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Scientific affairs focus of competences in clinical studies. We outsource specialists and offer ad-hoc support to our clients. We will help you to get new drugs, 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. Our outsourcing solutions may be long term or short term, full time or part time, single or multiple consultant approach, senior or junior competence. We can offer solutions that cover one or all Nordic countries. We prefer to create long term value and work in partnership, but we also take on smaller projects, solve peak capacity challanges and help you with limited projects.

We are not just a provider, we will be your partner!


We can support you with:

  • 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


We can support you with:

  • Clinical Data Manager/Senior Data Manager

  • Principal Clinical Data Manager

  • Biostatistician/Senior Biostatistician

  • Principal Biostatistician

  • Writing of Statistical Analysis Plan and Data Management Plan


We can support you with:

  • 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

Investigator initiated trials

  • IIT oversight

  • Quality control

  • Site quality review/audit


We can support you with:

  • 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


Diagnostics and the Laboratory sector is a very vibrant sector at present with a large demand for new talent, we will be able to help you with this demand.


We can support you with:

Outsourcing of specialists:

  • Medical writer

  • Medical Advisor Services

  • Medical Monitoring

Ad-hoc support:

  • Clinical Study Protocol (CSP) or Clinical Investigation Plan (CIP

  • Investigator’s Brochure (IB)

  • Patient Information and Informed Consent Form (ICF)

  • Clinical Evaluation

  • Clinical Study Report (CSR) or Clinical Investigation Report (CIR)

  • Clinical Overview and Summary

  • Literature search

  • Non-interventional Study Protocol

  • Protocol for Post-marketing Safety and/or Efficacy Study

  • Post-marketing Clinical Follow-up (PMCF) Plan

  • Update of your Clinical Evaluation

  • Posters and Scientific Article

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