Understanding the clinical trial journey and planning ahead! The Clinical Trial Masterclass provides you with a practical approach to laying the right foundation for your clinical trial. We help you to understand the important links between the many critical areas that will impact your trial. From design, planning and through to trial execution, our experts will discuss key topics for your clinical trial planning. Online workshop on 8 December 2022, 12:00 – 13:00 CET (Amsterdam, Berlin, Paris)

This session provides you with a practical approach to laying the right foundation for your clinical trial. We help you to understand the important links between the many critical areas that will impact your trial. From design, planning and through to trial execution, our experts will discuss:

• The overall clinical trial process and how to effectively plan for the main activities required
• Your obligations according to applicable legislation
• Operational considerations for data collection and management
• Likely challenges to/considerations for operational delivery and discussion of how to select countries and sites for your trial, taking into account your commercial strategy
• Next steps for effective trial planning
• Introductions to trusted providers of complementary services in regulatory affairs, intellectual property law, market access, reimbursement and funding

The workshop is limited to three SMEs and is divided into two sessions. In the first session, the 3 SMEs will receive a 1.5-hour introduction to clinical trials. In the second session, a 1:1 meeting (up to 60 minutes) can be arranged directly after the workshop if participants wish to ask confidential questions. A confidentiality agreement can be exchanged before each 1:1 conversation.

How to apply for services?

• Check your eligibility:
  • Does your company meets the SME definition of the EU?
  • Did your SME receive more than a total of €200.000 of de Minimis state aid between 2020 and 2022? For more information about de-minimis aid. You can find helpful information via these links  de minimis rule and state aid.
• Before you apply, read the full Business Growth Programme description
• Complete application form
• Submit your application and your de minimis self-declaration to WestBIC [email protected] by December 1^st, 2022.

Note: The online training is limited to three SMEs. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for it.

Note: Our services are in general open to SMEs from all over North-West Europe with preference given to SMEs from one of the participating partner regions (see table of partners) for the services offered.

About service provider Afortiori Development

The Afortiori Development team combines extensive industry knowledge with integrity, to design and manage an affordable clinical trial for your product.

Afortiori Development was founded by Dr Nicola Wall and Elizabeth Ralph, who both have extensive experience and a proven track record in global clinical trial management, quality assurance and process management in the healthcare industry. Together, they have built an impressive global team of clinical trial specialists, clinicians and biostatisticians with experience in adult, paediatric and neonatal clinical research, and both primary and secondary healthcare settings.

More information: The online coaching is part of the Interreg NWE-funded Codex4SMEs project. Since 2017, Codex4SMEs has built a large European network in the field of diagnostics and personalized medicine. More than 300 small and medium-sized enterprises have so far benefited from the opportunities offered. These include various events and tailored services that support SMEs in the development of innovative diagnostics.

Discover more about BioRegio STERN Management GmbH:

Based in southwest Germany, BioRegio STERN Management GmbH acts as a business development agency for the regional biotech and life science sector. The primary goal is to anchor the BioRegion STERN and their business throughout Germany and internationally on a high level. An important strategy for the development of the regional cluster is to build on existing strengths. The regions Stuttgart and Tübingen are characterised by a prominent network of biotechnology and medical technology SMEs as well as universities & research institutes and including service provider companies.