Scian Services
SCiAN Services is a Contract Research Organization (CRO) providing integrated clinical trial services and data systems with over 30 years of experience. They specialize in IND stage clinical trials across various therapeutic areas including immuno-oncology, gene therapy, CNS, infectious diseases, autoimmune diseases, and diabetes. They support early clinical phase biotechs and mid-size bio-pharma companies with study design, regulatory filing, trial management, data management, biostatistics, and medical writing, utilizing their industry-renowned EDCpro platform.
Industries
Nr. of Employees
small (1-50)
Products
Proprietary electronic data capture platform
A custom-developed EDC platform used to host clinical trial databases, implement eCRFs, manage edit checks, medical coding, SAE handling and data exports in regulatory formats.
Clinical trial data center platform
Hosted clinical data center including modules for trial master file management, integrated safety and efficacy datasets, and SAE database functionality for program-level analyses and archival.
Integrated Safety and Efficacy (ISS/ISE)
CRO services provided by SCiAN to develop data specification plans, integrate and pool safety and efficacy data across multiple studies, generate standardized datasets, and program statistical analysis tables, listings, and figures.
SDTM
CDISC-compliant Study Data Tabulation Model (SDTM) development services including converting legacy databases, creating SDTM datasets, and producing submission packages.
SDTM Validation
Validation of SDTM domains including random data inspection, checks by SDTM programmer, independent programming, and use of Pinnacle 21 or similar software for CDISC and FDA validation rules.
ADaM
Standards for creating analysis ready datasets based on guidelines published by CDISC, featuring ADaM dataset specification development, programming, validation, and submission packages.
Proprietary electronic data capture platform
A custom-developed EDC platform used to host clinical trial databases, implement eCRFs, manage edit checks, medical coding, SAE handling and data exports in regulatory formats.
Clinical trial data center platform
Hosted clinical data center including modules for trial master file management, integrated safety and efficacy datasets, and SAE database functionality for program-level analyses and archival.
Integrated Safety and Efficacy (ISS/ISE)
CRO services provided by SCiAN to develop data specification plans, integrate and pool safety and efficacy data across multiple studies, generate standardized datasets, and program statistical analysis tables, listings, and figures.
SDTM
CDISC-compliant Study Data Tabulation Model (SDTM) development services including converting legacy databases, creating SDTM datasets, and producing submission packages.
SDTM Validation
Validation of SDTM domains including random data inspection, checks by SDTM programmer, independent programming, and use of Pinnacle 21 or similar software for CDISC and FDA validation rules.
ADaM
Standards for creating analysis ready datasets based on guidelines published by CDISC, featuring ADaM dataset specification development, programming, validation, and submission packages.
Services
Operational management of clinical studies including sponsor liaison, project oversight, TMF management and study closeout activities.
eCRF design, database build and configuration, validation and UAT, query management, medical reviews, coding and database lock services for EDC studies.
Study planning, sample size and power calculations, randomization design, SAP authoring, statistical analysis and programmatic delivery of outputs for clinical development programs.
Programming and QC of SDTM and ADaM datasets, development of analysis-ready datasets, TLF generation and delivery in regulatory-ready formats.
Safety surveillance workflows including SAE intake, reconciliation with clinical data, safety database maintenance and safety reporting processes.
Import, transform and reconcile third-party datasets (labs, central vendors) with clinical database records; produce discrepancy listings and manage reconciliation workflows.
Operational management of clinical studies including sponsor liaison, project oversight, TMF management and study closeout activities.
eCRF design, database build and configuration, validation and UAT, query management, medical reviews, coding and database lock services for EDC studies.
Study planning, sample size and power calculations, randomization design, SAP authoring, statistical analysis and programmatic delivery of outputs for clinical development programs.
Programming and QC of SDTM and ADaM datasets, development of analysis-ready datasets, TLF generation and delivery in regulatory-ready formats.
Safety surveillance workflows including SAE intake, reconciliation with clinical data, safety database maintenance and safety reporting processes.
Import, transform and reconcile third-party datasets (labs, central vendors) with clinical database records; produce discrepancy listings and manage reconciliation workflows.
Expertise Areas
- Clinical trial management
- Clinical data management (EDC)
- Biostatistics and statistical consulting
- Statistical programming and dataset standards (SDTM/ADaM/TLFs)
Key Technologies
- Electronic data capture (EDC) systems
- CDISC standards (CDASH, SDTM, ADaM)
- SAS statistical programming
- Clinical data interchange formats (ODM, SAS transport, XML, Excel)
News & Updates
SCiAN announced the delivery of its final webinar on Advanced EDC Trials through XTalks, addressing key aspects of initiating, managing, and closing out an EDC Clinical Trial for biotech or biopharma organizations.
155 Study Designs / Protocol Development
64 studies with IND support
450 Phase Ib, II, and III studies
7 Programs/IMPs: comprehensive support from Phase I to NDA
3 Products through to market approval
SCiAN announced the delivery of its final webinar on Advanced EDC Trials through XTalks, addressing key aspects of initiating, managing, and closing out an EDC Clinical Trial for biotech or biopharma organizations.