Biostatistics Services

KNOWLEDGE, COMPLIANCE, QUALITY & CONVENIENCE @ WORK FOR YOU.. TO DELIVER PROJECT EXPECTATIONS…

At Optimus, our Biostatistics team is experienced and specialises in any and all clinical research related applied biostatistics projects including Design and analysis of clinical trials, Design and analysis of epidemiological studies, Developing statistical and report analysis plans for studies, Quality control, assurance review of statistical documents and Statistical report writing. All of these services are provided according to the latest regulatory requirement.

Our team of experienced statisticians and SAS programmers produce high-quality, timely analysis and reporting of study results across a broad range of therapeutic areas. We have extensive knowledge of study design, statistical methodology, and global regulatory requirements.

Our statistical consulting and analysis experience includes : Sample size estimation; Randomization; Blinding; Tabulation; Descriptives; Correlation and regression; Testing of hypothesis; ANOVA and ANCOVA; Multivariate regression; Logistic regression; Survival analysis; MANOVA; Factor analysis; Cluster analysis; Discriminant function analysis etc., Some of our services in this segment are as follows :

 

BIOSATATS PROGRAM SUPPORTPRESTUDY DEVELOPMENTSTUDY IMPLEMENTATIONSTUDY CLOSURE
Bioavailability, Bioequivalence Studies
Study Design
Interim Analysis
Statistical Analysis
Clinical Trails (Phase I to Phase IV)
Sample Size Determination
Safety Analysis
Statistical Reporting (Summary & Final)
Epidemiology Studies
Statistical Analysis Plan
Vendor Audits/ Due Diligence
Statistical Report Review
SAS Programming
Protocol Review
SAS Programming
Summary Report (ICH E3) Templates

We also provide very focused biostatistics solutions for Bioavailability / Bioequivalence customers and clinical research / development customers, starting from study design, sample size analysis, developing statistical analysis plans, implementing statistical analyses, and statistical reporting writing – all of these services packaged and presented as a unique solution offering “Stats-In-A-Box” integrating people, technology, workflow, regulatory compliance, quality assurance, methodology, standard templates and customised project management.

“Stats-in-a-box” ensures that your fixed costs get converted to a variable cost with the advantage of having projects delivered on-time and at quality standards agreed upon. For more details : Write to Us….

The team at Optimus is flexible to fit your needs. We can provide selected or comprehensive services of this solutions offering as required to meet your specific program needs.

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