Overview: Solutions

Combining Software as a Service (SaaS) technology, and SCiAN's 15 years experience in clinical data management, we are able to offer an extensive library of:

for your phase II-III clinical trials or your complete clinical development program on a monthly subscription basis sponsored by Biotechs / Startups or academic groups or studies managed by clinical CROs.

Our library of fully-configured, indication-specific EDC study databases* cover:

  • Oncology
  • Autoimmune - Inflammatory
  • Cardiovascular
  • CNS - Neurology - Pain
  • Dermatology
  • Diabetes - Metabolic
  • Gastroenterology
  • Infectious diseases
  • Respiratory

 with special focus on:

Scalable Services: fully configured EDCPRO and SAEPRO databases on a monthly subscription basis:

  • Level 1: Hosting of configured study and safety databases - fully managed by Sponsor / CROs
  • Level 2: Hosting of configured study and safety databases - backup on specific data management tasks by SciAn
  • Level 3: Hosting and Management of study and safety databases by SCiAN (a full service model)

Associated data management, statistical analysis and reporting services are described in details under the Services section. Services range from central data monitoring to optimize the use of your resources while maintaining the highest data quality and integrity, through SAE management and reporting to prompt statistical support to address study-emergent safety and efficacy issues and writing final Clinical Study Reports (CSRs).

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* Central to each indication-specific study database is a repository of eCRF forms.  These database libraries have been developped on:

  • Indication-specific clinical standards, such as NCI's Common Data Elements (CDE);
  • CDISC's CDASH (Clinical Data Acquisition Standards Harmonization) specifications;
  • Clinical trial expertise of our pharma and biotech clients.