Business Benefits of Data Protection and Data Privacy in Clinical Trials in Europe

For US and other non-EU pharmaceutical or biotech companies launching clinical trials in Europe, GDPR compliance could be seen as another data protection hoop to jump through. However, apart from the legal obligation and avoidance of significant financial penalties and sanctions, GDPR data compliance can make your business more efficient, secure and competitive.

Many of the responsibilities and obligations defined by the GDPR are familiar to companies in the clinical research sector, including that of consent. Although, as we know, under the General Data Protection Regulation (GDPR), the conditions for consent to data processing have been strengthened and must be handled separately from that to participate in a clinical trial. However, when we talk about GDPR for clinical trials, we are not just talking about special category, health-related data, but also the personal data of EU citizens collected, produced and stored in all areas of the business, from employees (both internal and those of partners, contractors and vendors), to customers.

The GDPR aims to help organisations manage their personal data more efficiently, reducing the risk of data breaches and improving their interaction with data subjects. Thus, whether your compliance tasks lead to streamlining data processing and lifecycle workflows, data hygiene and clean up or even greater awareness of security vulnerabilities, GDPR has several benefits over and above privacy considerations alone. Adopting data protection best practices can even deliver long-term competitive advantages.
This article aims to take a closer look at some of these often-overlooked business benefits of GDPR compliance, including the following:

  • Improved data management
  • increased operational efficiency
  • better understanding and appreciation for the collected data
  • Creates a culture of collaboration within your business
  • Increased trust and credibility
  • competitive advantage

How can GDPR compliance improve your data management and operational efficiency?

Data management for GDPR is the process of collecting, storing, organising, maintaining, and using data effectively and efficiently. However, with the fast pace of business and the rapid increase in the amount of personal data produced, data management can be challenging, and all too easily slips down the list of priorities as more pressing business issues take up your limited time and resources.

But effective data management is essential for achieving operational efficiencies, reducing costs, and improving overall performance. But how does working towards GDPR compliance help you reprioritise and tackle data management head-on?

The first step towards GDPR compliance is to audit your existing data – what, why, where, when and how your extended organisation uses personal data – otherwise known as data mapping. Data mapping allows you to start to catalogue and organise your data, so you can decide what data you can continue collecting, what to cease collecting and what to delete. Minimising the amount of data collected and optimising processes can reduce project and operational costs.

Knowing what data you collect, where it is stored, who has access to it, and the purpose of use enables easier identification and quicker access for meeting data subjects’ rights and requests, business reporting, and faster and better decision-making, improving operational efficiency.

In addition, data mapping is an integral part of the Data Processing Impact Assessment (DPIA), a mandatory GDPR compliance task for processors of special category data, in which you must identify the technical and organisational measures you have/or need to protect each category of data. These security measures are a critical aspect of data management and help to protect sensitive information from unauthorised access, use, disclosure, disruption, modification, or destruction.

Working towards GDPR compliance offers a great opportunity to optimise your data management, reduce operational costs and improve efficiency.

How can GDPR compliance improve your understanding and appreciation of the data you collect?

The GDPR requires all personal data to be accurate and up-to-date, and inaccurate or duplicated data must be rectified or erased. This audit process is a great starting point to understand your data better and extract the most value.
To ensure the data you collect, store and share is accurate and useful to the end user, it is important to ask yourself the following questions:

  • Is the data correct? Only accurate data can lead to well-informed scientific and business decisions.
  • Is the data relevant? Does it answer the analytical question (scientific or business)?
  • Is the data well-structured? Is it in a format that meets the end-user and storage requirements – for example, is it easily searchable for information?
  • Is the data complete?

Correcting inaccuracies and inconsistencies and removing redundant data result in a better-quality database of useful data and free up valuable storage space, saving your business money.

How does working towards GDPR compliance create collaboration and shared responsibility?

It’s normal for different teams within a business to access the same data independently. Working towards GDPR compliance is a fantastic opportunity for organisational change by allowing teams to come together to demonstrate greater openness, accountability and responsibility in storing and using personal data.

Data protection/GDPR data privacy training can further enhance this process, facilitating the adoption of standardised procedures and the collaboration to establish those processes.

Clear communication and shared responsibility create a culture of data protection, reducing human error and giving you greater confidence when conducting clinical trials.

How can GDPR compliance increase trust and credibility?

Trust is essential in building and maintaining mutually respectful relationships in business – with your employees, business partners, contractors, customers and investors.

Trust is crucial for recruitment and retention. When employees know that a company is committed to data protection/privacy of their personal data, they feel more confident and secure about their workplace.

Business partners, Investors and Customers
GDPR’s Article 5 includes seven fundamental principles:

  • Lawfulness, fairness and transparency
  • Purpose limitation
  • Data minimisation
  • Accuracy
  • Storage limitation
  • Integrity and confidentiality
  • Accountability

Every potential customer, business partner or investor will carry out due diligence to ensure your company is safeguarding data as it should be and is demonstrating best practice in data protection and privacy.

Reaching full GDPR compliance signifies that your organisation has achieved a high level of data protection, follows the seven principles in making decisions regarding data protection, has a reduced likelihood of data breaches and can address potential breaches effectively and efficiently – a strength all organisations value and places you in a very powerful position to secure new business or investment.

Trust is even more critical when your partnerships involve patients and researchers in clinical trials, where there is often an inherent power imbalance.

Data breaches within clinical studies and the public/media perception that some pharmaceutical companies value profit over people can leave data subjects vulnerable and erode trust within the industry. It is, therefore, not surprising that lack of trust remains one of the most cited barriers to public participation in research.

However, through GDPR compliance, sponsors can regain participants’ trust in the clinical trial process by acknowledging these concerns upfront and addressing them through clear communication and increased transparency. GDPR compliance demonstrates to patients that you value them as true partners, not just participants.

Data breaches damage a business’s reputation, and in a highly competitive industry such as pharma and biotech, they could directly impact your bottom line.

By protecting customers’ privacy, organisations avoid penalties and build trust, unlocking hidden reputational and brand value.

This is true for businesses that collect and process consumer data and those that want to attract business customers. Your GDPR compliance becomes inextricably tied to that of a vendor as you exchange data.

It’s important to understand that GDPR compliance is a process, not an endpoint. It’s not simply checking off a series of requirements, but evolving, recalibrating and reconsidering privacy and data protection as your organisation, and the sector or industry in which it operates, develops, expands, changes, and adapts.

If you’re concerned about the time and money you will need to invest as you work towards GDPR compliance and plan for your clinical trials in Europe, reflect on the wider business benefits as you move forward. Improving data management, boosting customer trust, and reducing costly data breaches can all be meaningful for your organisation and give you the competitive advantage and ROI that your business needs to prosper.

If you’re wondering about initial steps towards GDPR compliance or have a more complex question, Pharma Data Protection consultants have a wealth of experience in both pharma and data protection and can set you on the right path.

Talk to us about GDPR and your planned EU or UK clinical trials