Life Sciences Technology Solutions

Delivering quality care experiences that your patients deserve

The need for advanced health care is universal as patients seek high-quality care services anytime and anywhere. To meet this need, the health and patient care industries are calling for a major transformation to strengthen patient engagement.

Saguna Consulting helps you deliver intelligent and connected solutions, sharpening your ability to deliver the care your patients deserve. Our deep industry knowledge encompasses the following technology services and solutions:

laboratory information system

Saguna Consulting offers a state-of-the-art Laboratory Information System (LIS) designed to streamline laboratory operations and enhance the accuracy of diagnostic workflows. Our LIS product supports the full lifecycle of laboratory data management, from test ordering and sample tracking to results reporting and regulatory compliance.

Our LIS key features and offerings include:

Comprehensive Data Management: Our LIS manages all aspects of laboratory operations, including patient records, sample management, results validation, and reporting.
Customizable Workflows: The system is highly customizable, allowing laboratories to configure workflows based on specific operational needs, regulatory requirements, and data security protocols.
Integration with Health Systems: Our LIS integrates seamlessly with hospital information systems (HIS), electronic medical records (EMR), and other healthcare platforms to ensure smooth data exchange and interoperability.
Integration with Laboratory Instruments: Our LIS seamlessly integrates with a wide range of laboratory instruments and devices, enabling automated data capture, reducing manual entry errors, and improving overall operational efficiency in laboratory workflows.
Regulatory Compliance: The LIS is designed to comply with international regulatory standards, including CLIA, CAP, and HIPAA, ensuring data security and patient privacy.
Advanced Reporting Capabilities: The LIS features robust reporting tools that allow laboratories to generate customizable reports on test results, sample tracking, and operational metrics, enabling data-driven decision-making and compliance with regulatory requirements.
Custom Feature Development Services: We offer tailored development services to build custom features and integrations specific to your laboratory’s needs, ensuring that our LIS adapts seamlessly to your unique workflows and technical requirements.

medical writing services

Our medical writing and editorial content services support life sciences organizations in producing high-quality, regulatory-compliant documentation for submissions, clinical trials, and scientific publications.

Our medical writing services include:

Regulatory Submissions: We develop clinical study reports, investigator brochures, protocols, and other key regulatory documents for submission to health authorities, ensuring they meet stringent regulatory standards for approval.
Scientific Publications: Our team helps life sciences organizations prepare peer-reviewed articles, abstracts, and posters for scientific conferences and journals, ensuring scientific integrity and clarity for academic and professional audiences.
Patient-Centered Communication: We create patient-friendly materials such as informed consent forms and lay summaries to ensure complex medical information is easily understood and accessible to patients.
Safety Narratives and Risk Management Plans: We assist in developing safety narratives, risk management plans, and other pharmacovigilance-related documentation, ensuring comprehensive communication of safety data and risk assessments.

digital pharmacovigilance

Saguna Consulting offers a comprehensive suite of digital pharmacovigilance services designed to ensure drug safety throughout the product lifecycle. Our services help life sciences organizations mitigate risks, maintain global regulatory compliance, and safeguard patient health.

Our digital pharmacovigilance services include:

Case Monitoring and Processing: We offer 24/7 adverse event monitoring with automated and manual case processing to ensure timely reporting of serious adverse events (SAEs) and adherence to global regulatory requirements.
Regulatory Compliance and Reporting: Our experts track and interpret evolving global pharmacovigilance regulations (i.e., FDA and EMA), ensuring compliance with reporting standards and submission of periodic safety update reports (PSURs) and development of risk management plans (RMPs).
Corrective and Preventive Actions (CAPA): We implement customized CAPA strategies to address safety issues promptly, reducing risks and improving patient outcomes.

clinical data management

Effective clinical data management is critical for ensuring the success of clinical trials and research. Saguna Consulting offers full-spectrum clinical data management services to streamline data collection, validation, and reporting, while ensuring compliance with Good Clinical Practice (GCP) and global regulatory standards.

Our clinical data management services include:

Data Collection and Validation: We provide secure electronic data capture (EDC) systems to support data collection from multiple trial sites, ensuring data integrity and accuracy.
Database Design and Management: Our custom-built databases are optimized for efficient data processing, storage, and retrieval, supporting clinical trials of all sizes.
Data Analysis and Reporting: We provide real-time insights into trial performance, using advanced analytics tools to accelerate the clinical trial process and reduce timelines.
Risk-Based Monitoring: We offer risk-based monitoring to identify and address data quality issues proactively, minimizing the need for on-site monitoring and reducing costs while maintaining data reliability.

software development for life sciences

Saguna Consulting’s software development expertise extends into the life sciences sector, providing custom software solutions that meet the unique needs of healthcare organizations, biotechnology firms, and medical device manufacturers.

Our software development services for life sciences projects include:

Medical Device Software Development: We design and develop software systems for medical devices that comply with global regulatory standards, such as FDA 21 CFR Part 11 and ISO 13485.
‍Healthcare Applications: We create custom applications for clinical workflows, telemedicine, and patient management, improving efficiency and data integration in healthcare environments.
‍AI and Data Analytics Solutions: Our AI-powered solutions provide predictive analytics, real-time monitoring, and decision-support systems for life sciences research, clinical trials, and personalized medicine.

Ready to deliver an innovative care experience to your patients?

contact Saguna