What We Provide

We deliver bespoke solutions to meet the needs of our clients. We can provide ad hoc support for an urgent project, monitoring one of your sites or full-scale project management from the beginning to end of the study. We will meet you to understand your needs and will work together to design our services around your unique requirements. We have extensive experience managing and monitoring clinical trials in the UK and Europe, and are certain that we will able to make your project a successful one.

 


 

Project Management

  • Study Design and Planning
  • Protocol, CRF and PIS/ICF Development
  • Budget Development and Negotiation
  • Investigator Meetings and Site Staff Training
  • Patient Recruitment and Retention Strategy
  • Set-Up and Maintenance of Trial Master File
  • Develop Monitoring and Management Forms and Tools
  • Vendor Management

Clinical Trials Support Company in UK  and Europe
 

Clinical Monitoring and Site Management

  • All Types of Monitoring Visits
  • Quality Control Visits
  • Site Preparation for Audits and Inspections
  • Investigational Site Selection and Feasibility
  • Investigational Site Set-Up
  • Clinical Trial Agreement Negotiation
  • Investigational Site File Creation and Review

 

Regulatory Affairs

  • Central Ethics Committee Submissions
  • Regulatory Authority Submissions
  • HRA and R&D Submissions
  • Amendment Submissions
  • Safety Reporting
  • Submissions of Progress Reports and Final Reports
  • Attend Ethics Committee Meetings
  • Regulatory Consultancy
  • Acting as the Point of Contact for Regulatory Authorities and Ethics Committees

 

 

 

 

 

In every clinical trial we manage and monitor, whether it be in the UK or Europe, we aim to run it as smooth as possible. We always build great relationships with site staff and follow up on outstanding actions in a timely manner. We have the ability to proactively identify challenges and risks, and their origins, to propose solutions to problems and to escalate when deemed necessary.  We have developed the analytical skills to make decisions independently, and as part of a group, taking into consideration timeframes, available resources and team dynamics.

 


 

 

 

 

 

Why Choose Us

  • We are agile. We operate 24/7. We are flexible and offer easy access. We respond to emails during evenings to facilitate different time-zones. Also, if needed, we conduct monitoring visits during weekends to catch protocol’s timetable and confirm eligibility prior to early Monday morning dose in phase 1 studies.
  • We are reliable. You will always have one point of contact throughout the study as our team is stable and dedicated to your project. We do not face high-turnover issues.
  • We offer solutions when budget is limited; we can offer tailored solutions to your financial resources.