Navigating global and local regulatory standards requires a proactive approach.

Partner with a CRO with in-depth regulatory expertise.

Regulatory standards are always changing, which is why you need a CRO with global and local regulatory knowledge across various regions. At Worldwide, we offer regulatory guidance across all phases of drug development.

Get started with Worldwide

Please let us know how we can help by filling out the form

Want a CRO partner who gives you their full attention?

You’re in the right place.

Watch Video
0 +

Therapeutic Experts

0 +

Countries, All Regions

Global Regulatory Support

With offices and employees around the globe, we provide crucial links to regulatory authorities and are skilled in the management of complex multinational submissions and meetings. Our team has supported diverse clinical trials across North America and Europe and is here to support your global regulatory needs.

Local Regulatory Support

With the frequently changing regulatory standards, you need a CRO that prioritizes continuous education. Although we are global, Worldwide has local teams that stay on top of the shifting regulatory standards and can help provide you with insights into local agency environments.

Diverse & Accessible Expertise

We’ve collected a wealth of experience across several indications and are well-versed in the complexities of clinical research, from trial logistics and regulatory engagement to scientific and medical expertise. Our experts are always accessible to you for anything you may need throughout the lifecycle of your program.

0 +

Therapeutic Experts

0 +

Countries, All Regions

0

Locations

Comprehensive Clinical Development Services Across All Phases

Worlwide provides top-notch regulatory services across the globe, including:

Icon list

U.S. Food and Drug Administration (FDA)

  • Pre-IND/pre-NDA meetings
  • Following the FDA’s Physician Labeling Rule
Icon list

European Medicines Agency (EMA)

  • Obtaining scientific advice and protocol assistance
  • Adhering to scientific guidelines issued by the EMA’s Committee for Medicinal Products for Human Use
Icon list

Regulatory Submissions & Applications

  • Smooth transitions from exploratory to confirmatory stages of investigational drugs
  • Expedited submissions for possible acceleration of the developmental process
  • Facilitated approval of applications to conduct clinical trials of new drugs
Icon list

Strategic Regulatory Engagement

  • Provide responses to regulatory body requests for information
  • Support for and participation in meetings with regulatory bodies
  • Document pharmaceutical quality/chemistry, manufacturing, and controls

Our Experts

Kellie MacLeod

Executive Vice President, Global Quality Assurance

Virgilio Garcia Lerma

Executive Director, Global Regulatory Strategist

Dana F. Durst

Executive Director, Site Activation & Regulatory Therapeutic Lead, Oncology

Aman Khera, MBA, FTOPRA, FRAPS

VP, Regulatory Science, Strategy, and Innovation

Client Testimonials

Hear from our past customers about their experience with Worldwide:

“From our point of view, what was really differentiating [Worldwide] was a detailed action plan when it came to site selection with respect to their local country, local regulatory knowledge. It was them demonstrating from similar studies showing how they had run those similar studies in a very competitive time [and with] very persuasive patient recruitment metrics. It was about how quickly they could start up comparable clinical trials, and their proposed use of real-world data to better optimize the clinical operation and execution of the clinical trial, again where to find patients, in which country preferable, and which sites.”

Global Head of Research, Clinical Development and Governance Operations Late Phase: Large Biopharma Customer

“They [Worldwide Clinical Trials] are focused on design and appropriate execution and reporting of clinical trial data. Everything else that’s necessary for that is all there to drive the success and the execution in reporting of acceptable clinical trial data… the mission is pretty clear. And you know, and I do think the flexibility comes across. Because when you deal with big CROs, if we make a change in a process because we think that’s the right thing to do, it’s not enough for them just to do it because we want it… They’re less concerned about that at Worldwide, in my experience. They’re more concerned about doing the right thing.”

Director of Clinical Operations Late Phase: Small Biopharmaceutical Customer

“Very good. Very competent. Lots of regulatory support. Global footprint. And I would say a trusted CRO. Well, a CRO that you can trust.”

Director, Clinical Supply Operations Late Phase: Small Biopharmaceutical Company, Rare Disease

Awards

On May 1st, Industry Standard Research (ISR) announced the 2024 Leadership Awards, recognizing Phase 2/3 CROs for comprehensive excellence across their capabilities, compatibility, expertise, quality, and reliability.

In 2023, Worldwide Clinical Trials was named Most Innovative Clinical Research Organization (CRO) by the Triangle Business Journal (TBJ). This awards program celebrates the achievements of individuals and companies making critical advancements in pharmaceuticals, biotech, ag tech, and beyond, in the Triangle region of North Carolina.

Worldwide Clinical Trials, Inc., (Worldwide) the industry’s leading global, midsize, full-service contract research organization (CRO), has been recognized for excellence and honored in five categories in the 2022 CRO Leadership Awards, based on primary market research from Industry Standard Research (ISR) Reports and presented by Clinical Leader and Life Science Leader magazines. This marks the ninth consecutive year that Worldwide has been recognized as a high-performing CRO based on direct survey feedback from pharmaceutical and biotech professionals.

Over 80% of respondents agreed that midsize CROs, such as Worldwide, provide a strong cultural fit while being able to pivot quickly based on changing customer needs.

Read the full report here