Support we provide

We can support the researcher at the trial set-up phase by:

• Assisting with the Grant application - whether outline or full applications
• Identifying an appropriate funding stream

We offer statistical support, for example:

• Sample size calculations
• Methodology advice
• Advice on appropriate outcome measures
• Generation of randomisation sequence

We can also support the researcher by:

• Setting the budget and timeline
• Feasibility and site selection activity
• Protocol preparation
• Patient information and consent form writing
• Designing data capture forms and guidelines
• MACRO database design
• Writing study specific procedures/SOPs
• Preparing the study handbook for site staff
• Ethics and regulatory submissions
• Obtaining NIHR portfolio adoption
• Obtaining R&D permissions from each site
• Data Monitoring Committee and Trial Steering Committee set-up
• Organising Investigator Meetings
• Conducting site initiation visits
• IMP management
• Setting up trial master file
• Registration of trial on a publicly accessible website
• Setting up a trial website
• Setting up a randomisation service

We can support the researcher at the recruitment phase with the following

• Site oversight, motivation and monitoring (on site and remote)
• Site support, including recruitment strategies
• Preparation and dissemination of newsletters
• Maintenance of trial website
• Adverse event management
• Data Management
  • Data entry
  • Generation of data queries
  • Screening log management
• Statistical services
  • Interim analyses as required
• Provision of unblinded data for Data Monitoring Committee (DMC) reports
  • Input into other reports as required
• Assist with preparation and submission of interim reports to:
  • Sponsor
  • R&D departments
  • Ethics committee
  • Regulatory authorities
• Organisation of Trial Steering Committee (TSC) and DMC meetings

Once recruitment is complete, we can support the investigator with the following activities:

• Prompt resolution of outstanding data queries
• Data cleaning
• Database Quality Assurance activities
• Statistical analysis and interpretation of results
• Report writing for funders, sponsors, ethics committee and regulatory authorities
• Close down of sites
• Archiving of trial documentation

At this stage, we can assist with:

• Contributing to manuscripts for publication
• Dissemination of results to trial participants and other interested parties