Solutions for Proof-of-Concept Phase I/II Trials
Fully configured EDC study databases developed on SCiAN's
EDCPRO platform are available for IND stage
phase I/II clinical studies on a monthly subscription
basis.
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 Indication / Therapeutic Area
- Autoimmune - Inflammatory
- Cardiovascular
- CNS - Neurology - Pain
- Dermatology
- Diabetes - Metabolic
- Gastroenterology
- Infectious diseases
- Respiratory.
Databases by Study
Design1
- Dose-escalation: open-label, single-arm
- Dose-escalation: randomized, placebo-controlled (blinded)
design
- Parallel group randomized (blinded) dose ranging
w/out placebo group
- Dose-escalation CRM design - original
- 2-stage / multi-stage designs
- Open label and other parallel group designs
- Adaptive designs.
1) PK, PD and biomarker sub-studies supported