Clinical Operations Excellence
At Nopras, our Clinical Quality Policy is to provide superior service to our clients while building exceptional service relationships.
Our clinical quality management processes are integral to all aspects of our business. Our consultants perform regular quality assessments of our client services to ensure compliance with FDA (21 CFR 312) and international GCP regulations, ICH, ISO, and SOPs.
Nopras’ former FDA Medical Reviewers apply comprehensive “FDA” style review of safety and efficacy data, thereby providing a peace of mind for our clients.
We operate a robust vendor qualification process and regularly administer vendor audits through a variety of mechanisms to ensure all our clients meet or exceed our stringent standards.
In fact, Nopras’ commitment to quality facilitated our North American headquarters to earn ISO 9001:2008 certification . Today each Nopras location operates under our centralized quality
Furthermore, we have maintained ISO certification through successful biennial re-registration audits. Our clients benefit from this in the following ways:
- Regulatory Compliance to ensure data integrity and human subject protection.
- Strategic planning of clinical development programs.
- Clinical trial design and protocol development.
- Set up and management of early phase studies.
- Comprehensive review of safety and efficiency data by former FDA Medical Reviewers.
- Due diligence and second person review of development plans/protocols.
- Personalized service from experience team members.
- Flexible and responsive.
- Time and budget sensitive
- Clinical development consultants with FDA and clinical development experience.
- Clinical trial specialists with extensive industry experience in all aspects of study set-up and management.
- Experience GCP Auditors.
- Gap Analysis and Due Diligence.
- Clinical Development Plans (CDP) and Strategy Design.
- On-going Clinical and Regulatory Input for Clinical Programs.
- Represent Sponsor to FDA.
- FDA Documents Review Prior to Submission.
- Clinical Studies Design.
- Provide support for clinical component of regulatory submissions.
Clinical Quality Assurance
- Vendor qualifications of CROs, SMOs, Clinical and Core Laboratories, Contract Manufacturers, Biostatistics and Data Management.
- Site qualification and initiation visits.
- GCP training at clinical sites and investigator’s meetings.
- Preparation of Audit Schedules, Audit Plans and SOPs.
- In-study Quality Assurance Audit of Clinical Sites, Vendors, Monitors, Databases and Trial Master Files (TMF).
- “For-cause” audits of suspected research.
- Closing out clinical sites.
- Preparation for regulatory audits by former FDA field investigators.
- Request for Proposal (RFP) preparation.
- Site Identification, Pre-Qualification and Site Qualification Visit (SQV).
- IRB Submission preparation.
- Investigator Meetings Coordination.
- Site Initiation Visit (SIV).