An added value for (non-EU) Sponsor’s & CRO’s
Legal representation unlocks the EU to your clinical studies. This of course is a major step towards getting your study started and ensuring a smooth study conduct. The Representative should therefore be a trustful partner for the sponsor providing comprehensive regulatory advice and expertise. GCP-Service strives to offer you such partnership. We are not just a post box. We are an added value.
Our expertise is reflected in our experience as we act as Representative for a wide range of sponsors and CROs across all study phases and numerous indications. We can provide representation for your medicinal and medical device studies and cover representation enforced by the General Data Protection Regulation (GDPR).
Legal Representative / European Authorized Representative
Who needs to appoint a Legal Representative / European Authorized Representative?
Sponsors of a clinical trial with pharmaceuticals who do not maintain an establishment within the EU need to appoint a Legal Representative (acc. EU Regulation 536/2014).
Sponsors of a clinical trial with medical devices who do not maintain an establishment within the EU need to appoint an European Authorized Representative (acc. EU Regulation 2017/745).or medical devices (acc. EU Regulation 2017/745).
At GCP-Service a group of highly experienced regulatory experts will provide you with competent, quick and cost-efficient representation services. We offer our expertise to you and CROs who might not be able or experienced enough to provide such services.
Depending on your needs, our representation services include the following:
- We operate in more than 30 countries and represent you in all EU member states
- We operate and represent you in Switzerland and the United Kingdom
- We ensure full regulatory compliance
- We support you in the selection of the best suitable EU member states
- We prepare your sites prior to inspections by national and international authorities
- We provide support for or perform your regulatory applications to the European authorities and ethics committees
- We can ensure oversight to international sponsors by using an electronic Trial Master File (hyperlink zu TMF service) (eTMF/eISF) according to latest regulatory standards
EU Data Protection Representative (GDPR)
Who needs to appoint an EU-Representative according to Art. 27 GDPR?
Sponsors of a clinical trial who process data of EU citizens and do not maintain an establishment within the EU need to appoint an EU Data Protection Representative.
What are the duties of an EU Data Protection Representative (GDPR)?
The EU Data Protection Representative is acting as an addressee for all matters of data processing for the purposes of ensuring compliance with the GDPR. This especially involves communication with supervisory authorities and data subjects.
At GCP-Service, we provide such representation. We established this service to ensure that our international clients meet all legal requirements pursuant to the General Data Protection Regulation and other applicable legislation. We are aware that this representation is crucial for the purpose of performing clinical research projects in the European region. Our Representative team is composed of experienced consultants and a Data Protection Officer (certified by notified body) having profound knowledge on data protection provisions in the EU.
Depending on your needs, our representation services offer the following:
- We cover the entire European territory
- We ensure overall GDPR compliance
- We provide effective consultancy
- We are the main contact point of supervisory authorities
- We prepare GDPR compliant study documentation and regulatory submissions
If your company requires EU Representation or if you are unsure whether the GDPR applies to you, we are more than happy to provide you our experience and expertise. If you are interested, please contact as for further information via firstname.lastname@example.org
As such, we deem it pivotal to involve our Biostatisticians right from the beginning of the trial, to ensure that not only the sample size, but also the hypotheses, description of estimands, definition of analyses sets and statistical models to be used, as well as the specified trial design, ensure the highest degree of confidence in the trial outcome right from the onset of planning.
During the trial, our Biostatisticians further ensure that data is monitored centrally to identify outliers and systematic errors and enable corrective and preventive actions before data integrity is jeopardised. Assistance in determining the impact of decisions made during the trial on the evaluation is further provided, to ensure . A final data review prior to the analysis further ensures that all pre-specified analyses can be conducted as desired, and necessary changes are prospectively implemented.
The final analysis of the trial and the interpretation thereof are guided by our experts. To ensure that the analysis is tailored to the needs of our clients, we prospectively visualize all analyses, which helps speed up the time from database close to having the finalized results. We further see the benefit of using our Biostatisticians to help write the Clinical Study Report, ensuring that the interpretation of the results is accurate and complete, and conclusions.
Whether you are developing a novel medicinal product, would like to expand the indication of your already available drug or aim to get a CE certification for your medical device: We are experienced and ready to support you in your endeavours. We can provide our expertise to you during different phases of your trial or throughout the whole process.
Our services include, but are not limited to:
- Pre-trial planning
- Feasibility support
- Statistical consulting
Support in study protocol development
- Trial design
- Sample size calculation (supported via nQuery)
- Description of hypotheses and estimands
- Definition of analysis sets and subgroups
- Support and preparation of randomization and blinding
- Setup of expert committees, planning of DSMB meetings
- Centralized Statistical Monitoring
- DSMB meetings, Data Review Meetings
- Interim Analyses
- Sample Size Re-estimation
- Preparation of Statistical Analysis Plan
- Preparation of mock Tables / Figures / Listings
- Complete study analysis
- Preparation of Statistical Report
- Support for Clinical Study Report
- Post-hoc Analyses
Each task is performed in accordance to the ICH GCP E9 guideline as well as our own SOPs or those of our client. We pay special attention to transparency and a close contact with the project team, so you have the overview of data at any point.