Integrated TEAM - STANDARDS - SYSTEMS

Key to our success is our integrated services and systems developped over hundreds of IND-stage clinical trials and delivered to you in the hand of experienced and motivated full-time data management, biostatistics and drug safety professionals supported by our senior project oversight group.

Therapeutic Area

In-depth experience in Oncology, Autoimmune diseases, CNS, Infectious diseases, Cardiovascular,  Dermatology, Diabetes - Metabolic, Gastroenterology, and Respiratory.

Comprehensive Data Services

As a North American contract research organization, trial design, 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:

  • Trial design and clinical development program planning;
  • Data management using SCiAN's EDCPRO or 3rd-party / OTS systems;
  • Medical monitoring, drug safety / SAE management (using SAEPRO);
  • DSMBs / DMCs
  • Annual IND Safety Updates;
  • Biostatistics: all phase I, II and III designs; 
  • Medical writing (protocol development, CSR writing, manuscript prepration);
  • NDA support (ISSE, regulatory representation).

 Systems

All SCiAN personnel are trained in EDCPRO, SAE PRO, TMFPRO and ISEPRO making the transition to our systems seamless for your study.

 

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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