ClinStatDevice | Consulting, IT and Biometrics for Clinical Research, Founder and CSO Zorayr Manukyan, PhD

ABOUT US

ClinStatDevice (CSD) is your trusted partner in quantitative clinical research solutions. We offer comprehensive support for clinical trial data, including consulting, data analytics, biometrics services, and advanced technology for trial planning, data collection, and real-time monitoring.

Our consulting services provide strategic insights for optimal clinical program strategies, study objectives, and risk mitigation. We have a comprehensive proprietary software suite to cover data collection, trial management and data monitoring. Our specialized software solutions are fully customized for each client’s needs. With a proven track record in complex clinical trials across therapeutic areas like oncology, immunology, infectious diseases, liver diseases, rare diseases, cardiovascular, coagulation, and transfusion medicine, we have achieved numerous successful FDA and EMA submissions in delivery of Phase I–III studies. We look forward to collaborating with you on all design and data aspects of your clinical trials.

WHO WE ARE

SERVICES

The Company adopted risk-based Integrated Management System (IMS) operating within
GxP, HIPAA, GDPR and holds the following standards:

Strategic Consulting

Clinical Development Strategy
Study Design and Optimization
Design Operating Properties
Risk Assessment
Data Integrity
Regulatory Strategy and Compliance

Study Planning

Finalization of Study Design
Risk Mitigation
Study Protocol Input and Review
Statistical Analysis Plan (SAP)
Preparation of Essential Documents
Study Data Monitoring Plan

Analyitcs, Modeling And Simulation

Complex Statistical Modeling
MCMC Simulations
Scenario Planning and Comparisons
Interim Analysis Simulation
Statistical Methodology Development
Predictive Analytics

Biostatistics

Coordinating Biometrics Activities
Data Processing and Reconciliation
Conducting Statistical Analysis
Interim and Final Analysis Execution
Preparation of Study Submission Packages
Ad-Hoc Analysis and Publication Support

Data Management

Database build
Startup activities
Study conduct activities
Database migration
Database lock
Database lock & archiving

Statistical Programming

SAS/R Programming
CDISC Mapping/Conversion, CRF annotation
Development and QC of SDTM and ADaM datasets
TLF development and data Visualizations
Interim or ad hoc analysis support
Reporting for DMC/DSMB activities

SOFTWARE SYSTEM PORTFOLIO

Our comprehensive portfolio is showcasing the cutting-edge expertise and diverse spectrum of services offered by CSD. Explore our ground breaking array of successful projects, innovative trials, and impactful studies that epitomize our commitment to advancing healthcare through deep research, advanced methodologies, and unwavering dedication to scientific excellence including classical analysis methods, machine learning & artificial intelligence.

Dive into our portfolio to witness how we’re shaping the future of clinical research and transforming healthcare landscapes worldwide by providing… clinical data collection and reporting system (EDC or patient registry), centralized patient data monitoring, safety and risk based monitoring platforms, bio-sample tracking management and else.