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:

Oncology studies:
- All solid and liquid tumors
- All phases of clinical studies
Proof of Concept Phase I/II studies.

Scalable Services: fully configured EDC^PRO and SAE^PRO 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.