|
 Overview
Clinical Data Services is a rapidly growing domain in the
industry. All the major pharmaceutical companies invest
billions of dollars each year in research and development of
the new drugs. This involves testing of potential drug
compounds on animals, healthy volunteers and actual patients
by conducting clinical trials. A huge amount of data is
collected in these trials and then this data is cleaned,
transformed and analyzed to extract meaningful information
and the results are presented to the regulatory authorities.
Choosing a right business partner to provide Clinical Data
Services is extremely important as it requires a lot of
expertise in analyzing the trial results correctly within
strict timelines as any delay in the process would mean that
ailing patients would be deprived of treatment/cure for a
longer time.
GCE Solutions has vast experience in providing clinical data
services to leading clients. Our consultants are industry
recognized professionals with experience in Clinical Data
Management and Clinical Statistical Programming and
Analysis. We have proven expertise in providing clinical
programming and analysis support for Oncology, Neuroscience,
Cardiovascular, Specialty Care and Primary Care therapeutic
areas.
GCE's
Offering
Below are the activities GCE professionals have been
performing for our Pharmaceutical Clients as part for
Clinical data services :
Protocol Development
·
Statistical planning (sample size
estimation, randomization, and power calculations)
·
Complete protocol development
·
Literature review and
meta-analysis
·
CRF completion guidelines
Programming Planning
·
Define edit check specifications,
database and database views
·
Annotate CRF with SAS views and
SAS dataset variable names
·
Create data definition documents
·
Program Protocol Deviations
·
Protocol deviation listing
·
Provide input into SAS and review
SAP
·
Develop Programming Plan
·
Develop data mapping plan
·
Create plan for reusable macro
library
Program Development
·
Set up and run data extraction
programs
·
Program figures, tables and
listings
·
Create physical data model
document
·
Create mock tables
·
Develop, test and validate
programs to produce figures, tables and listings, data
mappings and extracts
·
Create and validate reusable
components
Quality Control
·
Develop QC Programming Plan
·
Perform QC of published tables,
SAS datasets and algorithms
·
Produce QC
documentation
·
Create independent programs to
validate the results
Production of Tables, Listings, Figures and Datasets
·
Provide input to or review
interim analysis plan
·
Produce tables, listings and
figures and datasets for interim analysis
·
Produce reporting datasets
·
Issue draft/blinded tables
·
Issue protocol deviations
·
Produce and issue final tables
·
Produce electronic submission (ESUB)
components
Project Management
·
Metrics collection
·
Estimation models
·
Process Improvements based on
quantitative data analysis
·
Root Causal and Defect Analysis
Why GCE
The following key value differentiators explain why GCE is
the right choice for providing Clinical Data Services :
·
Strong Vision specific to SAS Clinical Data
Services– To become most trusted and cost effective partner,
establish long term partnership with Pharma Clients in areas
of Statistical Analysis and Clinical Data Management
·
0% attrition in 06’- 07, major
challenge for many companies proving SAS Clinical Data
Services
·
90% of GCE consultants have over
5 years of SAS Pharma experience
·
GCE Consultants have prior experience with major
pharmaceutical companies with understanding of Pain Areas,
Culture and work dynamics
·
GCE consultants have excellent
experience in working on onsite, near site and offshore
models
·
Experienced mix of resources with
SAS, Clinical and Statistical backgrounds
·
Diversity – Our workforce is mix
of American, Indian, Chinese employees
·
Ability to set up
near-site/offsite/offshore centers to provide competitive
cost advantage
·
Dedicated support from GCE SAS Center of
Excellence ( Dedicated pool of experts with prior experience
in top companies manage this practice)
·
Metrics based delivery model, an ability to map
the GCE’ Project Management processes to client Processes
·
Strong focus on Quantitative and
qualitative data collection for continuous improvement
·
High focus on competency building
( All GCE SAS consultants are SAS certified)
·
Communication protocol (including meeting
schedules, feedback and escalation processes) as well as
roles and responsibilities clearly defined
·
Continuous assessment – against
goals and industry standards and processes to fix gaps
·
Continuous training program
designed specifically for Clinical SAS |
