With proven expertise in GCP, GLP, GMP, and GVP compliance, you can trust Advarra Consulting to provide practical assessments and advice for any aspect of study conduct.

Experienced Project Managers

Each client works with a senior-level staff member responsible for quality oversight of services, deliverables, and communications.

Proven Methodologies

Advarra brings hard-earned insight and knowledge to your research practice and programs, customizing each solution to specific client needs.

Global Capabilities

From clinical sites to laboratories to data review and vendors, Advarra can review and provide recommendations for every touchpoint in your programs.

Independent, Preventative, and Proactive Quality Assurance

Advarra Consulting provides flexible services and approaches to assist clients in implementing GxP quality strategies that support compliance and minimize regulatory risk while protecting the safety and welfare of clinical trial participants. Our collaborative approach allows us to provide appropriate and customized clinical trial auditing support and assistance in developing clinical quality assurance (CQA) programs and infrastructure.

We assist clients with procedures for regulatory compliance using our extensive knowledge of industry best practices while also considering practical logistics, business efficiencies, and common sense. We emphasize proper quality control with appropriate documentation throughout all clinical trial processes leading to a regulatory submission.

Experienced GxP Experts

Advarra Consulting’s GxP Services Group boasts exceptional knowledge and experience, led by a large full-time team of highly experienced quality assurance (QA) professionals with diverse skills and expertise in GCP, GLP, GMP, GVP, and many supporting areas.

Our team provides services to a wide variety of clients, from small startup firms to fully integrated global pharmaceutical, medical device, and biotech firms, as well as institutions and government agencies. We serve clients in more than 60 countries, and our team members are fluent in over 30 languages.

Clinical Trial Audit Support

Advarra Consulting offers global GCP services that complement typical clinical trial auditing, including:

GCP Audits & Assessments

  • Clinical investigator site audits
  • Vendor audits
    • CROs
    • Laboratories (clinical, bioanalytical, and non-clinical)
    • IRBs/IECs
    • Phase I units
    • eSystem providers (IVR, EDC, eDiary, CTMS, EDMS)
    • Central readers
    • GMP (manufacturing, packaging, and distribution)
  • Clinical process audits (at sponsors/institutions)
    • Quality management systems
    • Organizational/functional process audits/assessments (e.g., medical writing, medical monitoring, data management, biostatistics, regulatory affairs, regulatory submissions, etc.)
    • Trial master file inventory and management (electronic and paper)
  • Data and document audits (e.g., IB, CSR, submission documents, database audits, etc.)

Assessments and Written Standards Development

  • Process assessment (process mapping)
  • Gap analysis (written standards)
  • SOPs/policies development
  • SOP administration and system development

Training

  • GCP, GLP, GVP, and device
    • Investigators and coordinators
    • Clinical research associates
    • Sponsors
  • Qualification, oversight, and management of clinical vendors
  • Regulatory inspection preparedness

Regulatory Inspection Support

  • Mock GCP regulatory inspections
  • Investigative site training and preparedness
  • Sponsor/CRO training and preparedness
  • Inspection support and facilitation (during/response)

Specialized Consultancy

  • Virtual clinical QA support
  • Safety surveillance and pharmacovigilance
    • Short-term safety staff support
  • Clinical vendor monitoring
    • IVR systems
    • Imaging
    • Central laboratories
    • Specialized laboratories
    • Central readers
  • Mid-study outsourcing and transition strategy support
  • Configuration of electronic documents for filing
  • “Lesson-learned” facilitation
  • “Swat” team clinical data review and cleanup
  • Government-funded research

Strategic Consulting

  • Development of clinical trial plans
  • Clinical trial program support
  • Strategy and document management of the trial master file
  • Clinical quality program development
  • Regulatory submission components
  • Ad-hoc consultancy

Good Pharmacovigilance Practices (GVP) Auditing and Consulting

Advarra Consulting has demonstrated expertise and knowledge to provide specialized consultancy and evaluation services focused on good pharmacovigilance (PV) practices for regulatory compliance. Advarra’s PV services encompass both clinical R&D safety surveillance and post-marketing PV across numerous therapeutic areas.

  • PV compliance audits (FDA, EMA, MHRA, Health Canada, other local country regulations)
  • Sponsor safety surveillance and PV internal process/systems assessments
  • REMS audits – specialty pharmacies, distribution centers, registry studies
  • Local affiliate/licensing partner PV audits
  • PV vendor audits – call centers, safety database vendors
  • PV regulatory authority inspection planning, preparation, and support
  • PV CAPA development advisory services and support
  • PV strategic and risk management ad-hoc consulting

Ready for Solutions That Are Altogether Better?

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