Study Start-Up
Site identification and feasibility, contract negotiations, and regulatory and ethics committee submissions across Sweden, Norway and Denmark.
Overview
Study start-up covers everything required to activate clinical trial sites. From identifying suitable clinics and confirming their eligibility, through contract negotiations between sponsors, CROs and sites, to regulatory and ethics committee submissions throughout the clinical trial lifecycle.
Nordic Trial Partners handles study start-up across all three Scandinavian countries from a single point of contact, removing the need for separate national subcontractors.
What this covers
Site identification and feasibility assessments
Contract negotiations between sponsors, CROs and clinical sites
Ethics committee submissions and correspondence
Competent authority applications
Regulatory submissions throughout the trial lifecycle
Site activation and readiness confirmation
Track record
60+ ethics committee submissions, 40+ competent authority applications, and 60+ contract negotiations completed across Sweden, Norway and Denmark. Both pharmaceutical and medical device studies.
Who this is for
International CROs looking for a single local partner to handle site activation across Scandinavia. Biotech and pharmaceutical sponsors planning Nordic trial sites. Medical device companies needing regulatory submissions for pre- or post-market studies in the region.
Coverage
Sweden, Norway and Denmark. Local presence across all three Scandinavian countries.
Sectors
Pharmaceuticals (Phase I-IV) and medical devices (pre- and post-market).
Get in touch
Discuss how Nordic Trial Partners can support your project.
— CASE EXAMPLE
Study Start-Up in Practice
ANONYMISED CASE STUDY
One partner across Sweden, Norway and Denmark
The challenge:
An American rare disease biotech ran two late-phase paediatric programmes through a top-10 CRO: six studies across up to ten countries. Sweden, Norway and Denmark were chosen for their recruitment potential and key opinion leaders. From the first study, start-up slipped in most countries, and the Nordics were the worst affected. The CRO covered the three countries with six different people, separate study start-up managers and monitors in each, working across three regulatory environments with different site contracting and monitoring practices. The region became a costly, friction-heavy part of the programme.
What we did:
For the second study, a Phase III trial run under the EU Clinical Trials Regulation and submitted through CTIS, the CRO subcontracted David, through Nordic Trial Partners, to run study start-up across all three Nordic countries: site contracting, local regulatory guidance and CTIS submissions, handled by one partner.
The outcome:
Sweden, Norway and Denmark were the first three countries in Europe to activate sites and recruit participants, third, first and second respectively. The sponsor congratulated the investigators on their performance. David ran study start-up for the next three studies with the same result each time. For the sixth study the CRO used a different supplier, and none of the Nordic countries activated or recruited early.
— RELATED SERVICES
Other Services
Clinical Operations
Strategic and operational oversight of clinical programmes. Cross-functional team leadership, budget and timeline management.
Site Monitoring
On-site and remote monitoring to protect participant rights, ensure data integrity and verify protocol compliance.
Need Clinical Research Support?
Get in touch to discuss your project. Typically responds within 24 hours.