Data Preparation for Marketing Applications

Collecting, Standardizing and Analyzing Your Clinical Trial Data is Critical No Matter What Phase of Clinical Development You are In

We understand that nothing is more important than efficiently collecting and standardizing your clinical trial data - especially if you plan to use that data for your marketing application(s). As you start preparing for your NDA/BLA or MAA, a significant consideration in planning your timeline will depend on how SDTM compliant your clinical data currently is.  

The sooner you know, the quicker you can start converting your data into submission-ready format to avoid medical writing or publishing delays as you get closer to your submission date.  

Make The Right Decisions For Your Data at the Right Time

Are you Planning or Conducting Trials?

Our teams can help you successfully plan and execute your trials and programs with your short- and long-term goals in mind.   

Ask yourself the following questions: 

  • Should I consider an Adaptive Design?  What should I know before planning?   Read Blog
  •  How SDTM compliant should my clinical trial database be?  There are multiple database design considerations -  View Infographic
  • Will I gain efficiencies by having the same team design my clinical trial database for my Phase II and Phase III trials?   Read Case Study
  • Do I really need an external biostats and programming partner?     Read Story
  • How to I get my data ready for Data Review Committees:   Learn More.

Are you Planning Your Marketing Application?

Due to our unrivaled marketing application preparation experience, our teams are adept at overcoming data analysis challenges.  

Learn from our examples: 

  • Successful Preparation Strategies for NDA/MAA Marketing Applications - Read White Paper
  • Achieving an aggressive NDA timeline, despite a 2 month database lock delay for the pivotal trial - Read Story
  • Preparing a data analysis strategy to include in an NDA, for a purchased compound with multiple ongoing studies - Read Case Study
  • Tips for overcoming data analysis difficulties during NDA/MAA submissions  Read Blog

Is COVID-19 Impacting Your Programs?

Resources for Clinical Trial Conduct During COVID-19 

Whether you have ongoing programs for COVID-19 vaccines or treatments or are just trying to minimize the risk for current or planned clinical trials during this pandemic, our teams can help.   Visit our COVID-19 Resource Center to learn more.

COVID-19 Resources

 

Clinical data conversion into submission-ready formatMeet Veristat

We understand that for novel drug development,  once all the easy challenges are conquered, you need to overcome process and scientific unknowns. To give you an advantage, Veristat has assembled a team of scientific-minded experts adept at strategy and execution.

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