Biopharmaceutical small- and medium-sized enterprises (SMEs) running clinical trials in the EEA must comply with the GDPR like larger companies performing similar data processing activities.
However, you may not have the in-house expertise and need to outsource.
Hiring the right GDPR compliance consultancy can be challenging, but when successful can save you time, money and stress.
Outsourcing has become a routine part of doing business today. It often saves money, improves efficiency and provides services that your in-house team can’t. However, outsourcing to a GDPR consultancy can be challenging especially when noncompliance falls on you, the company collecting, storing, processing, and sharing personal data.
This article looks at how following a few key principles when choosing a GDPR compliance consultancy for your clinical trial can result in a valuable trusted partnership that can help you safeguard data subjects’ privacy and ensure GDPR compliance.
How to choose the right GDPR compliance consultancy
Firstly, when we talk about outsourcing data protection, it’s not as simple as handing everything over to someone else. It’s more of a collaborative partnership. Thus, it’s essential that the outsourced GDPR consulting service is on the same page as you and can demonstrate the following:
- Up-to-date GDPR knowledge and expertise
- Industry-specific (pharma/biotech) knowledge and experience
- Excellent reputation
- Reliable infrastructure and technological systems
- Clear key performance indicators
- Robust communication frameworks
Industry-focused GDPR knowledge and expertise
You may already have a data protection professional in-house to advise on local regulations (e.g., HIPAA, CCPA), but to expect one person to understand and apply a data protection regulation from another country, in this case, the GDPR, and feel comfortable in doing so is quite a lot to ask.
A GDPR compliance consultancy should give you access to a team of experts who work with you to support your research endeavours while ensuring you can focus on the needs of your business and move forward with your commercial goals. A team who keeps abreast of the latest regulatory changes in the EEA and their impact globally.
It’s important to remember that not all data protection consulting services are the same. The GDPR cannot be applied to your business in isolation. It must fit with your pharma working practices and work alongside regulations like the Clinical Trials Regulation (CTR). Thus, hiring a team of data protection experts with a strong biopharmaceutical industry background and experience in applying the GDPR to clinical trials in the EEA means they can leverage their broad knowledge of similar situations to advise you quickly and efficiently.
Reputation within the sector
Alongside knowledge and experience, reputation should be a critical factor in deciding whether you can work with an outsourced GDPR consultancy. Reputation goes further than whether the team of GDPR specialists can do a good job. It includes their values, purpose and ethics and whether these align with those of your business – be it honesty, transparency, integrity, or accountability.
Does what they say match what they do? When you know a company is true to its word, takes responsibility for its actions and is accountable for the impact of those actions, then you can stop worrying about slipping standards because the process is one step removed.
What do their clients say about them? The best outsourcing GDPR consultants are an extension of your existing team, not an entirely separate agency. Ensure you can work together and are completely aligned – you won’t regret it.
Reliable resources and technological systems
A GDPR compliance consultancy offers a team of experts who can use their combined knowledge and experience to work on your project, which means they can provide solutions to multiple aspects of compliance quickly and efficiently. That said, they must have access to a wide range of resources and technology, including shared systems, to ensure smooth communication and project management.
Clear key performance indicators
Key performance indicators (KPIs) are critical when measuring your investment in outsourcing. They also help to put to rest any fear that services will not deliver according to the set expectations, resulting in poor service and potential fines. Transparency on all sides is key.
From the start of the partnership, it’s vital to be clear what your expectations are and that everyone understands and agrees that the performance measures are important and the correct measures for the tasks at hand.
Robust communication frameworks
Implementing GDPR compliance requires a company-wide effort and data protection and privacy training for your staff, management and clinical teams. So, the consultants you are hiring need good communication skills.
However, good communication starts with active listening. You hire a GDPR consultant to advise, guide and help you change policies and procedures to meet compliance requirements. They will pragmatically apply their knowledge to your business and pharma working practices. But to be able to do this, they first need to listen to the challenges you are facing and the questions and concerns you have about GDPR. Only then can they fully understand your situation and your business.
The success of a GDPR compliance programme rests on communication. Thus, it’s important from the outset to agree on a communication framework to clarify how and when you will communicate with each other. Transparent, regular communication means you can keep control of risk management while allowing the GDPR consultancy to do the heavy lifting for you.
Carefully choosing your outsourced partner means you will have a trusted team of experts who will work with you, with no loss of control on your side, to deliver compliance work that meets the highest professional, ethical and business standards, avoiding potential fines and sanctions and safeguarding data subjects’ information.
How can Pharma Data Protection help you?
Are you a non-EEA pharma company looking to launch a clinical trial in the EEA or UK? Perhaps you lack the time and resources to hire a team of in-house data protection specialists?
Do you need help understanding how the GDPR affects your clinical trial or wider business?
We are more than data protection consultants. We are pharma data protection specialists. We do the heavy lifting, allowing you to concentrate on what you do best.
We pragmatically apply the EU and UK GDPR to pharma data-processing activities across international borders, ensuring the safe handling of sensitive personal data related to European clinical trials.
But don’t just take our word for it. Read what one of our biotech clients has to say about working with us: Outsourcing Data Protection – a biotech client’s perspective.
Whatever stage of the European clinical trial journey you are on, it’s never too early or too late to seek advice.
Talk to us about your GDPR compliance needs.
We are here to support you.