misgivings seem to underpin the anticipated outsourcing activity shift from 41% to 46% (net gain of 5%) from large CROs to midsize CROs over the next three years, as revealed by the data. This change in outsourcing behavior was demonstrated across trial sponsors from all company sizes and geographies. This signals a notable change in the market, strongest among midsize and large biopharma sponsors in Europe and the US.

Midsize CRO Takeaways

Survey participants noted that their inclination toward midsize CROs is driven by their belief that midsize CROs deliver more agility, personalized attention, and an advantageous balance of cost and value.

More than 80% of respondents concurred that midsize CROs not only align well culturally but also demonstrate the ability to swiftly adapt to evolving customer needs. Moreover, among the attributes respondents noted as beneficial factors when working with midsize CROs:

• 83% cited “agility.”
• 81% cited “rapid escalation of study-related issues.”
• 80% cited “access to senior-level scientific and medical expertise.”
• 79% cited “personalized attention/greater customer focus.”

For more detailed insights and access to the complete survey report, click here.

About Worldwide Clinical Trials:

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,400 team members. For more information, visit www.worldwide.com.

Disclaimer: When accessing the industry survey report, please note – The content of this report is proprietary to Worldwide Clinical Trials. Please note, no part of this report may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Worldwide Clinical Trials except in the case of quotations embodied in reviews and non-commercial uses including press and media outlets. Any unauthorized reproduction or distribution of this report or any portion thereof may result in legal action taken by Worldwide Clinical Trials to protect its rights. For permissions or inquiries, please contact: Media@Worldwide.com.

1. The web-based, quantitative research survey was fielded with key CRO decision makers across emerging, small, midsize, and large pharma and biotech companies (N=140). Regional representation included 66% US/Canada (N=93), 34% Europe (N=47). The research was conducted by a third-party market research partner, and research participants were recruited from a panel of experts involved in the evaluation, selection, and use of CROs.

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RESEARCH TRIANGLE PARK, N.C. – 12 December 2023 – Worldwide Clinical Trials (“Worldwide”), a privately held, leading global, full-service contract research organization (“CRO”), has announced the closing of its previously announced recapitalization that gives funds managed by Kohlberg & Company, LLC (“Kohlberg”), a leading private equity firm with over 35 years of experience partnering with management and companies like Worldwide, a majority stake in the company. Middle-market private equity firm TJC, which has been Worldwide’s sole investor since 2007, retains a meaningful minority equity stake in the CRO.

“This is a significant milestone for Worldwide – one that positions us for further growth and expands our ability to deliver best in class partnerships for our customers while cultivating a culture for our team members to do their best, mission-oriented work,” said Peter Benton, President and CEO, Worldwide Clinical Trials. “Our customers have told us directly that our responsive, flexible, and accessible partnership model benefits them. This investment by Kohlberg, and continued investment by TJC, elevates our approach to best support our customers and continue delivering customized clinical research programs.”

With this transaction, Matt Jennings, Operating Partner of Kohlberg, becomes Chairman of Worldwide’s Board of Directors. Worldwide remains a privately held company with no other changes to its leadership team, employee base, or customer experience.

“The addition of Worldwide Clinical Trials to the Kohlberg portfolio builds a vital piece of our pharma services ‘ecosystem’ by which we have thoughtfully connected non-competing companies that are driven by similar missions and visions – ultimately, to help improve the lives of patients around the world,” said Jennings. “Worldwide’s achievements to date, and its promising growth trajectory, are unmatched in the industry. We look forward to bringing valuable synergies and additional investment opportunities for the CRO in the years to come.”

As a result of its deliberate, therapeutically focused growth strategy, aligned with industry trends and customer needs, Worldwide has demonstrated market leading year-over-year growth since 2019. The company has experienced consistent increases in its annual Late Phase studies across the key therapeutic areas of neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease; and has made significant investments to expand its Early Phase services and capabilities, including opening a state-of-the-art Bioanalytical Center of Excellence and launching its large molecule services in 2022.

“Worldwide Clinical Trials is now a valuable part of Kohlberg’s Pharmaceutical and Medical Products & Services industry practice, joining companies that are committed to offering high-value services to the life sciences industry, like PCI Pharma Services and Trinity Life Sciences, to create trusted collaborations while operating independently,” said Chris Anderson, Partner at Kohlberg. “For Worldwide, this means accelerating its next growth journey phase and continuing to expertly partner with its customers to bring new life-changing medications and treatments to patients around the world, and we are excited to support that imperative mission.”

Over the past 10 years, Worldwide has been recognized as a top CRO in the annual CRO Leadership Awards, based on primary market research from the Industry Standard Report (ISR) – earning top marks in the categories of Capabilities, Compatibility, Expertise, Quality, and Reliability. In 2023, the company was honored as the year’s Most Innovative CRO in TBJ’s Life Sciences Awards, a program that celebrates the achievements of companies making critical advancements in pharmaceuticals, biotech, and beyond.

