Our comprehensive service offerings are designed to improve the design and conduct of clinical research; accelerate study start-up; reduce the risks inherent in conducting a clinical trial; and validate or facilitate human research protection initiatives for sponsors and contract research organizations (CROs). WCG Consulting services include:
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.
Consultation on Policy Development
Consultation and preparation of policies related to human subject protection including subject compensation, payment for study co-medications, reporting study results to subjects.
Consultation on Bioethics
Expert advice in the increasingly challenging area of ethical considerations in clinical research.
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.
Research Protocol and Informed Consent Writing
Expert guidance regarding study design and its translation into an IRB-compliant, written research protocol.
Draft Protocol Review
Review of draft clinical research protocols for compliance with regulatory and ethical best practices for human subject protection and clinical research conduct.
Investigations of Allegations of Noncompliance
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.
Clinical Research Start-up Acceleration
Creation of systems to facilitate and streamline the start-up of new research studies.
Clinical Research Risk Reduction
Creation of systems to reduce regulatory, legal, and ethical risks inherent within a study.
Data Transparency and Data Request Review Administration
Creation and administration of a system for the submission, review and processing of patient-level data requests.
Reviews for regulatory compliance and best practices, gap analyses and corrective action.
Biosafety Program Management
Temporary staffing and outsourced program management.
Biocontainment Laboratory Verification
Initial or re-verification of BSL-2, 3 and 4 laboratories against CDC/NIH/USDA guidance, and support of lab design efforts.
Biosafety/Biosecutiry, IBC and PI, Select Agents, Bloodborne Pathogens and customized topics.