Key to the Successful submission of Clinical trial data to regulatory Authorities is an experienced team with in-depth knowledge of field Standards (CDISC) and statistical analysis methodologies. The core of our team consists of the First and most experienced generations of Statistical programmers in the country who have seen the changes in the industry and work to implement all of the latest advances in data standards. 

• CRF Annotation, Review, and Inputs
• SAP Review and Inputs
• SDTM and ADAM submission-ready package development
• Macro Development
• Support of Data Management for data queries and database edit checks
• PK/PD Dataset Preparation
• Integrated SDTM/ADaM Data Packages (ISS/ISE/ISI) Preparation
• Creation of Patient Profile/Narratives 
• Complex time-to-event analysis
• Project/Study/Company level macro program creation
• Data Exploration and Programming Automation
• Safety Reporting: (IA, PSUR, DSUR, iDMC, DSMB)
• CDISC Documentation (including Define.xml, regulatory-savvy deliverables)
• Full range of statistical methods: 
• Refined descriptive and inferential statistical analyses
• Advanced linear and nonlinear modeling prowess 
• Intricate generalized linear model construction models 
• Nuanced categorical data examination
• Complex time-to-event analysis
• Nonparametric methods 
• Equivalence and non-inferiority methods 
• Data imputation 
• Cutting-edge nonparametric assessments
• Methodologically sound equivalence and non-inferiority analyses

With comprehensive expertise spanning all phases and diverse therapeutic areas in drug development, our skilled programmers seamlessly integrate into client project teams or spearhead the formation of new ones. Cultivating enduring partnerships, we bring invaluable insights to every collaboration. 

R programming team not only showcases exceptional proficiency in mastering a diverse array of R packages and tools but also consistently upholds a superior standard of professionalism by meticulously adhering to the intricate guidelines set forth by CDISC standards. This commitment ensures that our team maintains a rigorous approach to data management and analysis, aligning seamlessly with the stringent requirements of clinical research and regulatory compliance.

We demonstrate proficiency in utilizing a variety of R-specific packages for data manipulation and visualization while adhering to CDISC standards. Our capabilities extend to various clinical programming activities and refined statistical analyses, ensuring thoroughness and compliance throughout the data management and analysis process.

• Protocol/ Sample size review
• CRF (Case report form)/DVM (data validation manual)
• SAP (statistical analysis plan) - text and mock shells development
• Statistical SDTM/ADAM and TLF review
• Review of the statistics section of the CSR (clinical study report)
• Interim Analysis/Data Safety Monitoring Boards (DSMBs)
• Project management (timelines, meetings/DRM- data review meeting)

At Gurus, we pride ourselves on our unwavering commitment to delivering excellence across all aspects of our operations. Our dedication to quality is not just a commitment; it's a cornerstone of everything we do. With a global presence and a diverse range of services, we uphold the highest standards of quality to ensure customer satisfaction, regulatory compliance, and operational excellence. Our biostatistical department can offer a wide range of solutions tailored to the needs of clients. Here are some specific solutions:

Ensuring Absolute CDISC Compliance for Your Data

Gurus enhances clinical data quality by ensuring full CDISC compliance and comprehensive validation, all within your budget and timelines. According to Clinical Data Interchange Standards Consortium (CDISC) guidelines, we understand the significance of standardizing study data. Our team skillfully applies all CDISC standards and stays updated with FDA submission requirements to streamline implementation and facilitate efficient regulatory review.

Ongoing Study Data/Legacy Data Conversions to SDTM Standards.

• Annotating CRFs (aCRF.pdf)
• Creating SDTM mapping specifications.
• Converting legacy raw datasets to SDTM datasets.
• Generating SDTM define.xml.
• Conducting SDTM compliance checks (OpenCDISC/Pinnacle 21)
• Creating/Reviewing SDTM Reviewer's Guide (SDRG).

ADaM Standards.

• Developing ADaM specifications.
• Creating ADaM datasets.
• Generating ADaM define.xml.
• Conducting ADaM compliance checks (OpenCDISC/Pinnacle 21)
• Creating ADaM Reviewer's Guide (ADRG).

Our team is committed to staying abreast of all industry updates and actively participates in CDISC events, including trainings and workshops. Internally, we organize training sessions and discussions to address complex questions and solutions, ensuring our services remain at the forefront of industry standards.

The Gurus is a fast-growing company assembling highly qualified professionals in the industry. We deliver Clinical Statistical Programming, Clinical Data Management, and Biostatistics services to worldwide renowned CROs and Pharmaceutical companies. We have the biggest and most experienced Team of Statistical Programmers across Armenia. Since its establishment company is organizing SAS Base trainings in the whole territory of Armenia for replenish own Team by requested quality.

The Gurus is a fast-growing company assembling highly qualified professionals in the industry. We deliver Clinical Statistical Programming, Clinical Data Management, and Biostatistics services to worldwide renowned CROs and Pharmaceutical companies. We have the biggest and most experienced Team of Statistical Programmers across Armenia. Since its establishment company is organizing SAS Base trainings in the whole territory of Armenia for replenish own Team by requested quality.

The Gurus is a fast-growing company assembling highly qualified professionals in the industry. We deliver Clinical Statistical Programming, Clinical Data Management, and Biostatistics services to worldwide renowned CROs and Pharmaceutical companies. We have the biggest and most experienced Team of Statistical Programmers across Armenia. Since its establishment company is organizing SAS Base trainings in the whole territory of Armenia for replenish own Team by requested quality.

The Gurus is a fast-growing company assembling highly qualified professionals in the industry. We deliver Clinical Statistical Programming, Clinical Data Management, and Biostatistics services to worldwide renowned CROs and Pharmaceutical companies. We have the biggest and most experienced Team of Statistical Programmers across Armenia.