NDA Enabling Studies

Critical development milestones delivered with ease

Meeting drug interaction and other clinical pharmacology study timelines to complete your full NDA package while working on your pivotal Phase III study is a challenging requirement. Worldwide has the experience, the expertise, and the proven ability to take on all your clinical pharmacology studies so that you can move on to your next critical milestone.

Full Suite of Clinical Pharmacology Studies

  • First-in-Human
  • Integrated SAD and MAD (includes FE / DDI / BA / EPQT)
  • Drug-Drug Interaction
  • 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
  • Specialty Procedures (Biopsies, NG tube, and unique routes of administration)
First-in-Human Integrated SAD and MAD (includes FE / DDI / BA / EPQT) Drug-Drug Interaction BE / BA Food and Meal Timing Effect PK / PD AME / Mass Balance / Metabolite Profiling Renal Impairment Study Type & Design Hepatic Impairment Expert Precision QT and Thorough QT Evaluations Impairment POC Studies in Patients CSF Collection and Analysis Specialty Procedures (Biopsies, NG tube, and unique routes of administration)

As you plan for future development, our team at Worldwide is here to support you. 

  • Streamlined communication with a single study management point of contact for all clinical pharmacology studies
  • Immediate access to senior leadership for consultation and escalations
  • Expert advice on study design, including protocol and analysis plan development to accommodate conventional and nonconventional products
  • Fit-for-purpose facility co-located with our bioanalytical lab for efficient timelines and streamlined processes

Are you searching for a new partner to manage your bioanalytical needs? From method development or transfer to sample analysis and data generation, our state-of-the-art bioanalytical lab is fully prepared to assist, helping you streamline your outsourcing process. The benefits are clear: our co-located Phase 1 unit and bioanalytical lab translate to operational and communication efficiencies for you.

Contact us to learn more

Insights

hourglass suggesting NDA timeliness for early phase studies Case Study

Case Study: Proactive Strategies for Meeting NDA Timelines Despite Last-Minute Supplemental Study Requests

Video

Sink or Swim: Successfully Executing NDA-Enabling Studies to Avoid Rough Waters

AME studies whitepaper image White Paper

When the FDA Knocks Answer with AME Study Results for Clinical Trial Success

Our Dedicated Team

Lona Sheeran

Senior Vice President, Clinical Operations Early Phase

Hear from our past customers about their experience with Worldwide

“During the RFP process, Worldwide Clinical Trials was highly responsive, and their medical and scientific expertise in understanding the clinical trial was something from our end that was truly outstanding compared to other CROs that responded to us.”

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

“The proposal that Worldwide Clinical Trials gave us was the most insightful in terms of suggesting some specifics strategies that the others CROs didn’t include.”

Early Phase: Small Biopharma Customer Head of Regulatory Affairs

“They have the expertise in-house. They really blew it out of the park – during the bid defense, the ad hoc questions, and even in the one-hour session where they solidified their position as to why we should work with them. But I have to say that the major factor was the internal expertise. It was just terrific the amount of knowledge the team had in the indication and the connections they had.”

Early Phase Small Biotech Customer VP, Clinical Operations

Study consultation, execution, and quality data – delivered with the highest level of service and transparency.

Schedule a consultation with our team