We can assist with:

• turning a proposal for funding into a full protocol
• development of data capture forms and systems
• programming/set up of trial databases
• acquisition of questionnaires
• development of trial-specific manuals of procedures and standard operating procedures
• application for NIHR portfolio adoption
• application to MHRA
  • registering study with EUDRACT
  • preparation & submission of CTA application
• application for ethical favourable opinion
  • preparation of Patient Information Sheet and Consent Forms
  • completion and submission of REC form
• application for Trust R&D approval, via CSP
  • preparation of ‘global’ R&D form
  • guidance on completion of Sites Specific Information Forms where appropriate 
• advice on obtaining honorary NHS contracts / research passports as required
• registration of the trial on a publicly accessible database/register
• applications for other permissions and approvals as required
• set-up of Trial Master File
• liaison with trial sites
• investigator meetings and site initiation visits