PPD Functional Service Partnership (FSP) Quality Assurance (QA) Solutions

Discover the right solution to ensure the safety of your clinical trial

It is imperative for biotech, biopharmaceutical and medical device organizations to ensure the safety and integrity of their clinical trials so they meet ethical, regulatory and legal requirements and protect the rights and welfare of study participants.

PPDTM Functional Service Partnership (FSP) Quality Assurance solutions help ensure the integrity of your clinical trial programs by providing the strategic and operational expertise you need. Our quality assurance (QA) experts help you navigate the nuances of country-specific rules and regulations, mitigate risks, drive compliance and, most importantly, protect patients.

PPD FSP QA solutions also draw from the people and best practices of a proven quality management system (QMS) to deliver solutions tailored to your unique needs. Whether you need specialized functional support or highly skilled staff to complement your existing capabilities, our bespoke solutions provide much needed resource flexibility, reliability and continuity to meet your timelines and ensure the integrity of your study.

Our quality assurance capabilities, by the numbers

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Over 30 years of QA experience

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More than 2,500 contracted audits across nearly 70 countries


Approximately 400 clinical supplies QA awards for almost 200 customers

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More than 600 good practice (GxP) quality experts in every region around the world

Comprehensive QA solutions to protect the integrity of your study

With a proven track record of delivering comprehensive QA solutions, we ensure the reliability and integrity of your clinical trials. Our breadth and depth of strategic and operational expertise keep your studies on schedule by rigorously assessing your clinical trial programs and systems to ensure they meet ethical, regulatory and legal requirements and protect the rights, safety and welfare of your study participants.

Download the FSP quality assurance solutions brochure

Our FSP QA solutions include:

Study-specific quality support Act as a dedicated QA point of contact to assist customer and study teams with all quality aspects of the trial.
Supply chain quality management Support oversight of product manufacturing, clinical packaging and labeling, and distribution to clinical investigator sites, including quality agreement development, mock recalls and product release by QPs (all investigational product types, including cell and gene therapies).
Government consulting Provide QA services specific to the requirements of government-funded studies.
Information systems quality assurance consulting Provide consultancy and training for validation and data integrity.
Inspection readiness Support the preparation, hosting, response management and follow-up of inspections of regulated operations.
Auditing Provide audits of regulated operations to support clinical trial submissions, including:
  • Clinical investigator sites
  • Processes
  • Vendors
  • Files
  • Databases
  • Pharmacovigilance
  • Computer systems and validation
  • Electronic records and signatures
  • Data integrity
  • Suspected misconduct
  • Qualified person (QP) audits of the supply chain

Leverage local knowledge and global expertise to mitigate risk, drive compliance and protect patients

For each engagement, our FSP QA solutions employ dedicated teams of quality assurance experts located across the world. With a customer-first problem-solving mindset, extensive risk assessment skills, and local experience and expertise, our team members provide in-depth knowledge and know-how of their home country’s rules and regulations to help you better navigate the nuances of local regulatory requirements, mitigate risks, drive compliance and protect patients.

Our teams adhere to tight timelines and collaborate with cross-functional subject matter experts (SMEs) to deliver detailed reports enabling well-informed and swift decision-making. Our ability to rapidly mobilize teams globally allows us to quickly provide on-site assistance with:

  • Hosting and facilitating inspections
  • Preparing, collating and tracking documents
  • Assessing internal audit findings and routine file review results
  • Providing debriefs and summaries
  • Responding to findings and ensuring actions are completed
  • Conducting lesson learned assessments

For each engagement, we equip all our QA team members across countries with consistent training and standard operating procedures (SOPs). As a result, they support a wide range of QA needs and hit the ground running. With a keen understanding of what’s required for study execution and performance, our QA team members review the intricate details to ensure no small detail is overlooked. Staff are also required to participate in regular reviews of training needs, undergo semi-annual performance reviews and complete role-specific trainings within the learning management system (LMS) that are verified through gap analyses to ensure compliance.

And because the foundation of every solution we provide is a culture of training, accountability and recognition, our teams drive adherence to the highest standards by embracing techniques from industry-standard quality programs (Six Sigma, Lean Sigma, Total Quality Management, and ISO 9001). Through this approach, we provide the top-tier expertise you need to drive protocol and regulatory compliance, identify and mitigate risks, verify the reliability and integrity of your data and protect the rights and welfare of your patients.

Bespoke solutions tailored to your unique needs

With our extensive QA expertise, our teams quickly identify the best engagement model for your needs. Using best practices and lessons learned from our decades of experience, our QA solutions support a customizable mix of systems, processes and oversight. We provide the flexibility to either embed staff within your workforce using your existing infrastructure, SOPs and processes – or take the business fully in house using our SOPs, processes and systems.

In addition, our innovative pricing models also accommodate various contract structures – from full-time equivalent, unit-based, time & materials and hybrid models. These flexible models can be tailored to evolve over time with your changing needs.

No matter the level of engagement you choose, our QA solutions draw from a proven quality management system that helps keep your clinical trial in compliance with all applicable laws, regulations and institutional policies. Through the systematic use of well-established best practices, quality policies, manuals, procedural documents, the consistent application of key performance indicators, key quality indicators, data analytics, audit and quality event outcomes, corrective and preventive actions, and executive management review, our solutions deliver the QA expertise you need to ensure the reliability and integrity of your study.

Contact us

Let us help you ensure the reliability and integrity of your study. Connect with PPD FSP Quality Assurance solutions to leverage the strategic and operational expertise you need to navigate country-specific rules and regulations and keep your studies on schedule.