|Our expansive service offerings are designed to improve, validate or facilitate the growth of the institutional research program. WCG Consulting services include:|
HRPP Compliance and Efficiency Assessment Interim IRB and HRPP Staffing and Management HRPP Transformation IRB Rescue and Transfer AAHRPP Accreditation Support Good Clinical Practice (GCP) and Compliance Services Investigation of Allegations of Noncompliance Clinical Research Startup Acceleration Research Protocol Design and Writing Biosafety Program Assessments Biosafety Program Management Biocontainment Laboratory Verification Biosafety Training
Rely on our unsurpassed experience as both the most productive and most trusted IRB in the world to drive increased efficiencies and compliance across your institution, with a unique approach led by experts who have a complete understanding of the clinical research enterprise in academic, private practice, and industry settings.
Gain immediate access to operational support and implementation when you need it most. We provide full and part-time support options for program staffing, as well as experienced management professionals to support an effective and efficient IRB.
Receive holistic advice from the only organization providing a full spectrum of services, ranging from eIRB information technology, to consulting and training, to back-office IRB support and fully-outsourced review. With deep AAHRPP accreditation experience and time-tested IRB business processes, we provide a unique combination of live didactic and online training, as well as on-site mentoring, to fully and completely transform your research program. Our clients run the most compliant, low cost, rapid turn-around and investigator-friendly programs in the industry.
We can assume temporary or permanent oversight of your organization’s research and facilitate the transfer of protocols from your local IRB. For organizations transferring research on a short-term basis, we build a regulatory, operational and knowledge infrastructure to ensure the viability of the local IRB moving forward. For organizations transferring research due to regulatory issues, we provide assistance in remediating and correcting regulatory findings and responding to federal agencies.
Trust the guidance of the only organization that has assisted over 180 organizations in achieving full AAHRPP accreditation. No one understands the accreditation process better than we do; our team is comprised of former AAHRPP standards developers, accreditors, site visitors, and council members. We help organizations to achieve accreditation/re-accreditation in a way that builds on their strengths and limits their focus to areas of meaningful improvement. With our extensive experience and familiarity with the AAHRPP accreditation process, we have helped clients to achieve full accreditation in less than 12 months.
Our consultants deliver global consultancy services for the development and implementation of Good Clinical Practice (GCP) and Human Research Protection (HRP) procedural standards and programs for the conduct of clinical research studies.
WCG consultants employ a collaborative approach to seamlessly correct mistakes, cure deficiencies, and implement programs to prevent recurrence. Our experts focus on gathering salient facts to reduce costs without compromising thoroughness.
Choose from custom “build-or-buy” acceleration options to fit or extend your organization’s resources and core competencies, while leveraging our network of sponsors and CROs seeking effective and efficient institutional sites.
Collaborate with our experts on the design of a study and its translation into an IRB-compliant, written research protocol. We focus on minimizing risks to subjects, improving the scientific design of the study, and ensuring that the recommended design answers the proposed research question. Our support includes guidance on consent writing.
Reviews for regulatory compliance and best practices, gap analyses and corrective action.
Temporary staffing and outsourced program management.
Initial or re-verification of BSL-2, 3 and 4 laboratories against CDC/NIH/USDA guidance, and support of lab design efforts.
Biosafety/Biosecurity, IBC and PI, Select Agents, Bloodborne Pathogens and customized topics.
HRPP Compliance and Efficiency Assessment
Interim IRB and HRPP Staffing and Management
IRB Rescue and Transfer
AAHRPP Accreditation Support
Good Clinical Practice (GCP) and Compliance Services
Investigation of Allegations of Noncompliance
Clinical Research Startup Acceleration
Research Protocol Design and Writing
Biosafety Program Assessments
Biosafety Program Management
Biocontainment Laboratory Verification