GDPR Compliance in Clinical Trials

The protection of personal data in clinical trials is a major concern considering for instance the health data of patients. In the European Union this was strongly enforced on 25th May 2018 as the General Data Protection Regulation (GDPR) came into effect. Consequently, this affects Non-EU sponsors since they equally need to ensure full compliance with this regulation when conducting clinical trials in the EU. To ensure the enforcement of the GDPR, sponsors are therefore required to appoint an EU Data Protection Representative. We at GCP-Service, can offer you this representation ensuring your full compliance contributing to a smooth study conduct.

The GDPR affects your clinical trial in many ways, such as proper handling & reporting of data breaches, secure data transfer to 3rd countries, dealing with sensitive data processors, appropriate training of your study team and much more. Failing to meet this regulation often leads to unnecessary study delays. We for example often observe that submission procedures are prolonged as informed consent forms lack to meet the GDPR leading to a delayed study kick off.

However, our experienced Representative team can support you in meeting the various challenges set out by the GDPR. Our experts aim to increase your transparency and ensure that all regulatory requirements are met.  We further resolve any uprising data protection issues throughout the study conduct. Among other things our service therefore includes the following:

  • effective consultancy
  • coverage of the entire European Union
  • main contact point to supervisory authorities
  • effective handling of data breaches
  • preparation and review of GDPR compliant study documentation / submission dossiers

Our EU Data Protection Representative service can further be offered in combination with our Legal Representative for drug studies (acc. EU Regulation 536/2014) and Authorized Representative for medical device studies (EU Regulation 2017/745).

If you are in need of representation services or require some advice, we are happy to support you.

Please click here to get in touch with us.

Benjamin Tsiflidis (btsiflidis@gcp-service.com)
Phone: +49 (0)421 89 67 66 15

EU LEGAL REPRESENTATION for Clinical Trials

Selecting the most suitable countries and sites for your clinical trial is a major step towards getting your study started off right. It also ensures a smooth study conduct. This becomes even more evident in view of the COVID-19 pandemic and its implications.

When considering running your study in the EU keep in mind this brings along many benefits. Generally, the EU has great social, cultural, ethnical & economic diversity. This means the incidences of different diseases and their prevalence rates are as equally diverse. From a sponsor perspective, this offers unique benefits in terms of finding the right study population and finding an acceptable risk-cost profile for your study.

Our Representative Services are designed to support you in finding the right European countries for your study. We provide you with the required expertise to ensure your study meets full regulatory compliance. We offer our regulatory expertise for both drug studies as a Legal Representative (acc. EU Regulation 536/2014) and medical device studies as an Authorized Representative (EU Regulation 2017/745). Additionally, we can represent you in the Non-EU countries of Switzerland and The United Kingdom.

To our understanding, legal Representative is an added value to your study and not seem as another mere financial burden. Legal Representative services should ensure:

  • A smooth study conduct
  • Regulatory compliance
  • Cost-efficient rates
  • Review of essential study data/documents,
  • Effective communication with regulatory authorities
  • Oversight to international sponsors (via eTMF/eISF)
  • Review of the TMF and evaluate its inspection readiness, etc.

If you are in need of representation services, we are happy to support you.

Please click here to get in touch with us.

Benjamin Tsiflidis (btsiflidis@gcp-service.com)
Phone: +49 (0)421 89 67 66 15

We use our smartphones daily, but the adoption of ePRO in the pharmaceutical industry surprising still meets resistance. This opposition is still present even considering the increasing shift to ePRO in recent years. In my opinion, ePRO should be the gold standard for PRO data capture in clinical trials.

Currently there is has been an increase in reconsidering traditional data collection strategies in clinical trials. Due to the complications COVID-19 created worldwide, paper data collection strategies became even more difficult than previously. As a consequence the benefits of ePRO became obvious, proving the underestimated power ePRO has to offer. The higher demand for ePRO from companies not using electronic capture systems came as they saw patient compliance rates fall drastically. Companies who did not want to use ePRO before COVID-19 suddenly found themselves trying to quickly obtain this service to stabilize patient reported outcomes. It is important to mention many times the quality of the paper documents collected fell short of basic standards, adding yet another barrier to data collection.

The advantages over paper-based PROs include:


Accuracy – By using direct validation methods

Integrity – Electronic time stamps and audit trails help avoid “parking lot syndrome” (filing out the PRO just before the visit)

Security – ePRO data is stored on secured servers with backup safeguards. Thus, can never be lost.

Compliance – Use of automated notifications raises patient awareness and provides valuable feedback. In addition, the patient can integrate these important, but sometimes inconvenient, tasks better in their daily life.

