Connecting research initiators and healthcare centres
NEFRO-NL provides a central point of access for sponsors, contract research organisations and other research initiators seeking to conduct nephrology research in the Netherlands.
Through our national network, we support an efficient and transparent process from initial contact to scientific review and site selection.
Central access
A single point of contact for initiating clinical research within the Dutch nephrology research network.
Expert review
Scientific and feasibility assessment by the NEFRO-NL Board and relevant working groups.
Network coordination
Structured communication and coordination between sponsors, CROs, NEFRO-NL and participating sites.
New clinical trial evaluation and site selection process
PHASE 1
Initial contact and agreements
Receipt of initial study request
The process begins when a sponsor or CRO submits an initial request to NEFRO-NL regarding a potential new clinical trial.Introduction meeting
An introductory meeting is organised between the sponsor or CRO and NEFRO-NL to discuss the potential collaboration, study objectives and anticipated timelines.Confidentiality agreement (CDA)
A confidentiality agreement is reviewed and executed by the relevant parties before confidential study information is exchanged.
Either the sponsor/CRO CDA template or the NEFRO-NL CDA template may be used.
Service agreement
The NEFRO-NL service agreement template is shared with the sponsor for review.
Preferably, the agreement is executed before the scientific and feasibility review begins in step 6.
PHASE 2
Study evaluation
Sharing of study documentation
Following execution of the CDA, the sponsor provides NEFRO-NL with the study documentation and information required for evaluation.
- The study synopsis and/or protocol
- The expected number of participating sites
- The expected number of patients per site
Scientific and feasibility review
The study protocol and supporting documentation are reviewed by the NEFRO-NL Board and the relevant NEFRO-NL working group or working groups.- The scientific relevance of the study
- The feasibility of conducting the study within the NEFRO-NL network
- Alignment with NEFRO-NL’s scope, objectives and expertise
The final decision is shared with the sponsor within two weeks of the relevant study information being provided to the NEFRO-NL Board and working group(s).
PHASE 3
Site feasibility and selection
Board approval and site feasibility assessment
If the study is approved by the NEFRO-NL Board, the site feasibility process is initiated.
Participating sites are invited to assess the study and confirm their interest and capability to participate.
Participating sites provide their feedback within two weeks of receiving all relevant study documentation.
Site selection recommendation by NEFRO-NL
Based on the feasibility responses received, NEFRO-NL prepares and shares a recommended site list with the sponsor. Where applicable, the recommendation also includes backup sites.The recommended site list is provided to the sponsor within two weeks of initiation of the site feasibility process.
If consultation with the NEFRO-NL Site Selection Committee is required, one additional week may be needed to complete the recommendation.
Site selection decision by the sponsor
The sponsor reviews the recommended site list and makes the final decision regarding the sites to be invited for Site Qualification Visits (SQVs). The final selection of sites is subsequently shared with NEFRO-NL.Support throughout study initiation and conduct
NEFRO-NL supports a structured and transparent process from initial study request through scientific review and site selection.
By coordinating communication between the sponsor or CRO, the NEFRO-NL Board, working groups and participating sites, we help create a clear and efficient route towards the final site selection decision.
Where applicable, NEFRO-NL can remain involved during study initiation and conduct to support communication, coordination and progress across the participating network.
Contact NEFRO-NL
Nephrology Research Organization Netherlands (NEFRO-NL)
Would you like to know more about our foundation, or would you like to use our services? Please reach out to Antina at info@nefro-nl.nl and we will answer you as soon as possible.
Antina de Boer, project manager