Marketing Authorization Check

Ensure your study has the best chance for success from the start to finish with our free marketing authorization check.

Make sure you are successful with your study and gain marketing approval for research drug/device. Avoid any unexpected surprises when you submit your trial for approval by speaking with our consultants who will give your study a free marketing approval check to ensure you have the best possible chance of success. As Biostatistics and Data Experts we bring our collective experience to reduce your risk of a failed submission.

How does it work?

Our consultants will examine your protocol and proposed study plan and then ask a series of questions about your study so we can advise on the best possible steps. Our Marketing Authorization Check is ideal for:

Individual Studies
Integrated Summaries
On-going Studies/Mid-Study rescues

3 Steps to receiving your Free Marketing Authorization Check

Step 1

  • Complete the form below and let us know the areas and aspects of consultation you would like to receive for your trial
  • A member of our team will be in touch to schedule the call with our consultants

Step 2

  • Sign a CDA so we can get into the detail of your trial
  • Provide details of whether the enquiry is for an individual study or an ISS/ISE
  • Provide any study documentation to help us deliver the required consultation

Step 3

  • If, for an individual study, our trial experts will review your protocol, examine your current planned trial methodology and be prepared to discuss strategy
  • For integrated summaries we will examine your submission proposal and advise accordingly
  • Attend your Marketing Authorization Check meeting to receive your free advice as we help your study become fit for submission

Questions you can expect to hear

  • What are the regulatory documents that you want us to write?
  • Which regulatory agencies do you want to submit the documents to?
  • Do you need support with the submission of the the common technical document?
  • What regulatory body do you require approval from?
  • Are your datasets submission ready?
  • Are you following the latest CDISC guidelines?
  • What automations and macros are in place when generating TFLs?
  • SDTM & ADaMs?

If your planning or conducting a single study:

  • Do you have a statistician to sign-off your protocol?
  • Do you want to know what the implications are for trial success of changing power from 90% to 80%
  • How do I blind a study and create a randomization list?
  • Is this study part of a portfolio due for submission? Consistency is key.

 

If your planning or conducting a submission compiling multiple studies with an ISS/ISE:

  • How many studies are being combined? 
  • What phase/indication?
  • Is gap analysis required?
  • How to decide on the best suitable EDC solution for a complex long term oncology study? 
  • How do you ensure outstanding issues are appropriately evaluated and documented at the DBL?
  • How are you handling your external data (lab, IVRS, ECG, PRO etc.)?
  • How can protocol deviation process be defined in a DMP?
  • When would you need your AE/CM terms re-coded to the latest dictionary?
  • Are you able to plan data capture for your study in line with your protocol?
  • Are you having troubles implementing CDASH standards and SDTM?

Receive your free Marketing Authorization Check