At the upcoming 12th Annual Outsourcing in Clinical Trials Nordics meeting, experts from the pharmaceutical, biotechnology and medical device industries, will gather in Copenhagen, Denmark, to provide an in-depth exploration of current trends and challenges in clinical trial operations, outsourcing, and management across two days.
The event features two parallel streams, with one focusing on outsourcing in clinical trials (OCT) and the other dedicated to clinical trial supply (CTS).
The OCT stream of the conference will commence with a talk on recent updates on the EU Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS), providing key insights into the latest regulatory developments as well as learnings and tips on handling clinical trial submissions. One of the initial presentations will focus on the developments in technology and their impact on the transformation of the clinical research landscape.
A key theme of the the OCT stream will be the adoption of a more patient-centric approach and the reshaping of the clinical research landscape by leveraging data and incorporating cutting-edge technologies to improve trial results.
Another central focus of the OCT stream will be outsourcing strategies, featuring presentations on fostering strong vendor partnerships, optimising clinical trial protocols and governance structures as well as strengthening collaborations between sponsors and contract research organisations (CROs). The first day of the conference will end with an overview of the recent global trends in clinical trials and a focus on challenges in drug development for CNS disorders and rare diseases.
The parallel CTS stream will kick off with a presentation on temperature-controlled airfreight, highlighting insights on the specialisation of air cargo management, global training programs and certification processes for logistics operators. During presentations surrounding contract development and manufacturing organisations (CDMOs), topics such as adaptation to new trial designs, adopting patient-centric approaches and maintenance of strong vendor relationships will be discussed. The optimisation of supply chain management through Interactive Response Technology (IRT) and enhancement of patient engagement via gamification will also be covered, emphasising strategies to ensure trial efficiency and retention.
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By GlobalDataKey discussions on the CTS stream in the afternoon will shift to the role of advanced technologies like artificial intelligence (AI) and the management of global supply shortages and the impact of geopolitical trends and events.
Exploring trial strategies on a global level
The second day of the conference will begin with a session on navigating the regulatory landscape for combination trials in the Asia-Pacific region, exploring advantages, challenges, country-specific differences, and updates specific to the APAC region. On this day, the sessions will delve into topics such as regulatory challenges, sustainability, and decentralised clinical trials (DCT).
A significant topic that will be addressed is sustainability in clinical trials, with a spotlight on the healthcare sector’s responsibility to implement best practices to minimise the environmental impact of trials.
Joachim Lovin, a DCT specialist at Novo Nordisk will present a sponsor case study and share insights on implementing decentralised trial elements post-Covid-19, highlighting the evolving state of DCTs, best practices, and tools for improved patient engagement. A fireside chat in the afternoon will explore risk management strategies in clinical trials, highlighting the significance of early feedback and oversight.
The OCT stream of the conference will end with interactive roundtable discussions on clinical supply chain risks, effective engagement with CROs, and DCT trial designs, offering attendees the chance to engage directly with experts and peers to address critical industry challenges.
The CTS stream, running in parallel, will explore the integration of digital technologies and innovations in clinical trials. The day will begin with a case study by Benoit Cuyvers from Clario, discussing the role of AI in clinical development, specifically risk-based (quality) monitoring- demonstrating how AI can identify patterns in data that might be missed by humans, with practical examples from respiratory trials. The CTS schedule will continue with Magnus Jörntén-Karlsson from AstraZeneca presenting the acceleration innovation through digital health technologies, followed by an expert conversation on developing fit-for-purpose digital measures of health with Kai Langel from DEEP Measures and Teske Valk from Novo Nordisk.
The CTS stream will wrap up with a presentation on maintaining data control in outsourced trials, a panel exploring existing and emerging technologies in clinical trials, and roundtable sessions covering risk mitigation, CRO engagement, and the impact of decentralised trial design.
The conference is hosted by Arena International Events Group, a B2B events company owned by GlobalData, the parent company of Clinical Trials Arena and Pharmaceutical Technology.
A detailed agenda for the OCT stream can be found here, while a detailed agenda for the CST stream can be found here
