Oncology Clinical Trials

SCiAN's 28 years of experience in oncology trials as a leading North-American CRO covering all data functions, including trial design, EDC, data management, pharmacovigilance, DSMBs/DMCs, biometrics and reporting:  

  • Acute Myeloid Leukemia (AML)
  • Chronic Lymphocytic Leukemia (CLL)
  • Chronic Myeloid Leukemia (CML)
  • Non-Hodgkin Lymphomas (NHLs)
  • Basal Cell Carcinoma
  • Breast Cancer
  • Colorectal Cancer
  • Gliomas
  • Head & Neck Cancer
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
  • Prostate Cancer.

Clinical phase and study design

 Phase I/II  Safety / MTD studies1,2

  • Dose-escalation 3+3 / 1-in-3 design
  • Variations of the 3+3 design
  • Dose-escalation CRM design - original
  • Dose-escalation mCRM design - published modification by SciAn3
  • Dose-escalation xCRM design - 3rd-party modified design
  • Open label and other parallel group designs.

1) Studies with single target vs. multiple tumor types; with/out long-term survival follow-up
2) PK and PD sub-studies supported
3) "Phase I dose escalation of gemcitabine and cisplatin for Advanced non-small cell lung cancer: usefulness of Mathematical modeling to determine maximum tolerable dose", FA Sheppard, R. Burkes, Y Cormier, M Crump, R Feld, T Strack and M Schulz, Journal of Clinical Oncology, Vol 14, 1656-1662.

Phase II Exploratory Efficacy Trials4

  • Open-label single arm/stage design (single dose level)
  • Open-label 2-stage design (single dose level)
  • Open-label / randomized 2-stage design - 2 parallel groups
  • Open-label multi-stage designs
  • Randomized, active/placebo controlled parallel design (with 1 or more dose levels)
  • Adaptive designs.

4) PK and PD and biomarker studies supported.

Phase IIb/III Confirmatory Efficacy Trials

  • Open-label designs
  • Randomized parallel-group designs
  • Sequential / multi-stage designs
  • Seamless phase II/III designs.