SCIAN: Oncology EDC Clinical Trials - SaaS Delivered - oncology edc study databases

By: Scian  09-12-2011
Keywords: data management, Clinical Trials, Clinical Studies

SCIAN: Oncology EDC Clinical Trials - SaaS Delivered

Oncology EDC Study Databases

Fully configured oncology EDC study databases developed on SciAn's EDCPRO platform are available for IND stage (phases I - III) oncology clinical studies on a monthly subscription basis to enter, review, manage and report clinical study data.

EDCPRO is a powerful and effective Web-based clinical data management system that incorporates SciAn's 15 years of EDC knowledge and experience in managing oncology clinical trials.  Founded on our therapeutic area expertise, the intuitive user interface helps Study Coordinators and Monitors complete their data management tasks with ease, efficiency and minimum administrative overhead.

Sponsors can select a fully configured EDC study database from our extensive library based on patient population, the clinical phase and the design of the study: 

Databases by Patient Population

  • 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.

Databases by 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.

Phase IV Trials

  • Single / multi-center designs
  • Open-label parallel-group designs
  • Randomized parallel-group designs.

Keywords: Clinical Data, Clinical Data Management, Clinical Studies, Clinical Trials, Crm Design, data management, Data Management System, Intuitive user interface, Management Tasks, Study Coordinators, Study Design,

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