Services

We perform discrete tasks or lead comprehensive programs for your regulatory, quality and clinical requirements. We collaborate with your team to troubleshoot and achieve cost-effective and time-efficient solutions.

Well-designed studies optimize outcomes.

We help our clients satisfy testing requirements for intended markets. We oversee both GLP and non-GLP animal studies for acute or chronic assessments as well as cadaver studies. We support study design and operations, managing first-in- human and early feasibility studies, pivotal trials for commercial approval and post-market registries.

Our pre-clinical services include:

  • Pre-clinical strategy
  • Laboratory/Facility selection and qualification
  • Laboratory/Facility audit
  • GLP and non-GLP testing
  • Acute/Chronic animal testing
  • Biocompatibility testing
  • Performance testing

  • Cadaver testing
  • Study Director oversight
  • Pre-clinical protocol and data collection forms
  • Pre-clinical report
  • Project management and study updates
  • Abstracts and articles for publication

Experien Group Clinical Services

Our clinical services include:

Gap assessment/inspection preparation support:
  • Clinical SOPs
  • Clinical audits of Sponsor or CRO
  • cGMP support
  • Bioresearch Monitoring (BIMO) inspections
  • Literature search
Site support
  • Identification/Selection
  • Qualification
  • IRB/EC submission
  • Initiation
  • Training
  • Investigator Agreements
  • Study budgets
  • Regulatory files
  • Interim monitoring
  • Closeout
Clinical documentation
  • Protocol
  • Informed Consent
  • Case Report Forms
  • Investigator Brochure
  • Clinical Report

Clinical operations
  • Essential documents/central study files
  • Monitoring plan/oversight
  • Study management
  • Manual of Operations
  • Reading center/core lab interface
  • Investigator meeting
  • Clinical Events Committee
  • Data Safety Monitoring Board
  • ClinicalTrials.gov reporting
  • SAE narratives/reporting
Study design/clinical synopsis
  • First-in-Human/feasibility study
  • Pivotal trial
  • Post-market study/registry
Clinical strategy
  • Clinical readiness of product
  • U.S. and/or OUS studies
  • FDA Early Feasibility IDE opportunity
  • ClinicalTrials.gov research

We need people who can become a part of the company in order to guide us through commercialization

Client quote