Online-Event | Understanding the clinical trial journey and planning ahead
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.
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.
Submit your application and your de minimis self-declaration to WestBIC codex4smes@westbic.ie by December 1st, 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.