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.

 

 

EXPERIENCE HIGHLIGHTS

  • 148 INDs supported (trial designs)
  • 235 study databases delivered
  • 104 CSRs for submission to FDA, EMEA
  • Clinical Advisory Boards: 24
  • Our Clients' success (NDA or out-licencing): 15

NEWS - LINKS

SCiANEWS Publications:

Techniques for Designing Case Report Forms in Clinical Trials (2006), Kyung-hee Kelly Moon

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