KLIFO

On 24 July 2024, Simone Ahrens-Mende Director of Data Management and Biostatistics at KLIFO will be hosting the webinar "Ensuring Compliance and Data Integrity in eClinical Systems: Navigating EU Regulatory Frameworks and Best Practices." 👥 The webinar is part of ACDM’s series of “Hot Topics” in Clinical Data Management. It is a great opportunity to stay at the forefront of clinical research and data management, and to gain valuable insights and practical tips from Simone’s extensive 23-year career in clinical research and eClinical systems. 🎯 The webinar will focus on: - Navigating EU regulatory frameworks - Best practices and strategies - Comprehensive compliance approach - Real-world insights 🔗 ACDM members and non-members keen on mastering these critical aspects of Data Management and Biostatistics can join the learning session. Participation requires registration at: ACDM Webinar Registration - https://lnkd.in/epqBzHZc. #DataManagement #eClinicalSystems #DataIntegrity #ACDM #KLIFO

We are very happy with our membership of the Federal Association of Contract Research Organisations (BVMA). Today, we've been featured in their series of "Get to know our members"... 😀

Christmas in July… 🎄 Well, at least for our Office Manager Mette Widén 😄 Although the sun is shining from a clear blue sky, birds are singing from the tree tops and flowers in all colours are blooming everywhere, Mette has been remarkably quiet and secretive these past few days... Why? Because this is the time of the year she decides on the gifts that will be part of our Christmas gift shop 🎁👏 . Few of us know about the visit to the Common Sense & Sport Direct Herlev showroom, and the "Idea List" itself is “strictly confidential”. No matter how hard we try, there is no way to get her to spill the beans. So… as always, we will just have to wait until the Christmas shop opens later this year. But what we do know is this: Every year, Mette prepares a great gift shop for us making it very difficult to choose a Christmas gift – thank you for thinking about Christmas in July, Mette 🙏🎄 #MerryChristmas #HappySummer #KLIFO

How we work with sample size calculations? We’ve asked our colleague Senior Biostatistician Patrick Dubovy to explain his four-step approach to ensure accuracy and valid data… “I'm excited to showcase my meticulous approach to sample size calculation, a cornerstone of robust clinical trial design. Proper sample size determination is vital to ensure that a trial has the statistical power to detect meaningful effects while optimizing resource utilization. With over 14 years of experience spanning phase 1 through 4 trials, I bring a wealth of knowledge and expertise to this critical aspect of study planning. Here's is my four-step approach to ensuring precision and reliability: ✔ Understanding Your Study: My process begins with a detailed discussion of your study objectives and design during a kick-off meeting. I gather essential information such as expected means, standard deviations, drop-out rates, and statistical methods to tailor my approach to your specific needs. ✔ Simulations and Quality Control: In cases where certain parameters are unavailable, I conduct simulations to accurately estimate them. Throughout the process, I perform rigorous quality control checks to ensure the accuracy and reliability of the calculations. ✔ Literature Reviews: I conduct thorough literature reviews to support the assumptions and estimates used in my calculations, ensuring the validity of my approach. ✔ Comprehensive Reporting: The final deliverable is a comprehensive Sample Size Calculation report, summarizing the methodology, assumptions, and the recommended sample size for your study. My aim is to provide our clients with a well-justified and reliable sample size calculation to support their trial's success.” Feel free to reach out to learn how KLIFO’s detailed approach to sample size calculation can enhance the robustness and validity of your clinical trials 📧🤝 #Biostatistics #ClinicalTrials #SampleSizeCalculation #ResearchDesign #StatisticalPower

What would you choose – to go first or last? Well, the route was set, but we were happy to be the first stop on Fuglebakken’s very first Tour de Chambre on Friday afternoon 😀 The finalisation of the Fuglebakken office community for companies working in life science and greentech has been delayed once more, and the location is still under construction. But looking at the bright side, this entrepreneurial atmosphere kind of brings everyone closer together, and nothing could stop the organisers kicking off the first Tour de Chambre 🎉🥂 First stop after the official welcome was KLIFO’s office, and Rasmus, Alejandra, Hanne and Christina were indeed ready to welcome neighbours and co-workers to an afternoon snack, a glass of champagne and a brief introduction to KLIFO’s integrated solutions across the drug development journey. Afterwards, it was such a pleasure to visit our co-workers and learn more about their businesses too. Once the entire location is “spick and span” and ready to greet visitors, we do indeed look forward to welcoming clients, partners and friends to a proper housewarming 😀 Please feel free to reach out if you need strategic advice or operational support for your drug development project. #DrugDevelopment #StrategicAdvice #OperationalSupport #KLIFO

