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Overview
of Services: Pharmaceutical Companies
You will find
our expert Data Management and Biostatistics Departments valuable
resources for your programming, data entry, analysis and reporting
needs. Our services are compliant with ICH, GCP and FDA / Health
Canada guidelines including 21 CFR
Part II. The following is a summary of the services offered
for:
Prospective Controlled Clinical Trials — Observational Studies
— Chart Reviews — Patient Registries — Pharmacovigilance
Trials
- EDC:
Our 21 CFR Part 11-compliant edc system with its intuitive user
interface is used to host your studies on-line. Our EDC solution
is supported with a comprehensive set of data management services,
including coding, medical/science review, central lab data transfers,
DSMB support, on-demand/scheduled data exports/lock; database
audits. 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.
- Large-scale,
traditional data management: double data entry, in-depth data
validation, medical/science review, 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.
- Biostatistics
& Medical Writing / Reporting
Our statistical services can be customized 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.
Unique
Solutions for Exploratory Phase 3b & 4 Studies:
We
understand the importance of clinical trials to our Clients' strategic
objectives. In collaboration with Context we deliver clinical
trial designs that effectively address the sponsor's objectives
in a timely and efficient manner.
Our involvement in the design and execution of a trial allows us
to create the definitive documentation for that study.:
- Strategic
study planning, scientifically credible trial design and clear
protocols
- Effective
trial management and site monitoring covering North America
- Competent
and efficient data management and statistical analysis
- Professional
presentations of the results of clinical trials, including study
reports, manuscripts, posters, presentations and training materials.
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