Data compliance for organizations conducting clinical trials.

No matter what country your organization is conducting its clinical trials, we can help you ensure total compliance.
Leverage our clinical trial expertise

Every country has its own requirements when it comes to clinical trials.

Each country has its own health, safety, and/or food administration body responsible for both issuing guidelines and granting authorization to conduct clinical trials. As a result, the requirements you need to account for and be compliant with are entirely dependent on the country where you are hosting the clinical trial.

For example, all clinical trials in France need to pass through the National Agency for the Safety of Medicines and Health Products (ANSM) whereas in the USA those same trials need to pass through the Food & Drug Administration (FDA).

Keeping track of the necessary requirements is critical to avoid any regulatory downfall. With DPO Consulting, we help you navigate these guidelines with total clarity, no matter what country you host your clinical trials in.
Our services

Clinical trial compliance expertise for both France and the rest of the world.

With a strong competency for clinical trial compliance in France specifically, our expertise also extends globally. As such, we can support your clinical trial compliance needs no matter where your organization is conducting them.

Clinical Trial Agreements (CTA)

Contracts between researcher and sponsor, we’ll help ensure your CTAs are as per the required guidelines.

Informed Consent Forms (ICF)

Used to educate a patient about all the risks and benefits of a given procedure. We help you facilitate the creation of them.

Localized understanding

For organizations conducting trials in one or multiple countries, we’ll help you outline all the compliance requirements you’ll need to account for.

End-to-end compliance

From outlining the compliance requirements to securing authorization, we help you with the entire clinical trial compliance process.

Data Privacy Impact Assessments (DPIA)

We help evaluate potential data privacy risks with thorough privacy impact assessments that ensure you remain GDPR compliant.

Support with your contractual framework

Drafting clauses and contracts, doing contractual review, approaches to the competent national authorities, MR / authorization, clause and endorsement, information for patients and/or collaborators - we do it all.

Join leading pharma organizations in partnering with DPO Consulting.

Support packages based on your needs.

Select from either a dedicated number of days per month, a flat-rate, or TJM support.
Starting price per month
Learn more
Package includes
Short training
Assistance with research qualification (initial documents) 
Assistance in setting up MR and/or authorization 
Reread PIA (see if template/frame is provided or not) 
Point of contact with supervisory authority
Analysis and commentary on draft subcontractor contracts (simple proofreading - review and some marginal comments) 
Support for clinical trials outside the EU
Starting price per month
Learn more
Package includes
Everything included in Classic
Training for independent clinical project qualification (dedicated tool) 
Determination of MR and/or authorization accompanied by completion of regulatory requirements with the teams concerned
Document analysis 
Drawing up a compliance program 
Prioritization and distribution of tasks 
Draft clauses and contracts 
Contractual review
Approaches to the competent national authorities, if necessary 
MR / authorization  
Clause and endorsement
Information for patients and/or collaborators 
Steering of research project compliance 
Involvement of the DPO in contract negotiations, meetings, and review of data circuit security

Get in touch with one of our GDPR compliance experts.

Whether you have a clear idea of your DPO needs or not, our team can help point you in the right direction and understand what needs to get done.
The data collected on this form are intended for DPO Consulting. They are used to process your request. They are also used at ends of prospections except if you express your opposition to it by notching the box below. Mandatory data are indicated on the form by an asterisk. In accordance with the EU Regulation 2016/679 of 27 April 2016 on the protection of personal data and the amended Law "Informatique et Libertés" of 6 January 1978, you have the right to the access, rectification, deletion, portability as well as limitation and opposition to the processing of your personal data. You can exercise that right by sending an email to the following address:

For more information about the processing of your personal data by DPO Consulting, you can consult the Data Protection Policy.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Commonly asked questions on clinical trial compliance.

What is clinical trial compliance?

Clinical trial compliance is all about reconciling clinical trials with the GDPR. This includes framing data processing, supervising the various data transfers, applying the rights of data subjects and dealing with the relevant national authorities. The objective is to ensure, within the meaning of the GDPR, the implementation of the clinical study. This is done by supporting all parties in applying the legal and regulatory requirements linked to data protection.

How to identify the stakeholders of a clinical trial?

In the form of project management, we hold a scoping meeting from which we determine an action plan that we prioritize for you. We then qualify the parties and propose appropriate agreements. Our actions are based on a deployment logic to meet your deadlines. You need to check whether the GDPR applies to the study in question. If the latter applies, we need to define the type of research to be carried out, and check under which regime it will be carried out. That is, does the research in question fall under the regime of a declaration of compliance with a reference methodology or under the regime of prior authorization. An in-depth study of the Research Protocol, established research contracts or any other document relating to the study should be carried out, in order to prepare for adequate compliance

How do you check compliance in a clinical study?

In order to verify the compliance of your clinical trials, we use the European GDPR regulation. This is binding for both organizations established in the EU that processes personal data (both on its on behalf and not), as well as organizations established outside of the EU that are targeting European residents.

We also have the possibility, when the case arises, to check national laws when the GDPR cannot be applied in the deployment of your clinical trial.

How are clinical trials regulated in the EU?

The legal and regulatory framework is determined on a case-by-case basis according to the design of the respective research project.

Clinical trials are subject to a regulatory prism impacting health law, data protection law and exploitation rights. Depending on the project, the data collected, compiled, used (via AI, for example) or transferred, may be subject to requests for authorization or declaration of conformity from European or national authorities (CNIL, FDA, ANSM, EMA, ethical standards outlined in the Declaration of Helsinki, etc.).

In the European Union, this involves determining the applicable reference methodology with regard to:

1. Whether or not the research involves human persons (Research Involving the Human Person – « RIPH ») or not (use of products of the human body)

2. Whether or not the research is interventional (modification of care in order to carry out the research)

3. Whether the research requires the use of specific technologies or materials, etc.

What is Good Clinical Practice (GPC)?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

How does DPO Consulting support with clinical trial compliance?

Our role is to prepare you for compliance, by presenting you with the priority projects you need to carry out to comply with data protection rules.

With our two formulas, we offer you real support with:

  • Qualifying your clinical projects.
  • Document analysis.
  • Developing a compliance program.
  • Contractual negotiations with the various parties for the related Data Protection terms and conditions and contractual review.
  • Examining the security of data circuits.

In summary, our aim is to enable you to carry out your projects in full compliance, while streamlining the management of your personal data.