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
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
- Head & Neck Cancer
- Non-Small Cell Lung Cancer
- Pancreatic Cancer
- Prostate Cancer.
Databases by clinical phase and study
Phase I/II Safety / MTD
- 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
- 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
- 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.