Product Development
Services /
Product Development

Phase I-IIa

TRI realizes the importance of conducting an efficient Phase I clinical trial. TRI’s Early Phase experts work side-by-side with our clients to achieve this goal. Our services include:

  • First-In-Human Studies
  • Dose Escalation
  • Bioavailability / Bioequivalence
  • Pharmacokinetic / Pharmacodynamic (PK/PD)
  • Drug-Drug Interaction
  • Food Effect Studies
  • Biomarker development and analysis
  • Novel Delivery Systems
  • Challenge Studies
  • Proof of Concept

Phase II/III

TRI specializes in the planning and execution of phase II/III trials in infectious diseases, cancer, women’s health, and addiction medicine. We support single studies and, more often, entire research programs. Our services are deployed individually (functional service provider model) or as an integrated solution.

  • First-In-Human Studies
  • Dose Escalation
  • Bioavailability / Bioequivalence
  • Pharmacokinetic / Pharmacodynamic (PK/PD)
  • Drug-Drug Interaction
  • Food Effect Studies
  • Biomarker development and analysis
  • Novel Delivery Systems
  • Challenge Studies
  • Proof of Concept

Phase IV

After the success of the clinical trials and FDA approval TRI’s team communications specialists, medical, and regulatory affairs experts ensure the commercial viability of the new product.

The therapeutic will continue to be tested in sponsor-approved studies to further demonstrate effectiveness and safety. TRI has a foothold in the global healthcare community to produce the large trial populations needed to validate clinical trial test results. Some of our services include:

  • Development of journal articles, reports, abstracts and other materials to create a narrative and differentiate a therapeutic from competitors on the market
  • Development of up-to-code dossiers for foreign registration
  • Post marketing Pharmacovigilance support
  • Observational studies and registries
  • Development, implementation, and auditing of manufacturing and distribution quality systems

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