• Overview

In clinical pharmacology research reviews, timing is everything

The clock is always ticking for clinical pharmacology research. WIRB's Clinical Pharmacology Unit Services division is set up to respond quickly for a fast and thorough review. We have vast expertise with clinical pharmacology research, including Phase I, bioequivalence/bioavailability, diabetes, oncology, and renal research in healthy and diseased subjects.

Streamlined process
With our clinical pharmacology review expertise, we have developed streamlined systems to meet almost any circumstance, while still placing the safety of our human subjects first.

Responsive boards
Our Board is structured to be highly responsive, anticipating adaptive study design and addressing changes related to the safety and efficacy of the research.

Site visits
During our pre-review site visits we gather all critical information and ensure your site meets all safety standards, guaranteeing a faster review turnaround.

Rapid turnaround
Our Board meets two times per week to provide accelerated turnaround times from completed submission to document delivery. From the time we receive your complete submission, our turnaround time is:
  • 5–7 working days for full board reviews.
  • 24–48 hours for items that can be reviewed through expedited.

Efficient communication
Your team will have a single point of contact who understands the unique needs of your organization, as well as time-saving online tools: All submissions and documentation are delivered electronically, and our secure portal, WIRB ConnexusTM (https://connexus.wirb.com), lets you submit and track your research review at any time.

Deep expertise with ethical compliance—worldwide
WIRB has a global network and decades of experience working around the world. In international reviews, our panel observes strict compliance with local and regional regulations, as well as cultural sensitivities, so you can be sure your study will pass the strictest scrutiny, anywhere in the world.

Dedicated subject-matter experts
Nationally and internationally, you will have a local coordinator who will provide guidance and represent you to the Board. Our local coordinators are authorities in process submission, and specially trained as subject matter experts (SMEs) in their area.

Education and consulting
WIRB's staff of experts and educators offers a wide array of education, consulting, and staffing services for investigators, local IRBs, and sponsors. WIRB can help you write your protocol or your consent form, and provide regulatory support for local IRBs. Learn more about our Education and Consulting Services.

Getting started
To prepare your submission, please review the relevant industry regulations, view WIRB's submission resources, or contact us with questions. When you are ready to submit, log on to WIRB ConnexusTM (https://connexus.wirb.com) at the top right of this page.



FREQUENTLY ASKED QUESTIONS
1
What is WIRB’s turnaround time?
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Does CPU Services review more than first-in-human, healthy subject protocols?
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What qualifications does my site need?
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How do I become a CPU Services client?
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What are the benefits of CPU services?