SUBMIT RFI

Thinking of outsourcing some clinical trial work?

Here are some tips to help ease the process of requesting bids and proposals:

• Include a table of what you would like PHASTAR to do, and what your company will retain responsibility for
  
  
• If you are outsourcing a clinical trial analysis, we will need estimates of how many tables, figures and listings will be required. We can estimate this but it may be more accurate if you can provide an estimate. Ideally, split estimates of the numbers into unique and duplicate outputs for a more precise quote
  
  
• If you are going to submit a clinical trial analysis to a regulatory body, either now or in the future, then we would advise that CDISC standards are followed. However, this requires additional resources and cost. Please consider whether this is necessary for your study
  
  
• Does your study have any complexities that we should know about? Please let us know this in advance. Similarly, if your study is straightforward, please let us know this as well
  
  
• Will you require a programmatic review of protocol deviations?
  
  
• How many times will you want to run a set of outputs? Are there outputs required for an interim analysis or a regular safety review?
  
  
• Do you require an analysis plan to be written? Will the analysis plan contain template or mock outputs?
  
  
• We would recommend the creation of dataset specifications to be created for all studies. If these are not required for your study, are they available from another source (e.g. internal company standards)?
  
  
• For CDISC studies, normally a "CRT package" is required that contains datasets and documentation that can be sent directly to regulatory bodies in a standardised form. This comprises submission-ready datasets and a set of documentation e.g. define.xml with reviewers' guide
  
  
• What form of validation documentation will you require to be returned at the end of the study?
  
  
• How good is the quality of your data? If electronic data entry is used at clinical sites, is there a data management team monitoring and checking the data? Are we required to carry out any data checks?
  
  
• Is a statistical report required? This can either document statistical assumptions, or provide an objective report of the results of your trial
  
  
• What statistical input will be required to create your clinical study report?
  
  
• Are patient narratives required? Are these to be programmed, or manually created?
  
  
• Do you need support to submit the trial results to registries such as clintrials.gov?
  
  
• Will you want statistical and programming support after the final delivery of results to carry out exploratory analyses?
  
  
• Will you require statistical support for the interpretation of the results?
  
  
• Will a slideset of the results be required?
  
  
• Do you require PHASTAR to create a clinical study report, with all appendices for the study?
  
  
• Are there any circumstances when you may wish to create a summary report?