Clinical trials are unique, each with their own protocol, parameters, participants and therapeutic areas. They can differ greatly, covering a range of treatment and study types, and subject to different local regulations and cultural factors. So how do you know what defines clinical trial success in Europe?
With more than 20 years of experience of working with biotech, pharma and medical devices companies to drive their clinical studies, at Siron Clinical we have gathered valuable knowledge about what success means.
In our downloadable RFI, we share some of the insights we’ve gained into how you can make your clinical trial successful in Europe. Here are three of the lessons we share in the RFI.
You could have airtight plans backed up by the latest tech, but what will really make the difference is the people working on your trial. Success comes down to the experience and engagement of the people involved – do they know what they’re doing? And can they communicate that with each other, and with participants and other partners?
At Siron Clinical, our team of more than 35 Clinical Research Professionals are experienced in a range of areas, including orphan diseases and oncology, and our CRAs each have at least 15 years’ experience in clinical research. They are also ICH-GCP accredited.
Our experience has proven to be key to our success in European clinical trials. Through active engagement, we integrate our experience into the teams we form when we work with biotech clients, ensuring a successful outcome.
Local Knowledge Matters
In Europe there is a plethora of national and regional regulations in addition to EMA rules that apply to the continent. Being in compliance with the relevant regulations is vital for a successful trial.
What sets Siron Clinical apart is our CRAs’ extensive local knowledge. They know what local and international regulations our clients need to adhere to for various aspects of their trials. And for non-EU companies running trials in Europe, we can assure them their studies are compliant.
Quality is Key
The quality of data and processes makes a significant difference – quality in means quality out. Quality penetrates every aspect of a trial: project management, medical monitoring, quality assurance, and regulatory submission.
As a member of ACRON – the Association of CROs in the Netherlands – quality is central for us at Siron Clinical. Our highly skilled and experienced team members bring a human quality to data in every service we deliver, and our hands-on approach has led to many long-standing client relationships.
Find out More about Clinical Trial Success in Europe
We provide advice and guidance to biotechs to enable them to navigate the complex regulatory structure in Europe. We have encountered and overcome your challenges, and our experts can help you reach a successful outcome.
For more insights into what defines success in European clinical trials, and to find out more about how Siron Clinical can help you run a successful trial, download the RFI.