our services
Our services range from consultancy, mid-stream activities, analysis & reporting, and third party statistical management to post-reporting, regulatory & HTA submissions.
Study Reporting & Analysis
Our Resource are highly experienced in working with range of outsourced and in-sourced Study Reporting & Analysis services that are flexible and adaptable to your project requirements. Being from Safety reporting to submission package
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Statistical Programming
Development and Validation of Tables, Listings and Graphs. Mapping data in SDTM, Mapping Legacy datasets into CDISC format, Development of ADAM, Preparation of Submission Package, Pooled analysis like ISS, ISE, PSUR, DSUR, RMP, Label update, HTA and more.
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Data Management
CDASH Data standards, Paper CRF, EDC and Mixed options, Edit Checking, Performing Data Triggers, Clinical onsite Study team and data management briefing/Training, Mentoring and implementation of EDC and Quality control review.
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Statistical Activities
Formulation of Research Question & Hypothesis, CRF & Questionnaire Development, Estimation of Power & Sample Size Calculation, Randomization, Preparation of Statistical Analysis Plan, Preparation of Statistical Analysis Plan, Statistical Analysis (Univariate & Multivariate Analysis, Bayesian Methods, Genetic Analysis)
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PK/PD Process
Developing PK/PD datasets, Adapting winolin method, standardising non-mem specification, Generation of Non-Mem datasets, Subject population analysis, Dose proportinality analysis.
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R Expertise
We can develop and validate datasets and TFL, Capable to provide all R Related development supports and solutions, Developing R based tools for DMC and SRT activities, Developing PK/PD process, Subject profiling outputs under development.
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