eNews July 2021

EUCROF held its Spring General Assembly Thursday 3rd and Friday 4th June 2021. Due to the continued COVID-19 pandemic and resulting travel restrictions, the GA was again held remotely via GoToWebinar. The meeting was a great success with over 30 representatives on each day from our membership in attendance over the two days and for the first time this included EUCROF Affiliates (CROs that are members of their national Association and that are, in turn, Members of EUCROF).

Martine Dehlinger-Kremer, our President, welcomed all participants attending the General Assembly and introduced the following agenda:

Day One:

Interim Progress Report 2021

Financial Report 2019 (Vote)

EUCROF Conference in Madrid 2022

EUCROF Conference 2024

EU Data Protection Regulation: Code of Conduct

Working Groups (WG) Update:

• Clinical Trial Centres
• Clinical Trial Legislation
• Communication
• Innovative Medicine
• Medical Devices
• New Technologies
• Paediatrics
• Patients’ Association
• Pharmacovigilance
• Real World Data & Digital Health

Day Two:

EUCROF 2021 (June - December 2021): Objectives and Priorities

Outcome and planned Webinars for 2021

EU CTR & Update on EMA’s Clinical Trial Information System

Benchmarking project

Remote Source Data Verification Initiative

Executive Board mandates

Autumn General Assembly – Logistics

Brexit and the implications on clinical research

Closing Remarks.

As you can see, it was an extensive agenda with many important subjects presented and discussed. For each of the agenda topics above, there are slides available for reference and the minutes of the meeting, all of which are available in the Members’ area on the EUCROF website by clicking HERE. We hope the Fall GA will be face-to-face in Munich on 2nd & 3rd December 2021.

For further information please contact the Secretary via email on This email address is being protected from spambots. You need JavaScript enabled to view it. or This email address is being protected from spambots. You need JavaScript enabled to view it. and/or our President on This email address is being protected from spambots. You need JavaScript enabled to view it..

EUCROF’S New Technologies Working Group has been developing the GDPR Code of Conduct for several years. In recent times, it has achieved a number of important milestones. The code is currently in co-review phase and comments have been received from the 2 DPAs (Belgium and the Land of Bavaria in Germany). By the end of Summer, all the rework that needs to be done will be accomplished by the Task Force. The lead DPA, CNIL, has agreed that the revised Code (considering the comments resulting from the co-review phase) will be delivered back to CNIL around 15th September and will then be distributed to all 27 EU Member States’ DPA. The whole process should be completed by March 2022.

In parallel, EUCROF is making steps to establish the Monitoring Board to provide the independent oversight of the Code once it is implemented and is in discussion with a number of stakeholders with a view to gaining their contribution and involvement.

A Communication Strategy has been prepared and issued to EUCROF’s members. Going forward, it will be important for the success of the Code to ensure there is awareness and understanding of the benefits of the Code among all stakeholders of clinical trials.

Consult EUCROF website for future updates on the important initiative. 

The New Technologies Working Group has recently developed and issued an eConsent Implementation Guide.

This is a significant step in an important area in clinical research and our thanks to the team for developing the Guide.  To read the Guide please CLICK HERE. We are also preparing a position paper which will be published in the next few months.

Also, the above Guide was presented in a EUCROF webinar, the recording of which is still available in the eLearnIN Platform. For more information please contact Assia Rosati via This email address is being protected from spambots. You need JavaScript enabled to view it.. 

The webinar programme organised by EUCROF’s Events & Training Working Group have continued to be highly successful in the first 6 months of 2021, continuing the trend of a highly productive 2020.

Overview: In the light of a global pandemic, clinical research in early-stage development reached a new degree of interest as the world relies on scientists to find solutions for unmet medical needs. Under the pressure of this scenario, all parties involved in clinical research have to re-organise the working floor and find to ensure the utmost safety of trial participants while in parallel improve the productivity and speed. In drug development, the most sensitive part is the switch from non-clinical to clinical conduct, namely the First-in-Human/First-in-Patient (FIH/FIP) Phase I clinical trials.

