Clinical studies

Clinical development

WE ARE NOT JUST A PROVIDER, WE WILL BE YOUR NORDIC PARTNER!

SUPPORT THROUGHOUT THE WHOLE CLINICAL DEVELOPMENT

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
•   Clinical project management
•   Biometrics
•   Medical writing
•   Medical advise
•   RWE/Late phase studies
•   Investigator-initiated trials
•   Full-service projects

WE HELP YOU TO MOVE FROM THE PRE-CLINICAL TO THE CLINICAL PHASE

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

Clinical Project Management

Outsourcing Director
Sponsor Oversight
Liaison between sponsor, CRO, and vendors
Writing of Project Plans (e.g. Communication Plan, Project Management Plan, Quality Risk Management Plan, etc.)
Vendor Management
CRO Management

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

RWE/Late phase studies

Feasibilities

Set-up and planing
Submission to EC and site contracts

EDC system

Monitoring and project management of RWE studies
Remote monitoring
Quality control of register data
Site contact and motivational visits
Data entry

Onsite monitoring at clinical site

Investigator-initated studies

IIT oversight
Quality control
Site quality review/audit
Set-up and planing
Protocol writing
Study design
Set-up and planing
Onsite monitoring
Submission to EC and site contracts
Set-up of EDC system

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.