Clinical Research Consulting Services

Expert Support for Clinical Research and Research Administration

Planning and executing an ethical, feasible, and efficient clinical trial can be overwhelming, especially when incorporating real-world evidence and decentralized methods. Univo IRB’s clinical research consulting services help institutions, investigators, and research organizations navigate the complexities of clinical research and research administration.

Supported by extensive experience in research design and development, regulatory compliance, operational strategy, and workforce development, we partner with you to enhance the quality, integrity, and efficiency of your research program — because our goal is to protect your patients, not try your patience.

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STRATEGIC GUIDANCE

AUDITING AND COMPLIANCE

RESEARCH TRAINING & EDUCATION

RESEARCH STUDY DESIGN CONSULTING

TEMPORARY STAFFING SOLUTIONS

THE VOICE OF THE PATIENT

Clinical Research Consulting Services Built For You – Because One Size Doesn’t Fit All in Research

Our IRB consulting services are tailored to meet the needs of your organization, providing customized expert solutions to build, grow or maintain a compliant research program.

Strategic Guidance for Research Administration

We offer research administration consulting to optimize research infrastructure, streamline operations, and strengthen oversight. Our services include:

SOP development
Policy review

Workflow assessment
Sponsor and regulatory engagement guidance

Auditing & Compliance

Ensuring your research remains compliant is vital, and we are here to help.

Using our deep GCP, FDA, ICH, and institutional standards expertise, we conduct research compliance audits to assess regulatory compliance, identify risks, and recommend actionable improvements.

A bright, glass‑walled conference room: a smiling woman in a beige blazer stands at the head of a black table, gesturing as she leads a presentation displayed on a large monitor behind her. Three colleagues—a man in a gray sweater taking notes, a man in a white shirt listening thoughtfully, and a woman in a blue blouse seated at a laptop—sit around the table strewn with notebooks, a tablet, coffee cups, and glasses of water. Through the floor‑to‑ceiling windows, a parking lot and city buildings are visible.

Research Training & Education

We develop and deliver custom research training programs for research teams, administrators, and compliance staff. Topics include human subjects’ protection, GCP, study startup, protocol adherence, and research ethics. Whether virtual or in-person, we tailor sessions to your team’s experience level and institutional goals.

We also offer accredited and certified GCP and human research protection program (HRPP) training for research staff looking to supplement their current offerings. Our training modules are created by experts with real-world examples that will improve compliance and adherence to research policies and regulations.

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Temporary Clinical Research Staffing Solutions

Need experienced interim support? We provide vetted professionals for your local IRB and administrative operations roles such as budgets and contracting, filling short-term or project-based needs with experts that can start immediately and are already familiar with IRB systems and research administrative processes.

Research Study Design Consulting

Our clinical trial study design consulting is tailored to the specific needs and objectives of your trial, no matter the discipline, therapeutic area, region, or setting. Our services include:

Developing study protocols and informed consent documents
Evaluating the feasibility and validity of the study endpoints and outcomes
Considering alternative trial designs that go direct to the patient

Identifying and mitigating potential risks and biases in the study design
Guidance with ethical approval from the IRB
Determining appropriate patient recruitment campaigns and practices

The Voice of the Patient

Univo IRB is the only IRB focused on patient advocacy as a way to unify patients and research for the benefit of all. With strong partnerships in the patient advocate community, we help you recognize the full potential of your trial or research program with services including:

Patient insights for study design
Educational resources

Stakeholder engagement by bridging communication between patients and industry

Want to Hear the Voice of the Patient Firsthand?

With episodes featuring research professionals and patients sharing their real-world trial experience, the Unifying Research podcast is your bridge over the gap between the business and patient sides of the research industry.

LISTEN NOW

Who We Serve

Our clinical research consulting services are designed for a range of institutions and research organizations, including:

Academic medical centers
Clinical research sites and networks
Hospitals and healthcare systems

Nonprofit organizations
For-profit organizations conducting research

Why Partner With Us

Whether you need short-term support or long-term strategic advising, our clinical research consulting services provide:

Every offering is led by experts with backgrounds in clinical research, regulatory affairs, and academic research administration

There is no “one way to do research”; we appreciate your organization’s unique research program and adapt our services to meet your size, structure, and strategic goals

Our goal is to provide solutions that actually work within your organization; with experts that have proven track records of running successful research programs, we focus on lasting solutions, not superficial fixes

We promise a client-first approach with transparent communication and timely results

Partner With Univo IRB to Streamline Your Research Program

Are you ready for enhanced quality, integrity, and efficiency? Let’s get started.