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Optimizing outsourcing in the Nordics

Jane Tidemand, Clinical Trial Office in Denmark

Outsourcing in Clinical Trials Nordic in Copenhagen, 9 – 10 of September 2015, offered a stronger presence from both the pharmaceutical and medical device industries.

The event has established itself as the leading clinical outsourcing-specific event in the Nordic countries and now returned for its 3rd year to Copenhagen. The Outsourcing in Clinical Trials Nordic aimed to deliver cutting edge information directly from the industry decision makers through a mixture of CEOs, Chief Medical Officers and Clinical Directors in the line-up. This year the event offered a stronger presence from both the pharmaceutical and medical device industries. The meeting also featured several high-level speakers from some of the industry’s leading companies, using outsourcing examples from their own experiences of clinical development, including pharmaceutical, medical devices and biomedical research. The event featured presentations, interactive roundtables and panel discussions, as well as networking opportunities with industry peers.

Challenges for the industry

This year’s event carried on the success from last year’s conference and continued to highlight and overcome the current challenges within clinical outsourcing and medical device-related issues; budgeting and contracting, improved vendor communication strategies, and patient recruitment, for example.

Key topics for this year’s event included CRO selection techniques, alternative outsourcing models and a look at new trailing sites available for both pharmaceutical and medical device candidates. Other topics were academic research into medical devices and helping companies transition to clinical trials. This year the Single Point of Entry Group was onboard to discuss their free consultation service available for the biotech and the medical device industries.

Discussing new regulations

EU regulation 536 and its impact was also discussed. The new clinical trials legislation, which was adopted on April 16 2014, will ensure that the rules for conducting clinical trials are identical throughout the EU. The regulations will become fully implemented next year and will increase the speed of trial set-ups, and at the same time outline the necessary changes companies will need to implement in their application process. Karin Markensen from the Danish Health and Medicines Authority gave a talk on the implications of the new regulation for pharma and biotech companies.

Photo of Jane Tidemand, Clinical Trial Office, who spoke at OCT Nordics