To learn more about Worldwide or to connect, visit www.Worldwide.com.

About Worldwide Clinical Trials:
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program. Worldwide is therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic and inflammatory disease. Its global footprint spans nearly 60 countries with more than 3,300 team members. For more information, visit www.worldwide.com.

About Kohlberg & Company:
Kohlberg is a leading U.S. middle market private equity firm based in Mount Kisco, New York. Over the firm’s 36-year history, the firm has organized 11 private equity vehicles totaling in aggregate over $14 billion. Since inception, the firm’s private equity investments have generated over $10 billion in realized returns with no realized losses since Fund VI (2007 vintage). The firm invests in leading middle market businesses that are identified through its rigorous thematic research and the firm’s White Paper Program in its six core practice areas. For more information, please visit www.kohlberg.com.

About TJC, L.P.:
TJC, founded in 1982, is a middle-market private equity firm that has raised funds with original capital commitments in excess of $22 billion with a 40-year track record of investing in and contributing to the growth of many businesses across a wide range of industries, including Diversified Industrials; Technology, Telecom & Power; Logistics & Supply Chain and Consumer & Healthcare. The senior investment team has been investing together for over 20 years, and they are supported by the Operations Management Group, which was established in 1988 to initiate and support operational improvements in portfolio companies. TJC has offices in New York, Miami, Chicago, and Stamford. For more information, visit: www.tjclp.com.

Media Contacts:
For Worldwide:
Jill Mastrangelo
Director, Global Corporate Communications
Jill.Mastrangelo@Worldwide.com

For Kohlberg:
Sophia Templin and Elizabeth Chaconas
Kohlberg-US@fgsglobal.com

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*Press release and imagery courtesy of the American Heart Association

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RESEARCH TRIANGLE PARK, N.C. – 29 November 2023 – Worldwide Clinical Trials (Worldwide), a leading global, full-service contract research organization (CRO), has appointed Jayaprakash (JP) Kotha, MBBS, Ph.D, ASCP (SH), as Vice President, Bioanalytical. Kotha now leads lab operations and all activities in Worldwide’s Bioanalytical Center of Excellence, located in Austin, Texas.

The Bioanalytical Lab at Worldwide continues to grow with the industry to provide customers with small and large molecule bioanalysis, PK/PD analysis, and genotyping expertise. In 2022, the company opened the Bioanalytical Center of Excellence, a state-of-the-art, 60,000 square foot facility outfitted with a full automation suite, modern infrastructure, and efficient, fit-for-purpose lab space to flexibly support current and future research demands while enabling optimized workflows to ensure critical customer timelines are met. The Bioanalytical Center of Excellence is also set up to meet and exceed the increasing demand within the large molecule bioanalytical testing services market with an additional 15,000 square foot lab dedicated to large molecule.

“JP’s extensive scientific background makes him the perfect fit to lead our Bioanalytical laboratory, particularly at a time when we are growing our service offerings to best meet the needs of our customers,” said Mike Mencer, Executive Vice President and General Manager, Early Phase. “I am confident that JP’s leadership will drive further success that helps our customers improve the lives of patients by bringing new drugs and treatments to market.”

“It is exciting to join the Worldwide Clinical Trials team, especially during a time of such transformation and progress,” said Kotha. “Worldwide is known for its specialized approach to bioanalytical services and clinical trials – one that prioritizes personalized partnerships and accessible technical expertise for its customers. I look forward to contributing greatly to the business.”

As a scientist with more than 25 years of diagnostic and research laboratory experience in cardiovascular, hematology, oncology, and immunology, Kotha is well versed in leading cross-functional teams engaged in clinical and translational research for the development of biologics and small-molecule therapeutics. He offers extensive experience in development and validation of bioanalytical assays for pharmacodynamic, pharmacokinetic, biomarker, and immunogenicity testing for novel therapeutics on diverse technological platforms and in guiding research scientists and project managers engaged in laboratory testing for clinical research.

Learn more about Worldwide’s bioanalytical services, click here.

About Worldwide Clinical Trials:
Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Our capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by our accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.

Anchored in our company’s scientific heritage, we are therapeutically focused on neuroscience, oncology, rare diseases, and cardiometabolic disorders. Our deep therapeutic knowledge and country-specific operational acumen enable us to develop flexible plans and quickly solve problems for our customers.

Our team of 3,300+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. We are united in cause with our customers to improve the lives of patients through new, innovative therapies.

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Media Contact:
Jill Mastrangelo
Jill.Mastrangelo@Worldwide.com

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