SCIAN: Oncology EDC Clinical Trials - SaaS Delivered - proof of concept phase iii edc databases

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

SCIAN: Oncology EDC Clinical Trials - SaaS Delivered

Proof of Concept - Phase I/II EDC Databases

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 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 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

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

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Autoimmune, inflammatory; Cardiovascular; CNS, Neurology, Pain; Dermatology; Diabetes, metabolic; Gastroenterology; Infectious diseases; and Respiratory diseases. These database libraries have been developped on indication-specific clinical standards, such as NCI's Common Data Elements and CDISC's CDASH specifications. Hosting of configured study and safety databases - backup on specific data management tasks by SciAn.