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