To ensure utmost safety, a trial specific risk analysis and risk-minimizing measures are required for trial design and protocol, as well as for the translation into practical conduct for executing infrastructures in specialised Phase I research clinics. The basic principles of safety arrangements in clinical trials are regulated by international guidelines and local laws and requirements. For the EU countries, the Clinical Trials Regulation 536/2014 based on ICH GCP E6 is implemented as binding law for the conduct of clinical trials. Since this law does not distinguish between the different phases of drug development, starting with FIH/FIP Phase I up to confirmatory Phase III trials, the EMA took action in 2017 to update the guideline for FIH/FIP clinical trials which states that “the early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate”.

This webinar will help you understand more about the risks and benefits of early-stage clinical trials conducted in specialised Phase I research clinics. It will highlight the points to be considered for planning and conduct of Phase I trials:

• safety management plan
• adequate personal resources
• adequate locations/wards
• adequate technical equipment
• processes for management of emergencies
• adequate conditions for PK sample, collection, handling, and processing.

There was another webinar delivered on 25th May (third of 2021), very well attended with 107 participants! It was entitled “GDPR and Clinical Trials: Compliance and Harmonisation”. The presenters were Kate Smirnova, Data Protection Officer (DPO), PSI CRO, Victoria Watts, Vice President, Privacy and Global Data Protection Officer, Premier Research and Thierry Lepoutre, Manager Clinical Operations, Telemedicine Technologies.

Overview: The GDPR (General Data Protection Regulation) has been with us for three years now. Yet, the industry continues to struggle through the multiple legal interpretations of how the GDPR requirements apply to the clinical research. Ethics committees, data protection officers of the clinical sites and of study funding sponsors, as well as the other stakeholders, defend their approaches. This altogether expands the gap in how a CRO and therefore, a Sponsor should process personal data to state with confidence, “We are GDPR compliant”. To enable mutual agreement on the rules of applying the GDPR requirements to clinical research and help CROs demonstrate compliance with the GDPR, the EUCROF task force initiated, developed and now is proud to introduce the first Code of Conduct in the industry. The Code is aimed to explain the application of the GDPR to the services delivered by the CROs. 25 May 2021, on the day of the 3rd anniversary of the GDPR, the presenters guided attendees through the first clinical trial Code of Conduct. Attendees had the opportunity to ask questions about the Code and our reasons to trust in its value, as well as receive practical advice on adherence.

The fourth webinar of the year took place on 21st June 2021 with 48 attendees. It was entitled ‘Electronic Informed Consent ... bringing the clinical trial home’ and was presented by Fiona Maini BSc. MSc, Principal Global Compliance and Strategy, Medidata Solutions a Dassault Systèmes Company, Mika Lindroos, Signant Health - Director, Product Management, eConsent and Valeria Orlova, Medidata Solutions a Dassault Systèmes Company.

Overview: This webinar on electronic Informed Consent (eConsent) addressed the practical considerations when implementing eConsent. This topic has become an ever increasingly important topic as remote strategies and decentralised clinical trials are being deployed. The session started with an introduction to the eConsent Implementation Practical Guide, which was published earlier this year. The Guide was developed by EUCROF and eClinical Forum members. It addresses key themes and hot topics and provides a view on the modernisation of the clinical trials informed consenting process, including the current perception and shift of eConsent adoption in light of the COVID-19 pandemic.

Some of the topics addressed in the presentation included:

• eCF and EUCROF eConsent task force activities
• eConsent fundamentals
• eConsent Implementation Guide
• o Introduction to the eConsent Implementation Guide
• o Stakeholder Perspectives
• o Implementation steps and considerations
• o Regulatory landscape - Overview of draft ICH E6 (R3) relating to informed consent.

Note, the recording of each of the above webinars is available in the eLearnIN Platform if you wish to listen to it. For more information please contact Assia Rosati via This email address is being protected from spambots. You need JavaScript enabled to view it..

New members are required to join EUCRO New Technologies Working Group (NTWG), specifically to contribute as part of a new Task Force on AI/ML.

