Oncology Clinical Trials

Fully configured oncology EDC study databases developed on SCiAN's EDC^PRO 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.

EDC^PRO 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 studies^1,2

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.