Generics Industry

Want to be the First to File?

Experts in Generic and Innovator Drug Development:

We understand that first to file and capital efficient clinical trials are key to a successful generics company.

Be The First to File: Integrium produces rapid results. In as little as 90 days, Integrium can take you through Pk Trials and have you ready for an Enpoint Trial.

  • IND Creation
  • Protocol Development
  • IRB Submission
  • Patient Recruitment/Enrollment
  • Study Conduct
  • Topline Results

Who We Serve

  • Generics companies
  • Early stage companies entering Phase I or Phase IIA clinical trials
  • VC and PE investors
  • Pharma spinoff companies
  • University incubators and pre-spinoff opportunities

Integration by Integrium

Phase I/PK studies:

  • Pharmacokinetics / Pharmacodynamics
  • Single /Multiple Ascending Dose
  • Dose Ranging
  • Maximum Tolerated Dose
  • Bioavailability / Bioequivalence
  • Indication-Specific
  • Proof of Concept
  • Special Populations
  • Through QT/QTc
  • Food Effect
  • Drug-Drug Interaction
  • Abuse-Liability

What We Offer

  • Expert Study Design and Protocol Writing
  • Rapid Enrollment
  • Fully-Equipped 52-Bed Clinical Research Unit with:
    • Extensive Subject Database
    • ECG, ABPM, Holter Monitoring
    • Thorough QT/QTc, Telemetry
    • PK/PD
  • Medical Monitoring
  • Data Management and Biostatistics
  • Clinical Study Reports