eNews July 2020

EUCROF held its Spring General Assembly Thursday 4th and Friday 5th June 2020. This was the first time we have held a GA remotely via GoToWebinar. It was originally planned to hold the GA in Bucharest, Romania, but due to the global COVID-19 pandemic we had to change our plans. Hopefully there will be the opportunity to hold a General Assembly in Romania on another occasion, but our sincere thanks to our Romanian colleagues of ACCSCR for their kind consideration.

The meeting was a great success with over 45 representatives 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 2020

Financial Report 2019 (Vote)

EUCROF Conference in Madrid 2022

Identify the Organising Committee, Programme Committee and Communication Committee

Organising Agency: AIM or another Agency (Vote)

EU Data Protection Regulation: Code of Conduct

Working Groups (WG) Update

Day Two

EUCROF 2020 (Jun 2020 - Dec 2020) Objectives and Priorities

Database with EUCROF CRO Affiliates’ offered services

Outcome and planned Webinars for 2020

Revision of the EUCROF Bylaws – vote

Coronavirus and impact on CROs’ landscape – Members’ Feedback and Open Discussion

System Update on EMA’s Clinical Trial Information System

Autumn General Assembly – Logistics

Brexit – update

Closing Remarks

As you can see, it was an extensive agenda with many important topics presented and discussed. For each of the agenda topics above there are slides available for reference and further detail plus also the minutes of the meeting, all of which are available in the Members’ area on the EUCROF website by clicking HERE.

The Fall General Assembly, which was scheduled to take place in Tbilisi, Georgia with the support of our colleagues of SMO-Pharmina, on 3rd to 4th December 2020, will now take place in Munich instead. Again, this change has been caused by the travel restrictions due to COVID-19.

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..

These are clearly unprecedented times with the global outbreak of COVID-19 impacting all aspects of society and businesses. Given the widespread impact across Europe, undoubtedly all of EUCROF’s members will have been affected in some way over the last few months. EUCROF has continued to try to assist its members as follows: -

• EUCROF Website

In order to help support our members during these challenging and difficult times, a specific section for COVID-19 Pandemic has been set up on our website, which provides information on new guidance in Europe (EMA and further authorities (27 MS, UK), US. We hope you are finding this useful.

• EUCROF Survey

As you may be aware EUCROF undertook a survey of its members relating to COVID-19. Intense research efforts and collaboration that have already started to identify medicines for COVID-19 pandemic. Inevitably, we have EUCROF members involved in this research and, through this survey, wanted to get a better overview of how large the contribution of EUCROF is and promote this in a positive way to a broader audience. Thank you to all those who managed to complete it.

The results were very interesting to the extent that a paper is to be published entitled ‘The current status of European research related to COVID-19 - EUCROF Survey’, prepared by Mariangela Lupo, Head of Development & Networking at Consorzio per Valutazioni Biologiche e Farmacologiche and Emma Akuffo, Director of Study Management at Richmond Pharmacology Ltd.. [Mariangela was the one who prepared the article and Emma gave her contribution, by adding and integrating further information]

In total 68 responses to the survey were received from Members and affiliated CROs and analysed electronically. The analysis of the results showed that more than two-thirds of the respondent companies (77,9 %, as shown in Figure 1) are involved in COVID-19-related research activities and 76,2 %, expect to maintain and continue with this research for at least a further 3 – 6 months. The results also show the majority of current research is focused on a potential therapeutic, nearly 40 % on test vaccines and 20 % on test diagnostics. The focus of research activities is most commonly clinical monitoring (72,3 %), project management (70,8 %) and data management (66,2 %), in the centre of their core business are regulatory affairs, statistics and medical writing.

The responders were mainly international companies/CRO's providing research services on an international level (76,1 %).

Look out on our website for when the paper is published.

• EUCROF Clinical Trials Legislation Working Group contributing to EU Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic

The EUCROF Clinical Trials Legislation Working Group (CTL WG) is aimed to represent our members and partners when input is sought from stakeholders by EU legislators and others (e.g., ICH) in the context of clinical trials. The year 2020 has been predominated by the discussion around the exceptional situation of conducting clinical trials during the Coronavirus pandemic and subsequent data analysis. An increased number of protocol deviations is expected and has to be dealt with when evaluating the data. Will these exceptional circumstances in the end impact clinical trial quality and results?

