Danish Biotech Spring Gala 

June 2024

Our Mette Hansenholt is attending this year´s Danish Biotech Spring Gala at the Danish National Museum.

She is looking forward to an evening with celebration and great company in this wonderful and historical building.

CTCG Clinical Trials Coordination Group Recommendations related to contraception and pregnancy testing in clinical trials Version 1.2 dated 7th March 2024 is out.

June 2024

It´s mandatory to consult when developing a clinical trial protocol or master Informed Consent Form.

https://lnkd.in/eKnFKUGg

Key changes in comparison to the previous version are in Section 1.2:
Definition of end of relevant systemic exposure: with reference to the SWP/NcWP recommendations an example for “end of relevant systemic exposure” as five half-lives after end of dosing and for encapsulated compounds five half-lives of the free fraction after complete release or elimination from the encapsulating body has been added. In addition, for genotoxic compounds a reference to the practical approach how to deal with the five half-lives after end of treatment and in addition to the recommended time for contraception as given in the SWP/NcWP recommendations has been added.

Congratulations to Mette for one year at AnRes Clinical!!!
June 2024

It has been so incredible to have you on board for the last year which felt so much longer, so many things have happened since the initial trip to Norway in June 2023. Once again, we are so grateful for your fantastic work, diligence, perseverance, business acumen and the amazing ability to build long lasting relationships. You are also one of the most positive persons ever!

Thank you for our one year together and thank you for the difference you make when tirelessly supporting the development of new therapies in life-threatening and chronic diseases at AnRes Clinical

Monitoring oversight.. here are the three highlights, from recent monitoring oversight visits performed by AnRes Clinical monitoring experts
May 2024

1. This week we made one of our clients very happy when we told them that the quality of the source data at one of their top patient recruiting site is really good. It feels when you as the sponsor are reassured that your clinical trial data is handled with care by both Investigator sites and the CRO CRAs, especially when it to the data that will directly support regulatory applications with the FDA and EMA.

2. Monitoring Oversight Visit is an opportunity to look into the challenges of the trial itself and recognise the effort that both Investigator and CRO teams are putting into its success. This means not only looking at the risk areas but it’s also a chance to receive positive feedback. The observations from one of your oversight monitoring visit last week led to the sponsor acknowledging the hard work of the CRO CRA. Being a CRA remains one of the toughest jobs in the clinical research industry. Kudos to all the CRA traveling warriors out there!

3. Identified deficiencies can make you even more prepared for a regulatory inspection which is no joke for a product heading for a regulatory approval.

Let’s make your trial immune to receiving an FDA Form 483!

"Anything worth having takes time"..

Happy Clinical Trials Day!
May 2024

Yesterday, we celebrated the 2. Day of Pentecost in Denmark.

Along with that, we celebrated the crucial role of well-conducted clinical trials in advancing healthcare. These trials pave the way for groundbreaking treatments and better health for all. Here's to the dedicated professionals ensuring thorough and ethical research!

Breakthroughs in Cancer Treatment: Highlights from the Oncology Network Meeting

May 2024

A great thanks to Medicon Valley Alliance for the well-arranged Oncology network meeting yesterday in Malmø.

The invited speakers covered both the historical treatment of lung cancer, specifically Non-Small Cell Lung Cancer (NSCLC), and promising new treatments currently in clinical trials.

Jens Benn Sørensen has contributed to NSCLC treatment development for over 30 years. He highlighted the increase in overall survival for NSCLC patients from 2-5 months in the 1970s to an average of 42 months today, thanks to advancements in targeted treatments, surgery, and genetic insights.

Martin Avander from Daiichi Sankyo discussed the benefits of Antibody Drug Conjugates (ADCs). When combined with chemotherapy, ADCs target tumor areas, extending drug exposure from 5-10 hours to up to 5 days, enhancing treatment effectiveness.

Another promising therapy is IO Biotech immune-modulating vaccine, which boosts T-cell activation to attack specific immune cells, thereby improving the Tumor Immune Microenvironment (TME).

Thanks to all speakers for their insightful presentations and efforts in advancing cancer treatment and improving patient survival rates.

Anna Polak-Andersen, AnRes Clinical

Mette and Anna are attending the Medicon Valley Alliance Oncology Network Meeting in Malmö.

May 2024

This session topic are Insights and Innovations in Lung Cancer Management. With AnRes Clinical currently supporting a client who was very recently granted a priority review by the FDA for their compound offering a breakthrough therapy to Non-small cell lung cancer (NSCLC) patients, we are eagerly awaiting the presentations by:

- Prof. Jens Benn Sørensen from Rigshospitalet in Copenhagen
- Ayako Wakatsuki Pedersen, VP Translational Research at IO Biotech
- Martin Avander, Medical Manager at Daiichi Sankyo Europe GmbH
- Lars Ringgaard, Disease area specialist oncology portfolio, Nordics at AstraZeneca.

Say hello to us if you are also coming to this day packed with interesting talks about what's the latest in lung cancer treatment, again beautifully organised by Medicon Valley Alliance.

Our CEO, Anna Polak-Andersen has been invited to the Advisor Network at CPHLabs.

April 2024

With CPHLabs creating laboratory work spaces for scientists, research teams and startups, the Advisor Network provides a wonderful opportunity to take the collaboration even further.

Anna has offered her expertise in clinical trials and regulatory interactions which she hopes will be helpful to start-ups aiming to develop their pharmaceutical products.

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.