clinical research

​​call us
​
​
Write to us

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