The CTL WG contributed to both, the current EU Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic which had been published on 28 April 2020 and also to the EU Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials.

The Guidance Document encourages all Member States to adopt the provisions. However, as national legislation might differ in certain aspects from the EU harmonised Guidance, many MSs came up with more detailed requirements, tailored to local legislations. EUCROF took the initiative to launch a survey with the aim to identify those differences. The results are published on the EUCROF Website for internal use. If a EUCROF member or partner is interested in a certain country, that member/partner can first go to an overview table which points out as to which aspects differences might exist and then drill down further to learn about these differences.

The two topics that are of most practical interest are the distribution of Investigation Medicinal Products (IMPs) to patients’ homes and remote source data verification (rSDV). Unfortunately, rSDV is only accepted under very limited circumstances, when the trial is targeting a COVID-19 treatment or prevention and represents a pivotal trial that is in the final data cleaning steps before database lock, investigating serious or life-threatening conditions with no satisfactory treatment options. This means that for all other trials, rSDV is not an option – rather SDV should be postponed until after the crisis for the case that no physical visits are possible to the sites. It is probably a valid assumption that some of the initially planned monitoring activities will, in the end, not happen and the question can be raised whether this will have an additional negative impact on clinical trial results: more protocol deviations during the Corona pandemic with less monitoring activities taking place. 

EUCROF CTL WG and EUCROF president will follow-up the topic and will continue to represent EUCROF in the best interest of our members and partners.

If you are interested to become a member of the CTL WG, please send your short biography to This email address is being protected from spambots. You need JavaScript enabled to view it.. Our WG is welcoming new members at any time.

• EMA communication: COVID-19: EMA meetings with delegates and experts will be held virtually until end of September 2020

EMA has taken steps to reduce the further spread of COVID-19, with the aim of protecting staff, delegates and experts and playing their part as responsible citizens in the host country, the Netherlands.

Until the end of September 2020, EMA is hosting all committee and working party meetings virtually. It is postponing stakeholder events or holding them virtually.

As of 16 March 2020, most EMA staff are working remotely.

These measures are in line with the steps taken by the European Commission and the Dutch Government’s coronavirus containment efforts.

These measures do not impact EMA’s core activities related to the evaluation and supervision of medicines.

EMA is continuously reviewing and adapting these measures as necessary.

Webinars held by EUCROF’s Events & Training Working Group have continued to be highly successful in the last quarter.

The most recent was on the topic of COVID-19 in the Paediatric Population on 24 July 2020. The presenter was Alex Cvetkovic Muntañola, MD of Syneos Health, Barcelona, Spain.

Webinar Overview:

The presentation covered epidemiology, infectivity and incubation period, mode of transmission, clinical presentation, prevention, socio-ecological impact, frequently asked questions, and clinical trials with COVID-19 together with the risk management. Our thanks to all those involved for making this successful.

On June 30th we held a webinar entitled ‘Electronic Informed Consent … a global perspective’. The presenters were Fiona Maini, Principal Global Compliance and Strategy at Medidata Solutions, a Dassault Systèmes Company, and Mika Lindroos, Director Product Management at Signant Health. There were an amazing 116 attendees registered for this webinar. Thanks to all.

Webinar Overview:

The patient centric benefits of electronic informed consenting (eConsent) technologies have been well documented, from the provision of better educational mechanisms of informing patients and overall improved comprehension of the study.

There is variability in permissible laws around the European region and globally to be aware of.

The presentation provided an introduction and overview of the:

• History of eConsent and established practices globally.
• The eConsent processes for patients, sites and sponsors: use of multimedia tools for informing and educating a trial participant plus use of electronic and wet ink signatures.
• Common EU regulatory considerations including GCP, GDPR, eIDAS and other national considerations.
• Overview of eConsent case studies.

Also, a webinar focused on the impact of COVID-19 on Clinical Trials was given by Eric Klaver on 26 May.  It was entitled “How to deal with Clinical Trials following the new Guidelines under COVID-19 Pandemic”. Thank you to the 111 participants, who attended.

Webinar Overview:

Hospitals are over-burdened and people have to stay home as much as possible. How are we dealing with study visits and other aspects of the trials?

