Quality Assurance Services

Theradex is committed to delivering quality, regulatory compliant clinical research services in a professional, efficient, timely, and cost-effective manner while protecting patient safety and data integrity for regulatory submissions. We do this using a risk-based Quality Management System (QMS) designed to meet applicable global regulatory, business, technical, and organizational requirements, as well as industry standards.

Theradex’s QMS is documented in a formal Quality Policy signed by the senior management, managed by an independent QA function reporting directly to the senior management, and includes the following:

  • QA responsibility for overall regulatory compliance.
  • Regular internal QA audits based on risk.
  • Documented control with QA oversight and approval for SOPs and Training for all operational areas.
  • 21 CFR Part 11 compliance for applicable computer systems and IT infrastructure including risk-based Validation according to a controlled SDLC.
  • Procedurally defined CAPA process to ensure issues are identified, analyzed, resolved, tracked, and closed out, while lessons learned are used for continuous improvement.
  • Documented Business Continuity and Disaster Recovery plans.
  • Regular QA updates to executive management to ensure visibility and resolution of issues.
  • Communication with clients and vendors regarding compliance and quality issues as needed.

The Theradex QMS takes into account global regulations and guidelines governing human clinical trials and the distribution of Investigational Products (IPs) to clinical trial sites. These include the FDA regulations as described within 21 CFR Parts 11, 50, 54, 56, 210, 211, 312, 314, 600 and 820; FDA Guidance on 21 CFR part 11 Scope and Application; ICH Tripartite Guideline for Good Clinical Practice, in particular Efficacy (E6), Declaration of Helsinki, EU Clinical Trial Directive, EU GCP Directive relating to medicinal products for human use, as well as various pharmacopeial requirements and industry standards (i.e., best practices). Implementation of Theradex quality principles through Standard Operating Procedures (SOPs) ensures that all services and products meet the applicable requirements (clinician, patient, pharmacist, health authorities, etc.) for quality, safety, identity, uniformity, and reliability.

Theradex quality is mandated and supported by Senior Management and is coordinated by Quality Assurance, however, quality is the responsibility of all Theradex employees. It is monitored by departmental self-audits, internal QA audits, overall facility audits that may be commissioned by either QA or Senior Management utilizing outside expert contractors and consultants within the QA field, and quality is enforced by regulatory agency inspections and investigations.