Clinical Trial Services

Clinical Trial Services

Services that we can provide include:

  • Design and custom compounding or manufacturing of active and placebo drug dosage forms
  • Assemble clinical trial patient kits and documentation including
  • Drug preparation

Process validation:

  • Aseptic fill processes
  • Sterilization processes
  • Filtration processes
  • Depyrogenation processes
  • Batch compounding processes

Patient tracking:

  • Blinding or open labeling of study drug
  • Randomization of enrolled subject

Clinical site order placement and tracking:

  • Customer website for order placement, patient tracking, randomization
  • Multiple website log ins for each clinical site and varied user roles
  • Secure High-grade Encryption (RC4 128bit) Secure sockets layer (SSL)
  • Customized reports and online monitoring of websites
  • Activity logs (Audit logs) precisely track all sensitive activities and continuously record to SQL server database
  • Part 11 compliance

Investigational New Drug Application support documentation and consultation:

  • Chemistry Control and Manufacturing services support
  • Institutional Review Board support