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