| Service / Biometrics | |
Biostatistics
Kinship has a dedicated Biostatitistics department for each of its clients. Team of Biostatisticians are available and allocated to each of the clients on need basis. This facilitates our clients to have a dedicated resource for duration of a SAP completion of a single protocol. Our statisticians have experience in the design and analysis of clinical trials ranging from parallel group, cross-over and Bayesian designs to complex (population) Pharmacokinetic- and Dynamic Evaluations, Therapeutic Equivalence Testing and Large variable sample size sequential designs.
Our Biostatistical services can be customized
to your individual needs ranging from SAS programming as per your analysis
plan, to in-depth Biostatistical support of your registration trials.
For registration trials, we can develop optimal designs according to
therapeutic area–specific regulatory guidelines; provide client
representation at IND meetings in support of the designs and analysis
plans and develop full SAPs resulting in a complete “submission-ready”
clinical research report with supporting documentation.
Our
biostatistics services include the following :
Study
design
Analysis
and reporting of pre-clinical and Phase I-IV clinical
trialsof various designs to match the objectives
of the study
Central
patient randomization – fax or web
Periodic
data monitoring and safety reviews
Unscheduled
interim analyses
Post-hoc
and exploratory analyses
Formal
interim and final analyses
Statistical
consulting
Supported by our IT systems and integrated
SOPs, our Biostatisticians are able to accommodate :
Client
defined analysis standards
3rd
party databases
Programming
support for varying reporting formats and standards
Changes
to Protocol, CRF template and project specifications
Timely
response to ad-hoc requests
Collaboration
with 3rd parties for report and manuscript writing
Our flexibility in accommodating changes to project specifications is paralleled with a complete audit trail; while maintaining quality of study data and adhering to expected study timelines.
