Clinical Development Services

Integrated clinical development capabilities supporting research, data science, regulatory strategy, and global trials.

Clinical Development

End-to-end clinical development expertise from protocol design to regulatory submission.

Clinical Research & Operations

  • Protocol design
  • Site feasibility & startup
  • SIV / IMV / Close-out visits
  • Patient recruitment & retention
  • Hybrid & decentralized trials
  • Medical monitoring
  • TMF / CTMS oversight

Data Management

  • EDC build & validation
  • ePRO / eCOA integration
  • Edit checks
  • Data cleaning
  • SAE reconciliation
  • SDTM mapping
  • Database lock (DBL)

Biometrics

  • Statistical Analysis Plan (SAP)
  • Randomization
  • Sample size estimation
  • Interim analyses
  • IDMC / DSMB support
  • TLFs generation
  • SDTM / ADaM datasets

HEOR / RWE

  • Value dossiers
  • BIM / CEA models
  • Registry builds
  • Claims & EMR analytics
  • Payer evidence strategy
  • Pricing & reimbursement planning

Drug Safety & Pharmacovigilance

  • Case intake & triage
  • MedDRA coding
  • Safety narratives
  • Signal detection
  • RMP / REMS
  • PSUR / DSUR reporting

Regulatory Affairs

  • IND / IDE strategy
  • NDA / BLA / ANDA
  • 510(k) / PMA / De Novo
  • eCTD publishing
  • Health authority meetings

Biomarkers & Translational Science

  • Biomarker strategy
  • Assay development
  • Assay validation (GCLP)
  • Companion diagnostics
  • Biobanking logistics

Clinical Pharmacology / PK-PD

  • Population PK
  • Exposure-response modeling
  • NCA & compartmental analysis
  • Drug interaction studies
  • Dose optimization

Medical Affairs

  • Scientific communications
  • MSL toolkits
  • Congress support
  • Publications planning
  • KOL engagement
  • Evidence synthesis