Clinical Operations
Strategic and operational oversight of clinical programmes. Leading cross-functional teams in planning and delivery of studies to scope, quality, budget and timelines.
Overview
Nordic Trial Partners provides clinical operations services at both strategic and operational levels. This includes leading cross-functional teams of specialists in the planning and delivery of clinical programmes and trials, managing scope, quality, budget, timelines, resources and risk.
Clinical operations oversight extends to regulatory market authorisation submissions and lifecycle management, ensuring programmes remain compliant and on track from first-in-human through to post-approval commitments.
What this covers
Clinical programme planning and oversight across multiple studies
Study management
Cross-functional team leadership and vendor management
Budget, timeline and resource management
Risk identification and mitigation planning
Leading teams for Regulatory market authorisation submissions
Leading teams through lifecycle management and post-approval commitments
SOP development and quality system improvement
GCP advisory services
Authoring services
Who this is for
International CROs needing senior operational oversight for trials. Pharmaceutical and biotech sponsors running clinical programmes in need of senior strategic or operational support. Medical device manufacturers requiring experienced clinical project management for pre- and post-market studies.
How it works
Our senior expert works as an embedded extension of the client team, taking direct ownership of deliverables rather than providing advisory support from a distance. Engagements are typically 0.5-1.0 FTE over periods of months to years, with the flexibility to scale as programme demands change.
Global coverage, remotely. Local presence across all three Scandinavian countries.
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
Clinical Operations in Practice
ANONYMISED CASE STUDY
A programme-critical Phase III application brought into line with new EU rules
The challenge:
When the EU Clinical Trials Regulation (536/2014) took effect, a large pharmaceutical company found that a programme-critical Phase III Clinical Trial Application carried immediate regulatory risk under the new transparency rules. Programme timelines and budget were exposed.
What we did:
Our senior consultant was appointed project manager to bring the application into compliance with the transparency rules, the redaction of commercially confidential information and personal data. He worked across Regulatory Affairs, Clinical, Biometrics, Medical Writing, Pharmacovigilance and Data Management, drawing directly on the relevant EMA regulations and guidance, to make the dossier compliant.
The outcome:
The application was submitted compliant and the trial was approved. David was then made the clinical operations subject matter expert on the company's clinical trial transparency group, shaping SOPs, internal guidance and work instructions, training clinical operations teams across the company, and guiding a project team through transparency requirements during the acquisition of a new molecular entity.
ANONYMISED CASE STUDY
Closing EU MDR clinical evidence gaps before certification
The challenge:
A global mid-sized medical device manufacturer faced the EU Medical Device Regulation (MDR, 2017/745), which demands stronger clinical evidence, post-market surveillance and life-cycle traceability. The company relied on a long-established Class Is sterile product family and was preparing to launch a more complex Class II device. A cross-functional gap analysis found major gaps in its SOPs, from early development through to clinical evidence generation and life-cycle management. With the Notified Body scheduled to certify both products under the MDR, both were at immediate risk.
What we did:
With limited internal resources, our senior consultant was brought in for his ISO 14155:2020 gap-analysis experience to lead the revision of the affected SOPs hands-on: interpreting the regulation and guidance, coordinating across functions, and authoring procedures. He drafted new SOPs and work instructions for Clinical Evaluations, Post-Market Surveillance and Post-Market Clinical Follow-Up, and trained internal teams. Applying the new tools, the clinical evaluators identified the remaining evidence gaps.
The outcome:
Ahead of the Notified Body's technical documentation review, he designed the pre-market and post-market (PMCF) clinical investigation plans to close those gaps. The clinical team executed the investigations successfully, and both products achieved CE marking under the MDR.
— RELATED SERVICES
Other Services
Study Start-Up
Site identification, feasibility, contract negotiations and regulatory submissions across Sweden, Norway and Denmark.
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.