Our services light the way through the complexities of clinical development.

Allucent’s regulatory, product development, and clinical research solutions are purpose-built for the needs of small and mid-sized biotechs.

The drug development lifecycle

Targeted for small and mid-sized biotech companies in areas that are import to your business cycle, we have the capabilities of a larger CRO but customized to meet your unique needs.

Nonclinical

  • Development Planning and Gap
  • Sample size and power calculations
  • Health authority meetings
  • Regulatory filings IND/IMPD/CTA

Phase 1

  • Clinical pharmacology plan
  • Study protocol
  • First in human proof of principal

Phase 2

  • Rare disease designation
  • Study initiated
  • Interim analysis
  • In-house database lock
  • Results

Phase 3

  • Study initiated
  • In-house database lock
  • Regulatory filings BLA/NDA/MAA

Approval & Product Launch

  • Post-submission rapid response
  • Inspection readiness
  • Advisory meetings
  • Brief packet preparation

Expertise that solves your complex challenges