Biometric Services

A relentless focus on data integrity/quality drives our Clinical Data Management services. Molding our solutions to best fit unique client needs, we take pride in our flexible (and reliable!) services that ultimately breed clinical trial success. Our dynamic team—comprised of seasoned professionals such as technical and clinical data managers, clinical programmers and coders, and lead data managers— offers a wealth of experience spanning multiple therapeutic disciplines.

At the core of our approach? is the construction of clinical studies on validated electronic data capture (EDC) platforms, meticulously selected in accordance with CFR Part 11 compliance standards to ensure not only robust clinical data collection but also its seamless validation, analysis, and presentation. CliniRx strategy goes beyond routine processes to proactively identify and mitigate risks, ensuring smooth trial progression within specified timelines so clients always trust that their projects are in nimble yet capable hands.

Specific clinical data management services include:

• Electronic data capture(EDC) selection and end-user training
• Data cleaning and query management (global, multilingual service)
• Data management and validation plans
• Medical Coding and Drug Coding (MedDRA and WHO DDE)
• Case report form (CRF) design in compliance with SDTM (Study Data Tabulation Model)
• 24x7 Help Desk Support for sites
• Database design in any industry EDC tools, e.g., Medidata RAVE)
• Serious adverse event (SAE) management and reconciliation (Lab,
• Database Testing and User Acceptance Testing
• Database Freeze and Lock
• Data Validation Programming and Testing
• Database Transfer in SAS XPT and EXCEL to relevant stakeholders

CliniRx offers biostatistics services for every clinical trial stage as well as post-marketing endeavors. From the inception of study planning to finalized clinical study report delivery, our expert biostatistician team is intricately involved across the entire spectrum of clinical drug development activities via a comprehensive suite of services including:

• Adaptive protocol design and development
• Statistical analysis plan (SAP) authoring
• Sample size calculation and reestimation (SSR)
• IDMC plans
• Randomization method and algorithm development
• Independent Biostatistician for IDMC and regulatory interactions Determination of NI and equivalence margin
• Clinical endpoint selection
• Clinical study report (CSR) writing support
• Statistical methodology recommendations as per ICH E9 R1
• Tables, Listings, and Figures (TLF) mockups

Plenty of relevant experience makes our Biostatistics team fully equipped to tackle the unique challenges of each trial phase—ensuring efficient, timely delivery—while using industry-standard SAS® software to ensure our data analysis process adheres to stringentstandards and produces robust, reliable results. You can therefore trust us to shore up the statistical backbone of your clinical trials with insights feeding successful and confident decision-making.

CliniRx's Statistical Programming services set out to transform raw clinical trial data into meticulously prepped, regulatory submission-ready analysis datasets. Beyond just specializing in this transformation, we also excel in the Tables, Listings, and Figures (TLF) generation that is so very crucial for comprehensive yet accurate reporting. In doing so, our expert team works diligently to ensure detailed trial data is successfully converted into formats that adhere to regulatory standards.

Our programmers work in close collaboration with the Biostatistics department, adopting a synergistic approach to data interpretation that ensures results undergo rigorous QC measures in the name of precision and reliability; thorough quality checks are thus conducted prior to the final statistical review, reinforcing data integrity and feeding overall clinical trial success.

Moreover, our statistical programming expertise helps us actively contribute to processes assessing the safety/efficacy of investigational products: providing priceless insight into trial hypotheses outcomes via a comprehensive approach underlying clinical trial reporting and streamlining regulatory submissions. Once again, CliniRx shines through as a partner you can rely on to optimize data for compliance purposes and enhance the overall integrity of your clinical trial outcomes.

Our core Statistical Programming services include

• SAS and R programming
• SAS IB and DSUR generation
• CDISC, SDTM, SEND and ADaMcompliant dataset creation, ready for submission
• Dedicated Data Monitoring Committee (DMC), Safety Committee, and Endpoint Committee support
• Tables, Listings, and Figures (TLF) specifically designed for Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE)
• Signal detection and MedDRA up versioning in SAS
• Define.xml generation
• Non-standard and legacy data conversion and database integration