CLINCIAL RESEARCH

Clinical research covers a broad area with a number of specialized tasks.

Bruce Consulting offers to solve tasks within these areas.

On this page you wil find more information about which types of task we offer to assist with.

The list is not comprehensive, so do not hesitate to contact us, if you want further information.

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Application to authorities:

Submission to Danish as well as international authorities.

Do you need to submit a study or an amendment to the Ethics Committee and/or Health Authorities? We can also assist you on this. Bruce Consulting can handle either the complete submission or parts of it – this is entirely up to you.

We also offer to handle the contact with the national coordinating investigator in relation to submissions.

Development of clinical study documents

  • Synopsis & study protocols
    • Development of clinical study protocols and synopsis in phase I-IV. We can assist in writing part of the synopsis and study protocol, and also handle the coordination and management of the team developing and writing the synopsis and protocol
  • Participant Information
  • Power of attorney
  • Layman protocols
  • Monitoring plans
  • Monitoring strategies
  • Recruitment materials
  • Source data sheets
  • Compliance sheets
  • Diaries to study participants.

Feasibilities including assessment and qualification of sites

Initiation meetings including training of clinical study personnel

Monitoring:

  • Initiation
  • On-site monitoring
  • Remote monitoring
  • Co-monitoring
  • Closure of sites

Quality assessment site visits

Project management:

  • Management and training of study teams
  • Planning, negotiation and overview of study budgets
  • Recruitment
  • Compliance with timelines
  • Review of monitoring reports
  • Quality assessment and assurance of monitors

Vendor management including quality assessment of vendors

Follow-up and control of CRO performance and results