Clinical Quality Assurance Services

ProPharma offers global Clinical Quality Assurance consulting to ensure inspection readiness and regulatory compliance across pharmaceutical, biologics, and medical device sectors. Our experienced QA professionals deliver end-to-end support—from GCP audits, SOP development, and CAPA management to trial oversight and mock inspections—tailored to your needs in every region. Wherever your clinical programs operate, we help you maintain quality, integrity, and confidence.

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Clinical Quality Assurance

A strong Clinical Quality Assurance (CQA) framework is essential for maintaining the integrity, reliability, and compliance of clinical programs. Our CQA services provide proactive to reactive quality support to sponsors and CROs, ensuring adherence to regulatory standards and industry best practices. Ensure Clinical Quality & Compliance with Expert Support.

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Our Clinical Quality Assurance Solutions

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Vendor Management & Compliance

Oversight and compliance support for CROs, investigator sites, central labs, pharmacies, animal/toxicology studies, SaaS providers, and other vendors to ensure regulatory adherence and performance.

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Clinical Investigation & Remediation

Identifying and resolving clinical trial issues to mitigate risks and improve study outcomes.

Compliance

TMF/eTMF Compliance Reviews

Thorough assessments of Trial Master Files to ensure completeness, accuracy, and regulatory compliance.

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Ad-Hoc Clinical Quality Consulting

Tailored support to address specific clinical quality challenges and operational needs.

Comprehensive Clinical Auditing Services

A structured auditing approach is essential for identifying compliance gaps, mitigating risks, and ensuring regulatory readiness. Our clinical auditing services help organizations maintain compliance with global regulatory expectations.

Our Clinical Auditing Solutions

  • Compliance Audits – Conducting audits across GCP, GCLP, GLP, non-GCP, PV, and REMS to ensure adherence to clinical and laboratory standards.
  • Gap Assessments & Mock Inspections – Identifying potential compliance risks and preparing teams for regulatory scrutiny.
  • For-Cause & Due Diligence Audits – Investigating compliance concerns and evaluating potential risks before regulatory action.
  • Vendor & Site Qualification Audits – Assessing CROs, investigators, and sites to ensure they meet regulatory and operational requirements.
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Clinical Inspection Readiness

Regulatory inspections can be complex and high-stakes. Our inspection readiness services ensure your organization is fully prepared to meet global regulatory expectations with confidence.

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Our Inspection Readiness Solutions

  • Clinical Study Gap Assessment – Identifying and addressing compliance gaps in clinical trials to mitigate regulatory risks.
  • Remediation & Documentation Support – Expert guidance on remediation strategies, including storyboarding, EDC, DMF, SOP development, and CAPA implementation.
  • Inspection Readiness Training – Customized training on regulatory expectations, sponsor responsibilities, and ICH E6 compliance to ensure teams are well-prepared.
  • Mock Regulatory Inspections – Conducting simulated health authority inspections to evaluate and enhance clinical trial readiness.
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Clinical Sponsor-Level QMS Support

A well-structured Clinical Sponsor Quality Management System (QMS) is essential for regulatory compliance, operational efficiency, and risk mitigation. At ProPharma, we help sponsors design, implement, and optimize QMS frameworks tailored to their clinical study and organizational needs.

Quality Management System Project Methodology

Preparation

The process begins with a kick-off meeting to ensure alignment with our client and key stakeholders to review unique requirements to consider.

  • The client shares their current business model and organizational objectives.
  • ProPharma reviews the Statement of Work (SOW) to confirm scope and deliverables.
  • Roles, responsibilities, and a communication plan are clearly defined to guide the engagement.

Execution

Moving into the execution phase, we assess and implement QMS improvements:

  • A QMS assessment audit may be recommended to evaluate the current state and identify gaps in compliance.
  • A prioritized GxP documentation implementation plan is developed based on audit findings.
  • Quality system documents are revised or created to address identified needs.
  • Collaborative review sessions and stakeholder interviews are conducted to ensure alignment.
  • Implementation support, including the development of training materials and related documents, is provided as needed.
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Our Clinical QMS Consulting Services Include

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QMS Assessment & Right-Sizing

Evaluating your current QMS and scaling solutions to fit your organization’s size, scope, and regulatory requirements.

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Policy & Procedure Development

Creating and refining policies, SOPs, and quality documents to ensure compliance with industry standards.

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End-to-End QMS Implementation

Supporting the seamless integration of quality management systems across your operations.

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QMS Training & Compliance Readiness

Providing in-depth training on QMS best practices, regulatory expectations, and continuous improvement strategies.

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Optimize Your QMS with Expert Support

Whether you're building a new QMS or enhancing an existing system, our experts provide tailored solutions to ensure compliance and efficiency.

Medical Device Clinical Quality Support

At ProPharma, we provide expert clinical consulting services to medical device and diagnostics companies. Helping to navigate and ensure compliance to complex global regulatory requirements while achieving operational excellence.

Regulatory & Quality Support for Medical Devices

Our team specializes in supporting the unique requirements of medical device companies in meeting international compliance standards, including:

  • Design Control Requirements – Ensuring clinical trial and study activities align with international regulations for product design and development.
  • Clinical Trial File Management – Expert guidance in maintaining regulatory-compliant trial master files.
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Contact Our Clinical Quality Assurance Team

Partner with us for expert clinical compliance and quality solutions. Contact ProPharma today to learn how we can support your organization’s Clinical Quality Assurance needs.

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ProPharma Appoints Brian Tuttle as Chief Financial Officer

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ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

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ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

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ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

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