This webinar sheds light on a risk-based approach to ongoing trials and the international guidance that has been released, to protect trial subjects as much as possible and limit the damage to ongoing trials as much as possible. The webinar highlights the situation for the sites as well as for the sponsor/CROs, goes into dealing with quality control, and looks to find opportunities that may come from this difficult time.

The EUCROF Executive Board is pleased to announce that Vicki Iassonidou (AFCRO & PRA Health Services) has been selected and approved by the EMA to become EUCROF’s second Product Owner (PO), following conclusion of a recent selection process. Vicki, in her PO role, will join the Sponsor PO team lead by Pierre Omnes and including Lydia Domingues, who also acts as a PO on behalf of EUCROF.  

These POs are playing a vital role in the development of the EMA’s Clinical Trial Information System (CTIS), which is a prerequisite to the implementation of the EU Clinical Trial Regulation. The CTIS is at a crucial stage of its development in the coming months, ahead of its audit, which is scheduled to start in December 2020.

Congratulations to Vicki for being selected as a PO and please join EUCROF’s Executive Board in wishing Vicki every success in her new role. Also, our sincere thanks to the other candidates and their respective companies and national associations, Silvia Cristofanon (PPD & AICRO) and Konstantina Riga (Zeincro & HACRO), for their interest and for going through the selection process. Both had excellent credentials but, unfortunately, EUCROF only had one position available to fill at this time. Hopefully there will be opportunity for more people to get involved in the project in the future.

If you have any questions then 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.

• CTIS Newsletter from EMA

The EMA issued its first Clinical Trials Information System newsletter “CTIS Highlights”, which will be published twice a year. The newsletter will provide you with insights on the development of CTIS. The EMA believes that the information it provides will be interesting and useful for your work.

For more information click HERE.

• Launch of public consultation on joint network strategy to 2025

EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation. The draft strategy details how the European medicines agencies' network can continue to enable the supply of safe and effective medicines that meet patients' needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.

The European Medicines Agencies Network Strategy to 2025, which builds on the HMA/EMA strategy to 2020, outlines six priority areas for the network:

• the availability and accessibility of medicines;
• data analytics, digital tools and digital transformation;
• innovation;
• antimicrobial resistance and other emerging health threats;
• supply chain challenges; and
• the sustainability of the network and operational excellence.

It identifies high-level goals and supporting recommendations for each of these areas, which will guide and shape the detailed work plans of EMA and the national competent authorities in EU Member States in the coming five years.

Input on the draft strategy document is welcome from all stakeholders, including members of the public, until 4 September 2020 via an online questionnaire. Click HERE.

The EUCROF Executive Board believes it is important that EUCROF comments such joint network strategy. To this aim, it is seeking 1 or 2 volunteers to work with the EB to prepare such comments.

If interested, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

• EMA consultation: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Q&A

The European Medicines Agency has published for public consultation the ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers.

Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for DNA reactive (mutagenic) impurities has given rise to requests for clarification relating to the assessment and control of DNA reactive (mutagenic) impurities.

This Question and Answer (Q&A) document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorisation applications and/or Master Files.

Click HERE for more information.

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 3 October 2020.

• EMA communication: "Human Medicines Highlights" Newsletter - June 2020 issue

We are pleased to send you the latest edition of the monthly "Human Medicines Highlights" Newsletter, which includes decisions by 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.

• European Commission consults on roadmap to pharmaceutical reforms

On 3 June 2020, the European Commission published the roadmap to pharmaceutical reforms. See LINK.

The Commission says the strategy will explore both legislative and non-legislative actions and areas for EU investment and could include a review of orphan and paediatric medicines regulations.

A comment from RAPS (see LINK).

The EUCROF Events & Training Working Group is happy to share with all of you the first EUCROF podcast "Risk Based and Remote Monitoring" prepared by Goran Vesov and Ana Stojkovic, both from Optimapharm, as members of the EUCROF Events & Training WG, who held a successful webinar for EUCROF in July 2019 and they comment on the developments of this hot topic, which are taking place at present. The first EUCROF podcast can be viewed on the Latest News section on our website.

We would be happy if you wish to share the info with your contacts.

Further such Podcast will be released in the coming months and our thanks to the Events & Training WG for its efforts in proposing this important new form of communication.