Comprehensive Capabilities

Meeting the expectation of a sponsor or regulatory agency are not black and white.  There are many factors that come into play and must be considered to determine the level of exposure and compliance problems your organization is facing.  We offer a full portfolio of capabilities:
  • Sponsor / Agency Related Services - document preparation and reviews, a variety of audits (pre-sponsor / regulatory inspection, document, process, database, systems and vendor), compliance problem resolution (response development and help clients' remediate compliance issues and prevent recurrence), and/or special services specific to our clients' needs
  • Quality Assurance and Controls - evaluate standard operating procedures, help interpret regulations, build sample plans, oversight program review (governance practices - quality/compliance functions, internal audits with performance metrics) management controls and organizational structure (reporting relationships, staffing and competence, and communication systems)
  • System and Process Validation - evaluate for applicability of 21 CFR Part 11, application / computer system validation, and electronic medical records installation and qualification 
  • Tools Development - customized tools development
  • Due Diligence Audits - evaluate outsourcing agreements to ensure compliance with sponsor sub-contracting requirements
  • Training - customized training programs to ensure regulatory requirements and expectations for Good Clinical Practices, and provide formal policy updates