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Data Management
Our cost-effective data management services include double data
entry, in-depth data validation, medical/science review of CRFs,
coding of AEs and medications, integrating central laboratory data,
periodic data exports, database lock, database audit and database
release in SAS and/or in XML, as per CDISC specifications.
EDC
Our secure and 21 CFR Part 11-compliant edc system with its intuitive
user interface is used to host your studies on-line. Key benefits
include rapid deployment, flexible study configuration for all phases
of trials, comprehensive on-line data validation, rapid change management,
and experienced user support. Our system and services ensure analysis-ready
data at any time.
Biostatistics
& Medical Writing / Reporting
Our statistical services can be customized to your individual needs
ranging from SAS programming as per your analysis plan, to in-depth
biostatistical support, including industry standard clinical study
reports (ICH report as per FDA's CTD). Other statistical services
include study design, protocol-writing (statistical sections), sample
size estimation, randomization (list / code envelops, central /
adaptive randomization), managing DSMBs, ISS and ISE analyses and
reports.
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