McGuff Clinical Trial Services

Research is to see what everybody else has seen, and to think what nobody else has thought. Pharmaceutical Manufacturing

– Albert Szent-Gyorgyi

Clinical Trials - Services We Provide

Services that we can provide include, but are not limited to:

Sponsor

  • Chemistry Manufacturing and Control (CMC section) services
  • Investigational New Drug Application support documentation and consultation:
    • Institutional Review Board support
    • Regulatory affairs
    • Quality Assurance
  • Double blind study support

Product

  • Design and custom compounding or manufacturing of active and placebo drug dosage forms
  • Over encapsulation
  • Aseptic fill processes
  • Sterilization processes
  • Filtration processes
  • Depyrogenation processes
  • Batch compounding processes
  • Drug / Device combinations
    • Aseptic drug transfer to device
    • Aseptic drug transfer from device to container
    • Drug transfer from device to packaging
    • Drug transfer from packaging to device
  • Blind or open labeling of study drug
  • Clinical product development through commercial manufacturing
  • Product types:
    • Injectable
      • Intravenous
      • Intramuscular
      • Subcutaneous
    • Oral
      • Capsules
      • Suspensions
    • Solutions
    • Sublingual
      • Drops
      • Troches, which are a small tablet or lozenge
    • Topical
      • Creams
      • Lotions
      • Gels
      • PLO gels
      • Ointments
      • Solutions
      • Inhalations
      • Nasal Solutions
    • Suppositories
      • Rectal
      • Vaginal
      • Rectal enemas
      • Vaginal creams

Clinical Site and Patient

  • Patient tracking:
    • Randomization of enrolled subject
  • Clinical site order placement and tracking
  • Assemble clinical trial patient kits and documentation including
    • Drug preparation
    • Process validation

Part 11 Compliant Website

  • Customized website for patient enrollment, order placement, patient tracking, randomization and order review for compliance
  • Multiple website logins 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 with
  • Activity logs (Audit logs) precisely track all sensitive activities and continuously record to SQL server database
  • Electronic Data Interchange

Assistance to Investigators

We are committed to the success of your clinical trial even before we sign an agreement.

We understand what is at stake for your organization and how dependent you are on your contracted vendors to perform. We also recognize your time is valuable.

We promise to provide truthful answers to all your questions. We promise to be honest in our evaluation of ourselves and our ability to successfully meet your requirements. If we believe we are unable to provide you with outstanding service you deserve, we will say so up front.

After initial discussions, it is our desire that you come to our facilities for further discussions and audit. We want our clinical trial investigators and sponsors to understand our level of commitment first hand. We also want you to be absolutely sure of our people, their expertise and ability to help.

No questions should remain unanswered. Your confidence in us must be based on an understanding of who we are and how we operate.

We are here to help. Let us show you how.

Clinical Trials Request