Swiss Regulatory Affairs
Swiss Clinical Trial Organisation (SCTO)
The Swiss Clinical Trial Organisation (SCTO) provides tools and expertise for clinical research professionals in Switzerland, focusing on regulatory affairs, data management, and project management.
The Swiss Clinical Trial Organisation (SCTO) is a nationwide network of interconnected platforms offering innovative tools and dynamic approaches for clinical research professionals. These tools are developed by experts across Switzerland in key fields, including regulatory affairs, data management, and project management, facilitating the smooth conduct of clinical study projects. The SCTO Platforms serve as pools of expertise, developing high-quality resources tailored to Swiss laws but adaptable worldwide. They aim to advance academic clinical research in Switzerland by fostering knowledge exchange and sharing best practices. The organisation is funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation, with over 250 people working within its network.
About
**Who they are**
Swiss Regulatory Affairs, operating as the Swiss Clinical Trial Organisation (SCTO), is a research infrastructure of national importance in Switzerland, established to support clinical research professionals. They facilitate knowledge exchange and provide resources to ensure excellence in clinical research across the country.
**Expertise & scope**
* Develops and provides innovative tools and dynamic approaches for clinical research professionals.
* Facilitates the exchange of knowledge, resources, and best practices among experts across Switzerland.
* Focuses on key fields within clinical research, including regulatory affairs, data management, and project management.
* Supports a nationwide network of interconnected platforms comprising experts from university and cantonal hospitals, as well as the Swiss Group for Clinical Cancer Research (SAKK).
* Acts as an incubator for innovation and provides leadership in academic clinical research in Switzerland.
**Reputation / proof points**
* Operates as a research infrastructure of national importance.
* Funded by the State Secretariat for Education, Research and Innovation and the Swiss National Science Foundation.
* Has been offering services to facilitate the smooth conduct of clinical study projects since 2009.
* More than 250 people work within the CTU Network.
Swiss Regulatory Affairs, operating as the Swiss Clinical Trial Organisation (SCTO), is a research infrastructure of national importance in Switzerland, established to support clinical research professionals. They facilitate knowledge exchange and provide resources to ensure excellence in clinical research across the country.
**Expertise & scope**
* Develops and provides innovative tools and dynamic approaches for clinical research professionals.
* Facilitates the exchange of knowledge, resources, and best practices among experts across Switzerland.
* Focuses on key fields within clinical research, including regulatory affairs, data management, and project management.
* Supports a nationwide network of interconnected platforms comprising experts from university and cantonal hospitals, as well as the Swiss Group for Clinical Cancer Research (SAKK).
* Acts as an incubator for innovation and provides leadership in academic clinical research in Switzerland.
**Reputation / proof points**
* Operates as a research infrastructure of national importance.
* Funded by the State Secretariat for Education, Research and Innovation and the Swiss National Science Foundation.
* Has been offering services to facilitate the smooth conduct of clinical study projects since 2009.
* More than 250 people work within the CTU Network.
Additional information
The SCTO Platforms are composed of experts from various clinical trial units across Switzerland. These platforms collaborate to foster innovation and share resources globally. The organisation is funded by national bodies, underscoring its role in advancing clinical research infrastructure. Their services are designed to support the seamless execution of clinical study projects, leveraging a broad network of professionals and institutions.
Key Highlights
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The Swiss Clinical Trial Organisation (SCTO) has been offering services to facilitate clinical study projects since 2009.
Source
“More than 250 people work in the CTU Network, which has successfully been offering services to facilitate the smooth conduct of clinical study projects since 2009.”
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The SCTO is a research infrastructure of national importance in Switzerland.
Source
“The Swiss Clinical Trial Organisation (SCTO) is a research infrastructure of national importance funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation.”
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The organisation comprises a nationwide network of experts from clinical trial units across Switzerland.
Source
“Our platform members are located in clinical trial units at university and cantonal hospitals across Switzerland and the Swiss Group for Clinical Cancer Research (SAKK).”
Certifications & Trust Signals
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The SCTO is funded by the State Secretariat for Education, Research and Innovation and the Swiss National Science Foundation.
Source
“The Swiss Clinical Trial Organisation (SCTO) is a research infrastructure of national importance funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation.”
Buyer Snapshot
Best for
- Clinical research professionals in Switzerland
- Organisations seeking expertise in regulatory affairs, data management, and project management
How engagement typically works
- Collaborative network of experts
- Knowledge and resource sharing
Typical deliverables
- Tools and expertise for clinical research
- Facilitation of knowledge exchange
- Support for regulatory affairs
Good to know
- Best when engaging with clinical research projects within Switzerland.
HQ:
Bern, CH
Languages:
English, German, French
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
6-25
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Swiss Local Contact:
Yes
Vigilance Contact Support:
Yes
Additional ch_rep Details
Device Classes Supported
All device classes (I, IIa, IIb, III) and IVDs
Supports MDR
Implied through IVD support, but not explicitly stated for MDR.
Supports IVDR
Implied through IVD support, but not explicitly stated for IVDR.
Swiss Entity Canton Or Region
Bern
Labeling Support
Yes, implied as part of regulatory affairs for the Swiss market.
Swiss Local Contact
Yes
Vigilance Contact Support
Yes, implied as part of regulatory affairs and CH-REP services.
Can Be Named On Label
Yes, as a CH-REP provider.
