Services Offered to Multinational Pharmaceutical Companies Attention: DATA MANAGEMENT, BIOSTATISTICS & INFORMATION SYSTEMS DEPARTMENTS SciAn has the expertise and breadth of experience to support your research efforts. You will find our expert data management and biostatistical departments valuable resources for your programming, data entry, analysis and reporting needs. Our services are compliant with ICH, GCP and FDA/TPD guidelines including 21 CFR Part II. The following is a summary of the services: |
| Data
Management / Electronic Data
Capture (EDC) Traditional method (double entry from CRFs) or remote data entry over the internet or over dedicated connections using our proprietary and fully compliant data management software. Industry standard data review and "cleaning" procedures according to our SOPs or your specifications. Documented databases (ASCII and SAS files) and files for merging into your integrated safety database will be provided. Biostatistics Our statisticians and programmers can design (plan approved by you) and carry out the analysis required by the protocol using SAS (ICH guidelines and your SOPs will be followed). Reporting We will prepare integrated research reports (as per ICH guidelines and/or your SOPs), manuscripts and presentation materials. |
View our services in more detail. View how our services comply with all regulatory guidelines. We look forward to collaborating with you in the near future, please contact us. |
 |