Full-service Clinical Pharmacology Unit

Helping your drug development journey progress with our fit-for-purpose facility.  

With the ever-increasing complexity of Phase 1 trials, Worldwide Clinical Trials has you covered. Operating since 2005, studies are conducted in healthy volunteers, patients, and specialty populations. 

Your partner for integrated clinical and bioanalytical solutions.

Special Procedures and Evaluations 

We have the expertise and ability to conduct special procedures within our CPU such as CNS (comprehensive suite of cognitive assessments, EEG, and imaging), CSF (continuous and intermittent CSF collections, and blood and CSF PK comparisons), CV (Mortara surveyor system, Holter monitoring, 24-hour telemetry, early precision QT/TQT studies), and AME (equipped with a radiation safety officer and radiologist, we can accommodate pharmacy drug preparation and radioanalysis). 

Full Suite of Clinical Pharmacology Studies

We have the experience, expertise, and proven ability to take on all your clinical pharmacology studies so that you can move on to your next critical milestone. Our suite of studies includes FIH, Integrated SAD and MAD (includes FE, DDI, BA, EPQT), DDI, BE/BA, Food and Meal Timing Effect, PK/PD, AME/Mass Balance/Metabolite Profiling, Renal Impairment, Hepatic Impairment, Expert Precision QT and Thorough QT Evaluations Impairment, POC Studies in Patients, CSF Collection and Analysis, and Specialty Procedures such as biopsies, NG tube, and unique routes of administration.

cGMP Phase 1 Pharmacy & CLIA Safety Laboratory Onsite

We recently expanded our onsite pharmacy, giving us the ability to manufacture 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 is a huge advantage as it could save you thousands of dollars and months of time. Additionally, we also have an onsite CLIA certified safety laboratory fully dedicated to research studies. 

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Bed highly flexible, fit-for-purpose facility in San Antonio, TX

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Dose Full on Time in Clinic

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Year track record across a wide range of ClinPharm Studies from design to report 

Comprehensive Support Services for Phase 1

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Medical and Scientific Consultation

  • Concept and regulatory approach  
  • Protocol design  
  • Program development  
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Regulatory

  • Pre-IND/IND services  
  • Ethics review board submission
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Scientific and Medical Writing  

  • Protocols and synopsis  
  • Informed consent document  
  • Clinical study reports  
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Clinical Conduct  

  • Worldwide CPU Site  
  • QA approved Phase 1 global site network  
  • Recruitment of healthy and patient populations  
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Clinical and Medical Oversight  

  • Medical monitoring
  • Clinical monitoring 
  • Pharmacovigilance  
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Project Management

  • Oversees all aspects of study execution  
  • Tracks progress, costs, and timelines  
  • Multi-site feasibility and management  
  • Directs Project Communication  
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Data Management and Biostatistics

  • Phase 1 Focus and Expertise  
  • Dedicated Phase 1 Teams  
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Pharmacokinetic Team

  • PK/PD/Tox Analysis and Reports  
  • Consultation Services

Our Experts

Sherilyn Adcock, RPh, PhD

Chief Scientific Officer, Early Phase Development

Mike Mencer

Executive Vice President and General Manager, Early Phase

Lona Sheeran

Senior Vice President, Clinical Operations Early Phase

Olutola O Adetona, MD, MPH, CPI

Medical Director/Certified Principal Investigator – Early Phase Clinical Operations

Marie T. Simerly, PMP

Executive Director, Project Management Early Phase

Don’t just take our word for it. Hear what our sponsors have to say:

I think that what differentiates [Worldwide Clinical Trials] from other CROs is how efficient they operate, how responsive they resolve or do their issue-resolution. Those are the things that I can think of immediately that make me like to work with midsized CROs.

CEO and Head of Clinical Development Early Phase: Small Biotech Customer

I thought very highly of Worldwide Clinical Trials. I thought they were a good, solid CRO and certainly would have them included in any upcoming clinical development work.

Head of Regulatory Affairs Early Phase: Small Biotech Customer

It was an open, honest, but enthusiastic work environment that [Worldwide Clinical Trials] really provided. They paid attention to us as a small company…and they made us feel like one of their more important clients, even if we weren’t, and that was all the difference.

Senior Vice President of Program Operations Small Biopharmaceutical Customer

We really appreciate the strong collaborative partnership we’ve developed with Worldwide which is based on shared accountability. I see us awarding them more studies in the future.

Sr. Vice President of Clinical Development and CMS Clinical Stage Biotech Company

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