Clinical Data Management
Experienced Team to support your clinical trials
As a North American science-technology based contract research
organization, clinical data management, SAE management,
biostatistics, and CSR writing have been the cornerstones of
SCiAN's business since 1986. Studies completed by SCiAN ranged
from small and complex phase II oncology trials to large-scale
global II/III trials managed in collaboration with the
Sponsor's team and clinical / site management CROs.
With a portfolio of over 650 studies, SCiAN's
dedicated teams can step in and support your clinical trials and
clinical development program:
- Study design and protocol development;
- Data management (our CDMS systems offers both EDC and
paper-based solutions);
- Medical monitoring, drug safety / SAE management;
- Biostatistics: all phase I, II and III designs;
- Medical writing (protocol development, CSR writing,
manuscript prepration).
All SCiAN personnel are trained in EDCPRO and
SAEPRO as well as CDMmanager (our
paper based CDMS system) making the transition seamless for
your study, in most indications.
We offer a comprehensive set of data management
services to:
- Launch your study: study design, protocol writing, CRF design,
database build, testing, site training;
- Monitor database security, integrity, and performance
- Monitor data quality and consistency across study sites and
over time as utilized by Coordinators, Monitors, and Data
Managers;
- Perform Medical Monitoring, SAE management;
- Perform central data monitoring to complement site monitoring /
SDV;
- Manage DSMBs;
- Prepare for interim locks and database exports;
- Manage data uploads / imports, coding, SAE reconciliation;
- Prepare for final database lock, audit, release and
archival;
- Generate SAP, TLFs, CSRs.