AI technologies have penetrated every industry, including Clinical Research. The NTWG, is addressing – among other topics – the challenges of AI/ML in clinical research and more specifically:

• Changes and effects in clinical research made necessary by the use of AI;
• Considerations of ethical issues.
• Overarching approach of "Good Design" and the establishment of "Good Machine Learning Practice" (GMLP)
• Participating and interacting with the regulatory authorities on the use of AI/ML for clinical research
• Access to data for training of AI/ML systems and associated technologies such as big data, real world evidence, health hubs, etc.
• Dissemination & standardisation efforts of the industry
• Use of AI/ML in risk-based monitoring
• Generation of synthetic data in-silico trials
• Digital biomarkers and prediction of outcomes
• Impact of ML on continuous QA management and system validation
• Risk stratification.

Under the framework of the activities of the Task Force, NTWG is looking for volunteers with background in:

• Regulatory aspects related to AI in clinical research
• AI/ML engineers with applications in Life Sciences
• Virtualised Diagnostics and Clinical decision-making Environment
• Explainable AI in Life Sciences
• AutoML for development of optimised AI/ML pipelines in Clinical Research
• AI security experts.

The Task Force will investigate cooperation with similar initiatives from other industry organisations.

If interested, kindly get directly in touch with Alan Yeomans (This email address is being protected from spambots. You need JavaScript enabled to view it.).

EMA communication: "Human Medicines Highlights" Newsletter – February 2021 issue

The latest edition of the EMA’s monthly Newsletter included decisions by their Scientific Committees and updates on medicines safety.

You can access the Newsletter by

The EUCROF Patients’ Associations Working Group (PAWG) would be glad to have new members joining.

The development of a patient-centred approach to medicine is gradually allowing more patients to be involved and better engaged in their own medical decisions. To this aim, a stronger collaboration between stakeholders from clinical research and patients’ associations needs to be developed.

In this perspective, EUCROF has created a PAWG with the aim of engaging with Patients’ Associations and define the best practices and collaboration to allow patients to participate more actively in the entire research process and be a leverage for our business.

The Working group will set up collaborations between EUCROF and Patients’ Associations at pan-European level with the aim of fostering an actual and confident collaboration with patients in clinical research.

Specifically, the PAWG will:

• Contribute to promote and disseminate best practices of collaboration between EUCROF and Patients’ Associations.
• Ease the effort of CROs, which need to involve patients in national and/or international projects.
• Ensure involvement of EUCROF as a stakeholder, providing consolidated CROs’ perspectives about the operational collaboration with patients in clinical research.
• Contribute to the recognition by authorities, industry and patients’ advocacy groups of best practices of collaboration with patients in clinical studies and access to innovation.
• Create and maintain an annual observatory of patient-centricity experiences and patients associations’ expectations about clinical studies across European countries, promoting the harmonisation of Patient Engagement Responsible/Unit definition.

If you are interested in joining the EUCROF Patients WG, please contact Mariangela Lupo directly via This email address is being protected from spambots. You need JavaScript enabled to view it..

Despite the ongoing challenges presented by the COVID-19 pandemic, the first half of 2021 has been busy with colleagues representing EUCROF at multiple meetings across a number of topics. Our thanks to all those who have represented EUCROF during the last few months.

• CTIS user persona workshops with the EMA – a virtual meeting on 23 May 2021 attended by Dagmar Chase and Patrice Marchand
• The Value of Clinical Experimentation - High School of Economics and Management of Health Systems (ALTEMS) - Virtual Meeting on 25 May 2021 attended by Stefano Marini
• Meeting with EU Commission on Clinical Trial Regulation and SM/NSM - EU Commission -          Virtual Meeting on 25 May 2021 attended by Dr Martine Dehlinger-Kremer & Dagmar Chase.
• 94th Meeting of Pharmaceutical Committee. Legislative framework to support patient centred, innovation & scientific development & Incentives for innovations that reaches the patient - EU Commission - Virtual Meeting on 28 May 2021 attended by Dr Martine Dehlinger-Kremer, Donato Bonifazi, Arnet van den Brink - van Dijk and Palán Ondřej.
• Enpr-EMA Coordinating Group Meeting - Virtual Meeting on 29 June 2021 attended by Dr Martine Dehlinger-Kremer
• EU matchmaking event on COVID-19 therapeutics - EU Commission - Virtual Meeting on 12-13 July 2021 attended by Dr Martine Dehlinger-Kremer
• EMA CTIS Stakeholder Meeting – Virtual meeting on 23 July attended by Dr Martine Dehlinger-Kremer, Dagmar Chase, and Simon Lee.

