So far, a total of 1,243 clinical trials have been transferred to the CTIS!
April 2024

Last week ANSM, the French Competent Authority send out CTIS transition forms to be completed by the sponsors. It's a good step to ensure all CTIS transferred studies are approved before the deadline, especially considering that the summer holiday period is not too far away.

Also last Monday, EMA released a CTIS newsflash in which the
Sponsors are reminder to transition any trials that are expected to continue after 30 January 2025 from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR). Sponsors should take into account the time necessary for completion of the Member State(s) evaluation procedure, which can take up to 3 months. When possible, Members States have agreed on an expedited procedure for transitioning trials to the CTR.

Some interesting CTIS facts:
- So far, a total of 1,243 clinical trials have been transferred to the CTIS (data from 15th April)
- the number of the applications in the week of 15th April increased by 20% comparing to the week before.
- Competent Authorities with a highest number of CTA/CTIS transition decisions issued in the week of 15th April were Denmark and Spain

AnRes Clinical team has experience with transferring trials into the CTIS, so for any questions related to the process, please do not hesitate to get in touch with us.

"the devil is in the detail"..

How do you ensure your pivotal study data is reliable?

At AnRes Clinical, we recognize the associated challenges with making sure clinical data is robust and supports the reliable outcomes of clinical trials. That's why we're amplifying our Monitoring Oversight team with seasoned experts, each boasting 20-30 years of clinical trial experience, now extending to Europe and the United States.

Our Monitoring Oversight Experts offer:
✅Laser-focused insights into critical data points for robust pivotal trials
✅Extensive oversight on behalf of sponsors
✅Decades of hands-on experience in clinical monitoring and project management
✅Therapeutic proficiency in challenging-to-recruit indications: Oncology, Rare Diseases, Autoimmune, and Neurology
✅Proven track record in auditing and regulatory inspection preparation with a quality-centric, pragmatic approach

The old saying "the devil is in the detail" refers to difficulties resulting from the unforeseen nature of unexamined details. Our experts focus on those study details that matter when it comes to the data contributing to the primary endpoints while maintaining a big picture coming from their experience of both leading clinical trial teams as well as participating in multiple regulatory inspections. For a Sponsor, it is critical to understand how the "little detail" can determine the clinical trial outcome and have impact on the patient´s safety and well-being.

Currently operational in Denmark, Sweden, Norway, France, Spain, Italy, Germany, Poland, Czech Republic, the UK and the United States. Our mission is to capture the uncertainties surrounding data quality and protocol compliance, ensuring consistent, high-quality clinical monitoring.

Partner with us to seize control of your trials' success and confidently demonstrate sponsor oversight. Let's navigate through those challenges together! 💡💊

Really proud that AnRes Clinical´s extended team of Regulatory Experts has just submitted a Scientific Advice briefing package to EMA on behalf of our client who is addressing a significant unmet need.

It was a concerted effort of dedicated team members providing the necessary regulatory and medical expertise to ensure clarity on the positioning and the strategy supported by evidence from clinical trials and publicly available scientific resources. We believe the Scientific Advice with EMA will represent a significant step in this product development journey.

On the Rare disease day 2024,

we would like to take this moment to thank and appreciate physicians who tirelessly help their rare disease patients with the challenges those patients and their families are facing with obtaining a clear diagnosis, getting interdisciplinary support and looking for potential treatment options.
At AnRes Clinical we have been supporting rare disease patients through the clinical trials we have been involved in. We closely work with the physicians and study coordinators in order to minimise unnecessary burden to patients in the clinical trials we are responsible for. We have established strong relationships with site team members, so many challenges can be solved in an efficient way.

So far, AnRes Clinical we have been supporting a number of clinical trials in patients with rare diseases:
•Rare forms of cancer (Phase 1/2 and Phase 2 studies)
•Amyotrophic Lateral Sclerosis (ALS) (Phase 3)
•Rare form of epilepsy (Phase 2)
•Transfusion dependent Beta-thalassemia (gene therapy)
•Congenital Hyperinsulinism (Phase 2)
•Paroxysmal Nocturnal Haemoglobinuria (Phase 3)
•Congenital Disorders of Glycosylation (RWE)

Did you know that your ongoing clinical trial needs to be assessed again when transferred to the CTIS?

February 2024

The transition to the CTIS is mandatory for all clinical trials expected to be completed after 30 January 2025 and the evaluation of those trials needs to happen before that date, so sufficient time should be allowed for the assessment by the Member States where the trial is taking place.

Clinical Trial Applications to be transitioned have already been authorised under the Clinical Trials Directive, therefore Member States Concerned (MSCs) may choose to authorise Transitional trials within or in less than 60 days. However, MSCs can create Requests for Information (RFIs) on the transitional application, if necessary (leading to a maximum period of 106 days, or further in the case of some types of Investigational Medicinal Products).
The evaluation process of a transitional trial includes the same three main phases as any other application submitted under the Clinical Trial Regulation, i.e.: Validation, Assessment, and Decision.

The study protocol submitted needs to be harmonised across the Member States.

At AnRes Clinical we have the expertise of transitioning clinical trials to CTIS. Please do not hesitate to get in touch if you would like to know more.

In 2023 at AnRes Clinical we have been supporting 17 clients!

Moreover, we have:
🤝 Been successfully providing oversight and monitoring of clinical trials in chronic and rare neurology, auto-immune and oncology conditions. We also provided strategic insights through deep-dive regulatory strategic mapping in order to de-risk clinical development of our clients´ products.
🚀Exceeded our goals for last year by gaining five new biotech clients in 2023.
📅Actively participated in industry events such as the Nordic Life Science Days, “a Nordic festival of life science” where we met with our current partners, friends and hopefully future clients.