First visit to our new Clinical Trial Supply location – and greeted by Sally’s On Wheels… What’s not to like 😀 A week ago, the entire Glostrup office was invited to visit KLIFO's new CTS location. We all know that first impressions matter, and Henrik schmidt Jensen, Facility Manager and responsible for establishment of the new facility and Christina Vinum, VP Clinical Trial Supply Solutions did indeed make sure we got a great first impression of the new premises. The new location will triple the size of our CTS facilities and quadruple our storage and production capacities. Once ready, we will have a cutting-edge storage and CTS production facility for clients across the pharmaceutical and biotech industries. Henrik and Christina were great tour guides making sure that we could all see the huge potential, our Abildager location has to offer once ready in 2025. And then there was Sally’s – ready to serve just the kind of lunch you crave on a great field trip: Burgers and milkshakes 😀 If you want to learn more about our CTS expansion, feel free to reach out to Simon Bendix Hørup Nord, Commercial Director CTS or Christina Vinum. #DrugDevelopment #CTS #KLIFO

M7 secures 10-year lease with KLIFO A/S, fully letting c. 6,500 sq m warehouse near Copenhagen, Denmark

Approval of submissions are often delayed due to inadequate CMC documentation… but what is “adequate” documentation? We have this discussion with many of our clients, and we always highlight that: ❗ Relevant authorities require robust CMC documentation demonstrating high quality and compliance at every stage of a drug development project BEFORE allowing progress to the next development stage. A project can be put on clinical hold if the CMC documentation is inadequate. ❗ The required level of documentation DEPENDS on whether you are at the pre-clinical stage, in clinical development or ultimately applying for a licence to commercialise. Differences in the required CMC documentation at each stage are substantial. ❗ CMC milestones and activities must be closely ALIGNED with regulatory authority interactions and the overall non-clinical and clinical development programme to ensure adequate CMC documentation for submission and availability of drug product for clinical trials and for commercialisation. Ultimately, providing adequate CMC documentation will mitigate risk and ensure efficient progress of a development project. If you want more insights on CMC deficiencies, try taking a look at these interesting reports: 📖 Report by the European Medicines Agency (EMA) stating that as many as 25% of the 66 MAAs submitted to the EMA by small- and medium-sized enterprises during the period 2011-2015 were rejected due to critical documentation lacking in their applications (Amaouche et al. (2018) - link in Comments). 📖 Report from the FDA on the quality of Investigational New Drug applications (INDs) within oncology highlighting that up to 40% of submitted Investigational New Drug Applications do not pass the review due to quality documentation deficiencies (Manning et al. (2020) - link in Comments). Feel free to reach out to Hanne Wulff Nielsen VP CMC Development Solutions to discuss how to avoid CMC documentation pitfalls. #DrugDevelopment #CMC #KLIFO

Challenge: Emerging biotech companies need an easy-to-use Electronic Document Management System (EDMS)… Challenge accepted💡 💻 ❕ Numerous excellent EDMS software solutions are available, and emerging biotech companies are almost spoiled for choice. However, navigating the landscape of EDMS systems catering for different needs can be challenging for a small emerging biotech company on the lookout for a simple, user-friendly EDMS that guarantees compliance with GxP regulations and streamlines processes. Anders Reinholdt Thunell is Senior System & Document Control Specialist here at KLIFO, and he set out to design a user-friendly and compliant EDMS solution based on Veeva Vault tailored specifically for the needs of biotech companies. The solution should enhance the value for emerging biotech companies by ensuring complete control and easy retrieval of documents. Other specific requirements for a suitable solution were that it should: 👉 Include classifications and metadata to support biotech EDMS needs 👉 Be fully GxP compliant and 21 CFR Part 11 compliant for eSignatures 👉 Facilitate Due Diligence processes 👉 Support content migration to another Veeva Vault, if and when relevant In the fall of 2023, we were ready to offer our “plug and play” Veeva Vault/KLIFO Biotech EDMS solution to our first clients. It is a solution that targets small biotech companies, and KLIFO takes care of system maintenance, Veeva General Releases, and manages user administration on behalf of our clients😀 If you want to learn more about our biotech EDMS solution, feel free to reach out to Anders or to one of his colleagues in Regulatory Affairs Solutions. #EDMS #biotech #Veeva #Drugdevelopment

⭐️ Today, KLIFO has announced a strategic investment that will expand our Clinical Trial Supply capacity significantly. We are scaling up our CTS solutions capacity to keep pace with the thriving demand for efficient, flexible biotech and pharma facilities in the Nordics and Northern Europe. Our new facility, located in the Medicon Valley life science cluster, will open in mid-2025. It positions KLIFO to: ✔ Manage future demand for flexible CTS facilities ✔ Implement new technologies to provide our tailor-made, flexible solutions ✔ Minimise our environmental footprint Rasmus Nelund, KLIFO’s CEO, says: “We are laying a robust foundation for the future, cementing our position as the integrated drug development consultancy in the Nordics and gearing up to service strong anticipated demand for flexible, efficient and convenient CTS solutions.” Read the press release here: https://lnkd.in/dxn2AC_G. #KLIFO #ClinicalTrialSupply #MediconValley #GMPcertified