EMA Clinical Trials Information System Joint Controllership Arrangement – virtual meeting on 28 July attended by Dr Martine Dehlinger-Kremer, Simon Lee, Yoani Matsakis and Kate Smirnova. 

As reported in the last Newsletter on 21 April 2021, Fergus Sweeney, Head, Clinical Studies and Manu-facturing at the European Medicines Agency, announced that the EMA Management Board during its extraordinary meeting confirmed that it had verified that the clinical trial EU Portal and Database (CTIS) had met the agreed requirements, following an independent audit of the IT system and that it was now fully functional and on track to go live by 31 January 2022. This is an important milestone for the CTIS and now it continues with the final phases of the systems development in the coming months. At the most recent Stakeholder meeting, the EMA confirmed that the implementation of the CTIS was still on track for this date.

The CTIS high level training programme continued to be progressed with EUCROF very much at the forefront of the ongoing work. To this end, Marieke Meulemans (from GCP Central, a member of ACRON) continues to lead activities representing EUCROF and also all the industry associations ACRO, EUCOPE, EuropaBio, EFPIA, and VE.

However, stakeholders last month were informed that the development process to produce CTIS training materials would change in July 2021. The CTIS training material production started in March 2020 and has developed 18 out of the 24 modules that make up the CTIS training catalogue. To date, the EMA and the stakeholders group have developed and published almost all sponsor modules and continue to create the pending modules (Member States and sponsors) for publication on the EMA website: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation/clinical-trials-information-system-ctis-training-programme.

In parallel the team will start the activity to revise existing published training materials to ensure that they will match the go-live version of CTIS as we are aiming to Go Live 31 Jan 2022.

The revisions of existing training materials will stem from feedback received and captured by the team over time from different channels.

The EMA has again expressed its thanks to the experts contributing for sponsors over time and most recently to Ruediger Pankow (ACRO), Gaby Di Matteo (EFPIA), Marijke Meulemans (EUCROF, EFPIA, ACRO, EuropaBio and Vaccines Europe) and Stephanie Kromar (EORTC) who have contributed to the development of training materials together with the CTIS training team in Q2 of 2021.

Nonetheless the EMA has changed the approach to expert engagement as in the future the EMA will approach CTIS system experts and specific target user group experts to provide input to its training material production/revision for sponsor-related modules.

To implement this approach, as of July 2021 the EMA and stakeholders started to create the training material module ‘CTIS for SMEs and academia’, taking the specific user needs into account. A number of experts have been identified and once again this includes, on behalf of EUCROF and supported by EFPIA, EuropaBio and Medicines for Europe, Marieke Meulemans (from GCP Central, a member of ACRON) for additional training expertise to the expert validators group. Our continued thanks to Marieke for undertaking this role and continuing the hard work and giving time required.

Finally the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) have launched a survey on the main challenges for clinical trial authorization and reporting in the EU . As EUCROF is a key stakeholder in relation to the clinical trials system in the EU, Stakeholder Survey on Main Challenges for the Clinical Trials System in the EU was completed by Dagmar Chase on behalf of EUCROF by the deadline of 22 May 2021. The survey focussed on five challenges relating to the clinical trials system and we welcome you to propose how we should tackle these challenges going forward. In addition, you are kindly asked to point to other challenges not covered by the survey that you believe should be prioritised by the European and national authorities.

Please remember to find the online training modules here: s/clinical-trial-regulation/clinical-trials-information-system-ctis-training-programme. If you have any questions, please contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it., who will direct your enquiry as appropriate.

• EMA consultation: Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals - step 2b

The European Medicines Agency has published for public consultation an “Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals - step 2b”.

The European Medicines Agency has published for public consultation an “Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals - step 2b”.

This Addendum expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals by introducing an additional approach that is not described in the original S1B Guideline. This is an integrative approach that provides specific weight of evidence [WoE] criteria that inform whether or not a 2-year rat study adds value in completing a human carcinogenicity risk assessment. The Addendum also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model, while all other aspects of the recommendations for high dose selection in S1C(R2) Guideline would still apply.

