Spotlight on Data and Quality

Interview with Harry Thomas:
Data Quality Assurance Officer

An introduction to Harry

Harry, tell us a bit about yourself?
I joined Purdie Pascoe in November 2024, following a career as a data compliance specialist in the clinical research industry and with a degree in History. Both paths have sharpened my eye for detail and nurtured a genuine curiosity for uncovering patterns and inconsistencies. I’ve always enjoyed the challenge of spotting what others might miss, so when the chance came to turn that into a full-time role here, it felt like the perfect fit.

Outside of work, what do you enjoy doing?
I’m an absolute sports nerd, and over the past couple of years I’ve been fortunate enough to provide regular commentary for my beloved Tranmere Rovers. When I’m not watching fourth-division football (and loving every minute of it), you’ll usually find me out on a long walk with my girlfriend and our dog, my favourite way to unwind and reset.

If you could have one superpower, what would it be, and why?
It’s an obvious answer but I’d love to be able to teleport! The idea of popping halfway around the world for the weekend or spending my lunch break exploring a new city every day, sounds like the ultimate dream. No airports, no traffic, just instant adventure!


Harry’s Perspective - Deep Dive

Can you briefly tell us about your role as Data Quality Assurance Officer at Purdie Pascoe?
I provide quality control and assurance across all stages of the project lifecycle at Purdie Pascoe, offering an impartial and detail-focused perspective on data and project materials. We’ve all experienced that moment when, after hours immersed in a report, a fresh pair of eyes spots something obvious that was missed, that’s exactly the role I play.

My involvement begins at the questionnaire design stage. Beyond checking spelling, grammar, and programming logic, I work closely with the project team to ensure the questionnaire is set up to collect high-quality data. This means asking: Are our questions getting to the heart of the necessary endpoints for regulatory compliance? Are there any loopholes that might prevent respondents from providing appropriate responses to all questions?

Once a survey goes live, I provide regular, in-depth data checks to ensure that the data we are receiving is of a suitably high quality to comply with the client’s requirements. This includes, but is not limited to, ensuring once again that the data we are collecting is complete, that the respondents demonstrate sufficient expertise and knowledge of the device in question, and this also gives us an opportunity to ensure that our questionnaire is functioning as intended.

As the project moves into reporting, I conduct a final quality control review of all deliverables, checking for accuracy, clarity, consistency, and completeness of endpoint reporting. At every stage, my role adds an extra layer of protection and support, helping the team deliver data and insights that clients can trust.

You predominantly work within the Post Market Clinical Follow-Up (PMCF) Survey team, how do you support this service offering?
With PMCF (Post-Market Clinical Follow-up) being essential for medical devices to retain certification under EU MDR 2017/745, the quality of data collected through PMCF surveys is absolutely critical. Each survey is designed with highly specific and nuanced criteria, tailored to the unique requirements of the device in question. That’s why our PMCF team is deeply committed to ensuring that every survey is precisely aligned with regulatory expectations.

To uphold this standard, we implement rigorous quality checks at every stage of the project. My role in quality control plays a key part in this process, helping to identify and resolve any issues in real time that could compromise data integrity. This layered approach ensures that the data we deliver supports our clients in confidently achieving and maintaining their EU MDR certification.


How do you define ‘data quality’ in the context of PMCF?
Within PMCF, respondents must meet strict, and often complex, screening criteria to qualify. This makes it essential that the data collected is accurate, complete, reliable, and fit for the purpose of supporting EU MDR 2017/745 device certification. That commitment to quality begins at the very start of the process: with the questionnaire design. High-quality data can only be gathered if the right tools are in place, and our PMCF team excels at crafting specialised, well-structured questionnaires that enable qualified respondents to provide the insights we need.

Once data collection is underway, our rigorous quality control processes allow us to examine every response in detail. We look for anomalies or inconsistencies that could compromise the validity of a respondent’s input. Whether we have 2 or 200 completions, each dataset undergoes the same thorough review, ensuring that every datapoint included in the final report can be confidently defended.

Medical devices are held to exceptionally high regulatory standards, and we treat the data that supports them with the same level of scrutiny and care.

How do you handle discrepancies or anomalies in collected data?
As part of our rigorous approach to data quality, we conduct soft launch reviews—deploying the survey to a small group of respondents to collect an initial batch of data. This allows us to confirm that the study is functioning as intended, make any necessary adjustments, and anticipate trends or potential “pain points” before the full launch.

Once we’re confident that the questionnaire is performing as expected, the survey is fully launched. From that point on, we carry out regular data checks to ensure that no discrepancies or anomalies go unnoticed. At Purdie Pascoe, quality control is a team effort. In addition to my own reviews, we embed validation rules into every survey, and all data passes through multiple layers of checks before being approved.

When I identify a potential issue, I always begin by discussing it with the project team. Collaboration is a vital part of our process; it helps us determine whether a discrepancy is due to poor-quality responses or simply reflects unexpected but valid respondent behaviour. After all, data doesn’t always behave the way you expect it to, but that doesn’t necessarily mean it’s bad.

