General Introduction
Inference Systems is a well focused CRO (contract research organization) providing high precision, quantitative, digital image analysis and clinical Informatics services to support pre-clinical and clinical research.
The management and employees of the company have over 50 years of combined experience of working within the R&D frameworks of medium and large Pharma companies and provide the type of high quality services.
Right from the onset, we deployed qualified professional and specialists to present host of unique services to benefit numerous businesses.
We offer all end to end clinical data management and analysis services:
- Clinical Data Management.
- Data Analysis and Programming.
- CDISC Migration.
Clinical Data Management
Challenges in clinical data management have only complicated the job of pharmaceutical, medical companies and biotechnology, mounting them with more challenges in terms of product marketing and regulatory adherence. This has apparently called for a fitting solution that would best fit the challenging scenario, without sounding costlier to businesses.
After studying all the factors that complicated things and employing our proficiency, we at Inference System India have come with customer-centric and all-around Clinical Data Management Services. Our services offer you a futuristic approach in conducting clinical trials and are way advanced in enhancing your productivity and efficiency levels. So Inference System India is a company that provokes you to get rid of the conventional systems and get ready for a next generation experience.
Data Analysis and Programming
Data Analysis and Reporting have always been a key component of our services as part of our legacy. Our team has experience in all phases of drug research and development from pre-clinical to clinical and post-marketing support across a broad range of therapeutic areas.Inference System provides all round support from protocol design through to study level sample calculations, analysis of Tables, Listings and Figures.
Inference System’s data analysis and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver the unparalleled statistical output required for every aspect of drug development including the statistical material you need for clinical study reports and for applicable regulatory requirements.
Our qualified Programmers apply their insightful regulatory knowledge to help you steer the intricacies of study design, sample size, data listings, analysis methods and interpretations.
CDISC Migration
Understanding and complying with CDISC data standards is critical to satisfying regulatory data submission requirements. Inference System has a professional team of with strong technical understanding in Study Data Tabulation Model (SDTM) analysis Data Model (ADaM), CDISC
terminologies, corresponding implementation and Reviewers’ guides and the related applicable regulations.
We design Clinical Data Acquisition Standards Harmonization (CDASH) compliant CRFs for paper-based and electronic data capture (EDC) clinical trials, allowing us to offer our clients with SDTM compliant data models in early phase of development.
Inference System leverages its expertise in statistical analysis and strategic consulting to offer CDISC-compliant Analysis Data Model (ADaM) data for statistical analysis to compliment Integrated Summaries of Safety and Efficacy.