Solution for Academic and Clinical Researh Groups
"From Concept to Manuscript"
SCiAN's senior consultants can help your team to
create optimal trial designs and develop protocols for your
clinical trials / investigations. SCiAN can address your
protocol development, study design, data
management, biostatistics and manuscript writing needs.
In total, we have worked on more than 50 clinical trials /
investigations in close collaboration with investigators
/ key opinion leaders in a number of indications.
Our consultative services include:
- Protocol development, study design, sample size/power
calculation, statistical considerations, randomization, including
adaptive methods
- Literature review, re-analysis / meta-analysis of reference
studies
- Study planning and implementation
- Study monitoring
- Data management, EDC and SAE reporting
- Central data monitoring
- Statistical analysis - study reports
- Manuscripts - posters - presentations.
Scalable Services Models
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).