Ora’s Quality Compliance team has five full-time experts dedicated to clinical trial quality assurance.
Why is quality assurance important?
You need to know that your studies are being conducted to the highest standards. This is possible only through finely tuned Standard Operating Procedures (SOPs), laid out in accordance with current Good Clinical Practices (cGCPs), the FDA, and International Council for Harmonization (ICH) guidance requirements.
Ora’s Quality team is brought in on the ground floor to build a solid relationship with our clients, sites, and vendors.
What does the QA team do?
- Reviews and approves Investigational New Drug (IND) filings
- Works closely with clinical teams to ensure that all studies meet internal SOPs, cGCPs, and ICH guidance requirements
- Develops quality plans for studies that define site audits, data and document review
- Offers ETDRS BCVA and lane certification to all our sites
- Provides documented training programs for all site personnel
- This includes training of study personnel in on-site preparation of unusual formulations of drug products
- Reviews and approves the clinical supply and stability protocols
- Audits all 3rd party vendors, performing a thorough assessment of organizational structure, staff qualifications, and procedures
- This includes auditing manufacturing facilities for drug substance and drug product