🎤Been featured on a prominent Life Science Talent Talks, sharing insights into clinical research, the motivation behind starting AnRes Clinical, and offering advice for aspiring independent experts.

🔬Become a proud partner of the Oncology Development Program 2 by Lean Life Science — fostering early-stage health and life science innovation where we supported two finalists of the program in their drug development needs.

🌍Collaborated with various organisations, from biotech companies to academic institutions and hospitals fostering a culture of innovation and knowledge exchange.

With a clear vision of a bright future ahead, we look forward to continuing our mission of working together on developing new treatments for chronic and life-threatening diseases.

Thank you for following our journey!

Team at AnRes Clinical

Meet us at the largest life science partnering event in the Nordics!

November 2023

We're thrilled to announce that our CEO, Anna Polak-Andersen, and our dedicated team member, Mette Hansenholt, will be attending the 10th Nordic Life Science Days 2023 in Copenhagen,

on 29-30th November 2023.

The NLSDays is a groundbreaking event that brings together the best in the life science industry.

It highlights success stories from the Nordic life science companies, emphasizes the importance of licensing deals and business strategies during the tough financial climate, and discusses the necessary building blocks for a successful life science sector.
Last year, NLSDays achieved remarkable milestones, gathering 1540 delegates from 32 countries, facilitating over 3,000 face-to-face meetings, and showcasing 135 cutting-edge companies.

You can still register at: https://lnkd.in/d5TT8sX

At AnRes Clinical, we're all about fostering innovation and driving positive change in the world of clinical research. We're looking forward to connecting with fellow industry leaders, exploring potential collaborations, and learning from the incredible success stories that

NLSDays has to offer.

Stay tuned for updates from the event, and let's explore new avenues of possibility together!

We are excited to introduce Mette Hansenholt, M. Scient. Med., the newest addition to the AnRes Clinical team.
7th June 2023

Mette has two years of experience working in global CRO in clinical start-up Delivery.

She has worked in all Nordic countries, mainly with clinical studies within rare diseases.

Her primary tasks were to be the bridging person between sites and sponsor, QC of documents, Keeping the overview of the study process and making sure timelines were reached.

She holds a MSc. Medicine from Aalborg University specialized within Translational Medicine. Mette is passionate about closing the gap between the scientific and operational aspects of drug development projects and also has the mindset needed to advance projects run by biotech with a lean approach.

We look forward to the valuable contributions she will make to our team. Welcome, Mette!

Life Science Talent Talks

1st June 2023

Thank you to Søren Spanner Bachand Nehar Mortuza at Life Science Talent Talks Podcast for having me at the Networking Event & Season 1 Celebration with Podcast Guests.

It was really great to be able to answer questions from the podcast audience just live sitting together with them at the guest table face to face. It was also a fantastic opportunity to ask directly other company founders about their journeys. We all had lots of fun due to the great energy floating around and the friendly atmosphere.

I would like to invite you to listen to my episode, along with previous podcast episodes, here. In my episode (S1E15), I had the pleasure of sharing my experiences in clinical research, the motivation behind starting my own consultancy firm, and offering advice to those aspiring to become independent experts in their field.

Sincerely,
CEO, founder of AnRes Clinical Anna Polak-Andersen

AnRes Clinical have joined the Oncology Development Program 2 (ODP2) as a partner service provider.

ODP2 is organised by Lean Life Science, which has been now selected by InnovateUK to deliver its oncology accelerator to support the development of early-stage health and life science innovation in the UK.

ODP2 uses a proven approach that has seen attendees of ODP1 secure over £50 million in funding to date. ODP2 is open now to UK-based academic and early-stage companies with any therapeutic modality, diagnostic, digital, health or med tech oncology-focused innovation.

Selected by independent expert assessors, the nominated innovators will present to an expert panel who will choose eight projects to join the programme on the 5 June.

The final eight will receive dedicated non-dilutive funding to develop their project plans and pitch decks. This is combined with hands-on support from world-recognised business innovation tools instructors, oncology industry experts, investors, a unique network of leading contract research organisations, and feedback directly from industry partners.

We wish you and your family a Merry Christmas as well as a successful and fulfilling New Year 2023!

Another year is coming to an end, and our thoughts turn to all of you who have trusted in us and who we have been collaborating with us, exchanging thoughts and networking this year.

We would like to thank our clients and partner collaborators and we are sending you our warmest gratitude for the opportunity to contribute to closing gaps in unmet therapeutic needs for patients suffering from long-term and serious conditions. We are very happy we could help with global clinical trial management, clinical monitoring in Scandinavia, medical writing in Oncology, regulatory advice for pharmaceuticals and medical devices, private investor funding, data management and statistical analysis needs this year.

Another day at AnRes Clinical...

18th October 2022

This morning we had a visit from Lars Løkke Rasmussen,

the ex Danish Prime Minister, at AI Innovation House where our office is located. In fact, him and his political party Moderaterne want to improve the environment for start-up companies by implementing new investment structures and lower the income tax associated with owning company shares.

We like the sound of that.

Nordic Innovation Fair

27th September 2022

What a great opportunity to meet entrepreneurs from the Nordic Research Institutions and hear about their innovative projects and journeys from idea to biotech start-up. It will be interesting to further explore potential collaborations and support the next steps toward first-in-human clinical trials.

Thank you to the organizer and the Novo Nordic foundation for an inspiring day.

With kind regards

Clinical Project Delivery Manager

Cecilie Abildgaard