Clinical studies

Clinical studies

Women experts in pre-clinical studies

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

4 women in active consultancy meeting

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

Consultant explaining Sponsor oversight

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 expert consultants

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

Life Science consultancy wall

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

Computer PharmaRelations

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

Medical writing services for Life Science team

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

Women experts in pre-clinical studies
PharmaRelations office close 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.

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