Research Consulting Services, Simplified

Strategic Guidance For Research Administration & Oversight

We offer consulting services to optimize infrastructure, streamline operations, and strengthen governance – for clinical trial sites and academic research programs alike. Our expertise spans:

• Research Administration 
• Research Operations
• Human Research Protections
• Animal Care and Use
• Biosafety
• Data Safety Monitoring

Within these areas, our services include:

• SOP development
• Policy review
• Workflow assessment
• Sponsor and funder engagement guidance
• Current-state program evaluation with a prioritized roadmap for improvement
• Accreditation preparation and maintenance

Committee & Board Support (IRB, IACUC, IBC, DSMB)

Human research protections is only one part of the oversight picture. Univo helps institutions establish, strengthen, and manage the full range of committees and boards that help keep research ethical, safe, and compliant:

• IRB (Institutional Review Board) – SOP development, member training, workflow optimization, protocol review support, and AAHRPP accreditation support
  
• IACUC (Institutional Animal Care and Use Committee) – protocol review processes, SOP development, inspection readiness, and AAALAC accreditation support
  
• IBC (Institutional Biosafety Committee) – biosafety protocol review, recombinant DNA and biohazard oversight, and NIH Guidelines compliance
  
• DSMB (Data Safety Monitoring Board) – charter development, independent monitoring plan design, and support convening and running boards for ongoing trials and studies

Whether you’re launching a new committee, revitalizing an existing one, or preparing for accreditation or inspection, our experts help you build oversight structures that are both compliant and workable for your team.

Auditing & Compliance

Ensuring your research remains compliant is vital, and we are here to help. Using our deep expertise in OHRP, FDA, ICH GCP, AAHRPP, AAALAC, and institutional standards, we conduct research compliance audits to assess regulatory compliance, identify risks, and recommend actionable improvements – including accreditation and inspection readiness for institutions preparing for an AAHRPP site visit or an FDA or OHRP inspection.

Research Training & Education

We develop and deliver custom research training for research teams, administrators, and compliance staff. Topics include human research protections, IRB, IACUC, Biosafety, and Data Safety Monitoring training, accreditation preparation, research administration, and research ethics. Whether virtual or in-person, we tailor sessions to your team’s experience level and institutional goals.

We also offer TransCelerate-recognized GCP training, which includes ICH E6(R3) and Annex 2, for sponsors, CROs, clinical research sites, and research institutions. Organizations can license the training for their teams, either as a SCORM package for their own LMS or through Univo’s platform, and individuals can enroll directly. Our training is developed by experts, built around real-world examples, and designed to strengthen compliance with research policies and regulations.

Research Staffing Solutions

Need experienced interim or long-term support? We offer flexible engagements – from a few months to several years – across roles ranging from front-line staff to program leadership in IRB, research administration, and research operations. Our vetted professionals are ready to step in immediately to support your program with minimal need for onboarding due to years of experience in the field and familiarity with most electronic systems.

For needs that outlast a typical interim placement, we can embed one of our specialists directly within your team on a long-term basis. Rather than filling a gap from the outside, this person works as part of your organization day to day – giving your program consistent expertise and support without the lead time or overhead of a traditional hire.

Research Study Design Consulting

Our research study design consulting is tailored to the specific needs and objectives of your research, no matter the discipline, therapeutic area, or setting – whether you’re designing a multi-site clinical trial or an investigator-initiated academic study. Our services include:

• Developing study protocols and informed consent documents
• Developing Data Safety Monitoring plans
• Reviewing study protocols, consent documents, and other study materials in advance of submission to an IRB, IACUC, or IBC

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: 

• Stakeholder engagement by bridging communication between patients and industry
• Patient insights for study design
• Educational resources