Training and Consultancy Services
Embark on your journey into clinical trials in Europe with confidence, especially if you're new to the Clinical Trial Information System (CTIS). I offer top-level insights, providing a comprehensive overview of how clinical trials function in Europe. From high-level information to in-depth submission strategies, I guide you through the intricacies of setting up clinical studies in the EU.
Expertise for Companies Outside the EU
I specialize in supporting companies from outside the EU looking to enter the European market and navigate the complexities of successful Clinical Trial Applications (CTAs). Whether you are a seasoned organization or a young professional, I provide tailored guidance to ensure a smooth and successful entry into the EU market.
Including Transitional Trials from CTD to CTR
My consultancy services cover various aspects, including the transition of trials from the Clinical Trials Directive (CTD) into the Clinical Trial Regulation (CTR). I offer expertise in managing these transitional trials, ensuring a seamless adaptation and compliance with the new regulatory framework.
Constantly Changing Environment Expertise
Navigating the constantly changing regulatory landscape can be challenging. With a keen eye on evolving requirements, I provide expert advice, ensuring you set everything up right the first time. My consultancy services cover Study Start-Up in Europe, clinical trials, CTIS implementation, and the development of SOPs and working instructions.
Long-Term and Short-Term Support
Whether you need guidance at the beginning, middle, or end of your clinical trial journey, I offer flexible long-term consultancy services. I can accompany you throughout the entire process, providing support from initiation to completion. Alternatively, opt for short-term assistance when nearing submission – I can conduct quality checks to prevent potential delays.
Why Choose My Consultancy Services?
- Expertise in Study Start-Up in Europe.
- In-depth knowledge of clinical trials and CTIS.
- Implementation of SOPs and working instructions.
- Strategic guidance for successful submissions.
- Specialized support for companies outside the EU entering the European market, including transitional trials from CTD into CTR.
Ready to streamline your clinical trial processes and ensure compliance from the start?
Contact me to discuss your specific needs and create a customized plan that fits your requirements.