Quality Assurance

Ora’s dedicated Quality Assurance team provides independent oversight and auditing to ensure the data integrity of every clinical study.

Why is Quality Assurance Important?

When it comes to clinical development, you want the confidence that your studies are being conducted to the highest standards. At Ora, we operate with finely tuned Standard Operating Procedures (SOPs), laid out in accordance with current Good Clinical Practices (GCPs) – all adhering to FDA and International Council for Harmonization (ICH) requirements. Our Quality team is involved in every project and has solid relationships with our clients, sites, and vendors.

Our QA Services

  • Work closely with clinical teams to ensure that all studies meet internal SOPs, GCPs, and ICH guidance requirements
  • Develop quality plans for studies that define site audits, data, and document review
  • Offer ETDRS BCVA and lane certification to all our sites
  • Provide documented training programs for all site personnel
  • Train study personnel in on-site preparation of unusual formulations of drug products
  • Review and approve clinical supply and stability protocols
  • Review and approve Investigational New Drug (IND) filings
  • Audit all third-party vendors, performing a thorough assessment of organizational structure, staff qualifications, and procedures
  • Audit manufacturing facilities for drug substance and drug product