Speed – Data can directly be assessed, is available for remote review, and can be integrated in other systems.



Most importantly the FDA has officially stated ePROs are preferred over paper PROs. The increase in implementation of ePRO in clinical trials indicates electronic systems are effective in increasing the data capture benefits in clinical trials.

It is obvious that the advantages of ePRO will remain long after COVID-19 has passed, but the memories and outcome results during a pandemic when an electronic system was desperately needed and not used will remain much longer.

For more information please click here to contact me. Another information resource worthy of review is the European Medical Agency (EMA) reflection paper on expectations for electronic source data and the FDA’s  guidance for industry on patient-reported outcomes. ).

I look forward to supporting you with your ePRO goals.

Thomas Kissner (tkissner@gcp-service.com)
Phone: +49 (0)421 89 67 66 12

Choosing the appropriate data collection strategy has always been a key to success in clinical trials.This is even more important considering COVID-19 and its effects on clinical trials this year.

An internal survey of our current projects during this pandemic showed that those trials using ePRO (or other eCOA measures) had less delays when compared with studies using EDC alone. Unfortunately the worst case scenario occurred for paper-based or hybrid studies had to put on hold or even postponed entirely due to the consequences of the COVID-19 pandemic.

Fortunately we consistently receive positive feedback from our clients that patients using our ePRO system are more willing to participate in electronic data collection. This is part because our ePro resource allows study patients to submit their responses remotely. This eliminates a potential risk of exposure to COVID-19 as the result of being physically present for a site visit.

ePRO uses a patient focused approach to increase patient recruitment, retention, and engagement within a clinical trial. Patient compliance is increased by using flexible notifications and reminders that easily integrate into a patient’s daily schedule.

Using ePRO as BYOD makes the data entry process easier for the patient. It empowers patients to report data using their mobile phone on their own time and in the comfort and safety of their own home.

For those reconsidering their data collection strategy the Risk Assessment and Mitigation Strategies for PRO Data Collection regarding COVID-19 issued by the ePRO consortium is an excellent resource.

It is my pleasure to support you in finding the data collection strategy, whether planned or current, that’s right for you and your clinical trial.

Please click here to contact me today and don’t forget ask for a demo of our a free PRO solution software.

I look forward to hearing from you!

Thomas Kissner (tkissner@gcp-service.com)
Phone: +49 (0)421 89 67 66 12

The time in which the European Medicines Agency did not care about medical devices is over.

EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices.

The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical devices and IVDs. The Agency is working closely with the EU regulatory network and with stakeholders from the pharmaceutical and medical device industries, including notified bodies, to ensure a smooth transition to the new regulatory framework.

The biggest challenge is currently “to ensure we have the appropriate expertise and resources to adequately carry out these new tasks,” said Guido Rasi, Executive Director of Agency.

This first document developed jointly by EMA and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) in close collaboration with the European Commission, focuses on the  stipulation that marketing authorisation applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body. Approximately 25% centrally authorized medicines include a medical device component, and the majority of these involve an integral device.

EMA will publish further updates to the Q&A document addressing other requirements for various categories of devices, including those made of substances that are systemically absorbed, products which are not clearly defined as medicinal products, known as ‘borderline products’, and in vitro diagnostic tests used to determine patients’ eligibility for a specific medical treatment.

The complexity of regulations correlates with the complexity of products we develop nowadays. The increasing influence of the EMA in the medical device world is a logical consequence. Medical Device manufacturers should learn to understand their notified bodies as well as the EMA better, because EMA is watching them!

Contact us: info@gcp-service.com

Source: https://www.ema.europa.eu

Since 06 December 2018 the guideline on the content, management and archiving of the TMF is final and will be effective from 06 May 2019 onwards. All enthusiasts of paper TMFs should review the guideline carefully and honestly question their way of approaching TMF management over the last 20 years.  Sponsors of multinational studies should consider the following requirements:

  • The sponsor may choose to outsource duties and functions of the sponsor to a CRO. The sponsor remains responsible for the trial and will need to maintain oversight. Therefore, access to the CRO maintained part of the sponsor TMF or at least regular access to relevant documents from it will be necessary to fulfil these responsibilities effectively.
    Do you spend the manpower, time and money to visit your CRO and their local facilities on a regular basis to maintain TMF oversight?
  • The timelines for submission and filing of all documents to the TMF in procedural documents or TMF plans should be defined. This is particularly important for more complex TMF arrangements with multiple parties involved.
    Where timelines are defined, timelines need to be controlled. Do you control the TMF management timelines in your TMF?
  • The TMF should be managed securely at all times to ensure completeness and to prevent accidental or premature loss, unauthorized alteration or destruction of documents. Access to the TMF should be based on a role and permission description that is defined by the sponsor and/or investigator/institution.
    Do you know every storage location of the essential documents throughout the course of your studies? Have you visited the home offices of freelancers and homebased staff? Do you control whether the role-based permissions of accessing the TMF are kept?
  • As per Article 58 of the Clinical Trials Regulation (EU) No 536/2014 “unless other Union law requires archiving for a longer period, the sponsor and the investigator shall archive the content of the clinical TMF for at least 25 years after the end of the clinical trial.
    Do you have the capabilities to archive your documentation for the prolonged period, which requires more space, more manpower and little staff turnover?

After many years of experience in conducting and auditing multinational studies including TMF auditing, we have seen a large number of paper-based TMFs, stored at different locations and facilities, maintained by a large variety of people according to different cultures, rules and timelines. At least 90% of those paper TMFs did not match with the new EMA guideline on TMF management.

Most likely, if a TMF of a multination trial is to be established and managed on paper, the required resources for the TMF will let the study costs explode. Comparing costs for storage, control and manpower of an electronic TMF with a paper TMF, is similar to comparing the costs for doing a job with a computer versus using a typewriter.

The main difference is that the typewriter has been removed from most offices 30-40 years ago. It seems that the only reason for using a paper-based TMF is a nostalgic one. Without any doubt, the transition from paper to digital systems requires resources. Nevertheless, postponing this transition will cause even greater economical disadvantages for sponsors and may significantly risk the success of clinical trials and organizations.

If you need support – contact us: info@gcp-service.com

The bad news is “time flies”, the good news is “you are the pilot”. Regulation (EU) 2017/745 (MDR) will apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices, which means spring 2020. The last year to fly into the right direction started!

For the future development of medical devices, the new MDR requires:

– more clinical data;

– more robust data;

– more transparency;

– minimization of patient risks;

– better control of entire life-cycle of the medical devices.

Even though the MDR will not make the medical device world in Europe perfect, it is useless to complain. The system will be changed, and it will become more like the US system, where medical devices fall under the US drug law (CFR). Consequently, some medical devices will be removed from the market, while others will move into another risk-class. Manufacturers will need to conduct 10 times more clinical trials with their new products to receive a CE mark, which will make the medical device development more expensive. In the past many manufacturers made rough estimations on sample sizes for their trials based on the nonvalid statements of notified bodies. In future a powered sample size calculation will be required. Nevertheless, if biostatisticians qualified in  medical devices trials will be involved, we do not expect dramatic  increase in the size of the medical device trials. However, the results of these future trials should be much more powerful compared to the past.

We can see also a lot of cost saving potential for the medical device companies such as:

– moving their trials from the high cost regions to central and eastern Europe, a region that is which more cost-effective for clinical trials;

– involvement of new, highly motivated clinical sites which are much more effective compared to “old professors” (key opinion leaders serving as key opinion leaders for all, even competing companies anyway);

– changing from paper to electronic documentation as nowadays eCRFs are less expensive compared to paper CRFs;

– change from onsite monitoring to remote monitoring, especially for low or medium risk devices;

– change from manual monitoring to statistical monitoring as software can check data better than people;

– planning and designing trials more professionally, having in mind that clinical product development is no academic research.

Yes, the costs of clinical development of medical devices will increase, but as pilots should not choose the way through the thunder storm, you should not choose the expensive way into the unknown. Clinical development of medical devices might be new for many medical device companies however thousands of clinical device trials have been already performed and experienced people and companies exist. Hence do not think you need to reinvent the wheel.

If you need support with your clinical development medical device contact us: info@gcp-service.com

Why do so many companies run their clinical studies like driving with the car through the fog?

In no other industry can you find so many extremely smart people with excellent ideas to help patients, but when the clinical trial phase starts, many of those intelligent people start playing roulette. Millions of Dollars are spent to see at the end of the trial, if the results are positive in terms of efficacy and safety. If not, all money is gone. And errors during measuring or recording efficacy or safety can quickly turn a study heading the right way into one unable to show the desired outcome.

 

 

 

In most studies it is quite simple to get a better view into the data fog. Nowadays, statistical monitoring can show how our data look like during the whole course of the study and quickly identify spurious data or systematic errors before it is too late. Sponsor who use the foggy way of driving a clinical trial should not complain about the high risk of clinical research but think about more intelligent ways of conducting it. It is not enough to have smart people, people need to do smart things.

If you are interested in the topic, please contact us:

info@gcp-service.com