Clinical development
WE ARE NOT JUST A PROVIDER, WE WILL BE YOUR NORDIC PARTNER!
We outsource specialists and offer ad-hoc support to our clients. We will help you to get new pharmaceuticals, products, methods, and devices to the market faster.
We develop your organization with our highly competent consultants. Our experts add more than just skills and competence, they add experience and know-how from the industry and many different companies. We work across all Nordic countries.
Our main goal is to work closely together with you and solve your challenges in a flexible manner.
We offer you flexible solutions and take on both smaller projects involving only one expert and a few hours as well as bigger projects involving several competencies. We solve peak capacity challenges and help you with limited projects.
Click on one of the below services to find out what we can support you with:
Clinical Operations
Outsourcing of specialists:
- Clinical Research Assistant, CTA
- Clinical Research Associate, CRA
- Clinical Research Manager/Lead-CRA
- Clinical Project Manager
- Project Director
- Clinical Operations Director
Ad-hoc support
- Pre-study planning
- Feasibility and site selection support
- Support in study protocol development
- Submission to authorities and ethics committees.
- Informed consent writing and adaptation
- Monitoring
- Review of monitoring reports
- Co-monitoring
Biometrics
Outsourcing of specialists
- Clinical Data Manager/Senior Data Manager
- Principal Clinical Data Manager
- Biostatistician/Senior Biostatistician
- Principal Biostatistician
Ad hoc service:
- Study design
- Protocol input including advice on trial design, sample size calculation etc.
- Randomization
- Statistical analysis plan
- Data Management Plan
- Programming and data analysis
- Statistical consulting
- CRF review
- eCRF set-up
Full-service project
We can offer you a full-service solution with a team of experts in regulatory, medical writing, medical advisor, statistician, data manager and clinical project manager during your set-up and planning of your study, i.e protocol writing, calculating sample size, writing essential documents, SOP’s and application to authorities during the start of the project and with sponsor oversight throughout the complete study.