Study Managment
TrialAssist can provide help in all aspects of study management including,
DESIGN
• Protocol design,
• Compilation of the patient information sheet (PIS) and consent forms
• CRF design which should ideally be coordinated with data-handling and statistical services
• TrialAssist has access to CRF printing resources if required.
REGULATORY
TrialAssist has a wide experience of liaising with
• regulatory agencies
• ethical committees both in the UK and in Europe.
TRIAL MANAGEMENT AND SITE SET-UP
Careful and consistent organisation of the documentation associated with a clinical study is important if the study is to be brought to a successful conclusion.
TrialAssist can help with
• setting up and maintaining the Trial Master File and/or Study Site File
• delegation and responsibility lists
• archiving arrangements in line with current data protection legislation.
PATIENT SAFETY
TrialAssist can help with
• pharmacovigilance requirements
• safety reporting.
• Trial insurance
TRAINING
TrialAssist can help ensure that the Investigator and site staff are well trained in
both ICH/GCP and specific study procedures.
DRUG AVAILABILITY, STORAGE AND ACCOUNTABILITY
TrialAssist can
• Advise the investigator about appropriate storage and accountability systems.
• Set up an economical IVRS randomization system.
ANALYSIS AND REPORTING
TrialAssist can help, in association with the Robertson Centre for Biostatistics at Glasgow
University, with
• data handling
• statistical services
• statistical and final reports.
TrialAssist can help with publication and presentation materials.
PROGRESS REPORTING
From a company perspective it is often difficult to assess the progress of an IST.
TrialAssist can provide regular reports to the funding company on the progress of
studies, allowing milestone payments and forward planning of dissemination of study
results where appropriate.
Please contact TrialAssist for help with all of your Investigator Sponsored Trials.