Life Sciences Technology Solutions
Sky Nexus delivers advanced technology solutions for the life sciences industry, enabling pharmaceutical development, clinical research, regulatory compliance, and biomanufacturing through integrated platforms and data analytics that accelerate innovation while ensuring quality and compliance.
Industry Overview
The life sciences industry encompasses pharmaceutical development, biotechnology research, medical devices, and diagnostics—all requiring sophisticated technology solutions to accelerate innovation, ensure regulatory compliance, and maintain the highest quality standards. Sky Nexus provides comprehensive platforms that support the entire drug development lifecycle from discovery through commercialization.
Our solutions enable life sciences organizations to manage clinical trials, ensure GxP compliance, optimize manufacturing processes, and leverage advanced analytics for drug discovery and development. We specialize in validated systems that meet FDA, EMA, and TGA requirements while providing the flexibility needed for rapid innovation in pharmaceutical and biotechnology research.
With expertise spanning drug discovery, clinical development, regulatory affairs, and biomanufacturing, Sky Nexus helps organizations accelerate time-to-market while maintaining rigorous quality and compliance standards throughout the product lifecycle.
Life Sciences Solutions
Clinical Trial Management
Comprehensive clinical trial management systems (CTMS) supporting study planning, site management, patient recruitment, and regulatory compliance throughout clinical research.
- Study planning and protocol management
- Site and investigator management
- Patient enrollment and tracking
- eTMF and regulatory documentation
Electronic Data Capture
Advanced EDC systems for clinical data collection, validation, and management with real-time monitoring and query management capabilities.
- Electronic case report forms (eCRF)
- Real-time data validation and queries
- Source data verification (SDV)
- 21 CFR Part 11 compliance
Regulatory Affairs Management
Comprehensive regulatory information management systems supporting global submissions, compliance tracking, and regulatory intelligence.
- Regulatory submission management
- Labeling and artwork management
- Global registration tracking
- Regulatory intelligence and monitoring
Biomanufacturing Solutions
Advanced manufacturing execution systems for biologics production with GMP compliance, batch record management, and process analytical technology integration.
- Electronic batch records (EBR)
- Process analytical technology (PAT)
- Cell culture and fermentation control
- GMP compliance and validation
Drug Discovery Analytics
AI-powered analytics platforms for drug discovery, target identification, and compound screening accelerating research and development timelines.
- AI-driven target identification
- High-throughput screening data management
- Molecular modeling and simulation
- Research data management
Laboratory Information Management
Comprehensive LIMS solutions for quality control, analytical testing, and sample management in pharmaceutical and biotech laboratories.
- Sample tracking and chain of custody
- Method management and validation
- Instrument integration and data capture
- Certificate of analysis generation
Life Sciences Sectors
Pharmaceutical Development
Technology solutions supporting small molecule drug development from discovery through commercialization with regulatory compliance and quality assurance.
- Drug discovery and optimization
- Formulation development
- Clinical trial management
Biotechnology
Specialized systems for biologics development including monoclonal antibodies, gene therapies, and cell therapies with advanced manufacturing control.
- Biologics manufacturing
- Cell and gene therapy production
- Bioprocess optimization
Medical Devices
Technology solutions for medical device manufacturers including design controls, quality management, and regulatory compliance systems.
- Design control and DHF management
- Device history record (DHR)
- Post-market surveillance
Diagnostics
Technology platforms for diagnostic test development, laboratory operations, and result reporting with quality assurance and regulatory compliance.
- Assay development and validation
- Laboratory automation
- Result reporting and analytics
Life Sciences Success Stories
Clinical Trial Management Transformation
Implemented integrated CTMS and EDC platform for mid-sized pharmaceutical company, accelerating clinical development and improving data quality across global trials.
Biologics Manufacturing Platform
Deployed comprehensive biomanufacturing solution for biotech company producing monoclonal antibodies, achieving FDA approval for commercial manufacturing.
Ready to Accelerate Your Life Sciences Innovation?
Contact us today to discuss how Sky Nexus can help you implement technology solutions that accelerate drug development, ensure regulatory compliance, and drive innovation in your life sciences organization.