We also maintain open communication with clients and, when appropriate, follow up with respondents to clarify unclear answers. However, when we do identify bad or fraudulent data, we take a zero-tolerance approach: those responses are removed from the study. If a programming or validation error is discovered, it’s addressed promptly by the project team and survey programmers to ensure it doesn’t impact the integrity of the results.

What methods do you use to ensure the accuracy and completeness of survey responses?
As mentioned above, we implement robust survey validation rules to ensure that all responses are complete, followed by multiple rounds of data checks to confirm that the data collected is both accurate and appropriate. In cases where logic cannot be fully programmed into the survey, we carry out manual checks to flag potential issues and take the necessary action.

For example, we may follow up with a respondent who reports using a dental membrane in a pericardiectomy or question a physician at a children’s hospital who reports multiple cases involving geriatric patients. These kinds of inconsistencies are carefully reviewed to ensure data integrity.

We also incorporate open-ended questions to give genuine respondents the opportunity to elaborate on their use of a device, while also helping to expose poor-quality or fraudulent responses. In addition, we monitor for red flags such as speeding through the survey, flatlining (providing the same answer repeatedly), and other suspicious response patterns.

How do you adapt your QA processes when working with new or evolving data collection technologies?
Within PMCF, our quality assurance processes are designed to uphold the integrity, reliability, and regulatory compliance of the data we collect. Given the structured requirements and stringent criteria involved, it’s not always feasible to adopt the latest data collection technologies commonly used in broader market research. However, due to the clinical nature and data security demands of our studies, we’ve worked hard to ensure that our data collection platform meets all necessary standards, while continuing to evolve into a best-in-class solution for our clients’ PMCF needs.

Any updates to our platform are carefully reviewed to ensure alignment with EU MDR requirements and remain consistent with ISO 14155 standards. At the same time, we stay alert to changes in the wider data landscape, particularly emerging trends such as the rise of AI-generated survey responses. Our quality assurance approach is continuously adapted to reflect these developments. We proactively monitor for inconsistencies, unusual patterns, or signs of artificial input, and update our internal processes accordingly. The wider team is also trained to identify and address these issues, ensuring that our data remains trustworthy and defensible.

How do you ensure compliance with data privacy and ethical standards?
Throughout our PMCF activities, compliance with data privacy and ethical standards is embedded at every stage of the process. We operate within the frameworks of key regulations such as GDPR, EU MDR, and ISO 14155, ensuring that all data is processed lawfully, transparently, and in line with the highest industry standards. These principles are also reflected in our internal quality assurance processes.

Adherence to these regulations is a core focus of my role. Across the entire project lifecycle, we follow strict internal policies and SOPs to protect both respondent and client data. As a company, we also complete annual training on ethical practices in the research industry, reinforcing our shared commitment to responsible data handling.

In my role as Data Quality Control Officer, I ensure that all questionnaires meet data privacy requirements, for example, by including the correct consent questions and accounting for market-specific considerations, such as Sunshine reporting in U.S. studies. On a data level, I review open-ended responses for any breaches of privacy, such as unprompted disclosures of personal information or ethically sensitive content. Once a project reaches the reporting stage, I ensure that all data is appropriately anonymised before being shared with clients.

Looking ahead to the second half of 2025, I’ll also be implementing a formal internal audit process at Purdie Pascoe. This will further strengthen our ability to maintain compliance with data privacy and ethical standards, and ensure we continue to meet the evolving expectations of regulators and clients alike.

How do you balance the need for fast turnaround with the need for thorough data quality checks?
At Purdie Pascoe, our PMCF team understands that timely delivery is critical, especially when supporting regulatory submissions or addressing safety concerns during a study. However, speed can never come at the expense of data quality or compliance. To strike this balance, our quality assurance processes are designed to be both efficient and thorough.

We prioritise early and continuous QA involvement, which is why I’m engaged in every project from initial design through to final report delivery. Quality assurance begins at the questionnaire stage, continues through the soft launch and full data collection phases, and concludes with final reporting, ensuring checks are in place at every step. This proactive approach allows us to catch issues early, prevent escalation, and maintain momentum in fieldwork.

Our data checks are tailored to the pace of each study, based on completion numbers rather than fixed timeframes. This flexibility ensures that QA efforts are aligned with real-time project progress. Our checks are also structured to build on previous findings, allowing us to become more informed and efficient as the project evolves.

We follow a standardised QA process that ensures consistency and high standards across all projects, while still allowing for flexibility where needed. When issues arise, we collaborate closely with client teams to resolve them quickly and effectively, with input from all relevant stakeholders.

Ultimately, our approach ensures that speed never compromises data integrity, patient safety, or regulatory compliance.

What excites you most about the work you do?
What makes this work truly meaningful is knowing that we’re making a real difference to patient outcomes through our commitment to compliance in the medical device industry. Every PMCF survey we support helps hospitals start or continue using life-saving devices and being part of that process is incredibly rewarding.


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Article 61(10) within the EU MDR | Notified Body Insights & the Role of PMCF Surveys