Application of this integrative approach would reduce the use of animals in accordance with the 3Rs (reduce/refine/replace) principles, and shift resources to focus onto generating more scientific mechanism-based carcinogenicity assessments, while promoting safe and ethical development of new small molecule pharmaceuticals.

Comments should be provided using this template and sent to This email address is being protected from spambots. You need JavaScript enabled to view it. by 22 October 2021.

• EMA communication: "Human Medicines Highlights" Newsletter - July 2021 issue

Latest edition of the monthly Newsletter which includes decisions by our Scientific Committees and updates on medicines safety. We hope that you will find this useful and welcome any feedback.

You can access the Newsletter by clicking HERE. Previous editions can also be found on this page.

• EMA Consultation: Call for scientific data for use in HMPC assessment work on Tribuli terrestris herba

The Committee on Herbal Medicinal Products (HMPC) invites all interested parties to submit any scientific data, which may be used in the assessment of Tribulus terrestris L., herba as part of the establishment of European Union herbal monographs and/or European Union list entries.

• Tribuli terrestris herba

Scientific contribution should be sent to This email address is being protected from spambots. You need JavaScript enabled to view it. by 15 September 2021. Click HERE for more information.

https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-tribuli-terrestris-herba_en.pdf

• EMA: Your feedback: Study on the possible revision of EMA Fee Legislation

The EMA is writing regarding the potential revisions to the EU legislation governing the EMA fee system, in your capacity as a stakeholder representative contacted for the targeted consultation.

Please be aware that the EMA made some changes to the fee grids, and in response to that the EMA decided to extend the deadline to 23 August.

The EMA sincerely hope this extension provides sufficient time to consider these changes in relation to your assessment of the potential revisions. Should you have any questions, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

Progress is being made with this research project with the goal of mapping the CRO landscape in Europe. The project lead is Gert-Jan Dossche, a pharmacist and currently undertaking an additional master’s in business economics, plus following the ECCRT Junior Clinical Researcher star programme.

Contact points and deputies have been obtained from 20 of our Members, Associate Members and Partners and the plan is to start preparing in the coming months with the project commencing in April and running through to end June. 

 Details of the role being undertaken are as follows: -

• Undertake research project, including a survey and analysis of the financial balances of the CRO companies to benchmark the CRO landscape in Europe. This could potentially form part of a master’s qualification.
• Develop the survey, including timelines, under the instruction of the Executive Board or a delegated thereof.
• Liaise with EUCROF Members to issue the survey for completion by their members and other CROs that are located in their respective countries.
• Liaise with EUCROF Members in the countries to coordinate the collection of the financial balance sheets of the companies in a harmonised way.
• Collate the data and prepare a draft report for review by the EUCROF Executive Board.
• Present the final report to the EUCROF Members at a General Assembly.
• Identify opportunities to publish the report in an appropriate journal.

Watch out for further updates in future Newsletters and EUCROF’s website. In the meantime, any queries should be sent to Assia Rosati at This email address is being protected from spambots. You need JavaScript enabled to view it..

As previously reported, EUCROF Affiliates suggested the setup of a repository of individual CRO companies and the proposed initiative was discussed and approved at the General Assembly in December 2019. Subsequently, the Platform has now been developed and Member companies have populated it with their details, enabling its launch in July 2020.

Since then, over 260 companies out of the 399 affiliated member CROs are identified on the platform, but many more could be created with the support of our Member Associations. The CRO platform has already triggered some requests for information from visitors, which is great news. Even so, this can be enhanced, as too few companies on the CRO platform are still to fully complete their profiles, which reduces their chances of generating some business interest. Actions will be taken by the Communications WG to trigger the better completion of individual company profiles.

Overall, this is an exciting initiative which we believe will be beneficial to all those companies associated with EUCROF.  We wish to thank Christophe Golenvaux, chair of the Communication WG, who is leading this initiative.

Further update will be provided in the next Newsletter. In the meantime, contact Assia Rosati via email on This email address is being protected from spambots. You need JavaScript enabled to view it., who will direct your enquiry as appropriate.