Once the protocol is in place and the sites are ready to begin enrollment, your company needs a place to collect and manage all of the clinical research data that will be created during your study.  A simple homegrown database may be all you need or maybe you want electronic data capture (aka remote data entry) or a system designed for double-data entry from paper CRFs.  We have solutions for most of your data management situations.

Clinical Data Management:

For companies with no clinical data management system (CDMS):
  • We'll work with you to find the right vendor even if it's not one of our partners
  • We'll help you layout the database you need for your study
  • We'll design or oversee the design of your study database
  • We'll design, execute and document full verification and validation testing programs for your database
If you already have a CDMS:
  • We'll help you perform verification and validation testing
  • We'll oversee the data management for your study

Data Analysis/Biostatistics:

Biostatistic's support starts at the study design.  Our biostatisticians can provide you with guidance on sample size, randomization, study blinding and advanced statistical techniques like adaptive design and the enhancement design.  We can provide guidance or we can write the entire statistical analysis plan.

Once the data is in the database, it needs to be extracted and analyzed.  We'll help you pull the data out, complete analyses and prepare all of your study reports.  We'll even act as your biostatistical representative to the FDA.