Life Sciences Software Development Services
ScienceSoft designs compliant software platforms for CROs, R&D teams, and device manufacturers. Our systems streamline trial and lab operations, connect with legacy systems and modern lab instruments, and support fast reconfiguration for evolving research areas.
Life sciences software development services cover the design, implementation, support, modernization, and evolution of solutions for clinical trials, lab research, and device-based diagnostics. We develop software ecosystems that digitalize and orchestrate all key operations from subject data capture or sample management to assay automation, site monitoring, and regulatory reporting.
Life sciences software includes:
- Clinical trial solutions, such as CTMS, EDC, CDMS, IRT, eTMF, eConsent, patient portals, etc.
- Laboratory systems for research environments, such as LIMS, ELN, SDMS, LES, QMS, etc.
- SaMD and software for medical devices (diagnostic assistants, software for wearable devices, chronic care platforms, etc.).
According to Indegene’s 2024 survey, top IT investment priorities for life sciences companies are developing cloud infrastructure, AI/ML adoption, and automating operations. We address all three with ready-to-scale cloud architectures, embedded AI for trial and lab automation, and modular workflows that adapt without code rewrites. Check our life sciences projects to see how biotech, lab, and medical device companies benefit from these capabilities.
Off-the-shelf software often fails to support specialized workflows, instruments, and data formats used in modern clinical research and lab environments.
Custom life sciences software helps overcome these limitations by:
- Enabling protocol- and assay-specific automation: ingesting nonstandard molecular data formats (such as vendor-specific FCS, FASTQ) or supporting region-specific regulatory fields.
- Supporting modern lab infrastructure: integrating with high-throughput analyzers, sequencing platforms, or proprietary equipment APIs.
- Ensuring interoperability: connecting to legacy systems and third-party vendor platforms via event-driven integration layers to eliminate data duplication and manual synchronization.
- Accelerating adaptation to changes: allowing teams to modify workflows or forms without IT staff involvement when clinical trial protocols or SOPs change.
Why Choose ScienceSoft for Your Life Sciences Software Initiative
- Since 2005 in healthcare software development.
- 150+ successful projects in the domain.
- Since 1989 in data analytics, data science, and AI.
- Expertise in healthcare data exchange standards (FHIR, HL7), terminology and coding standards (ICD-10, CPT, LOINC, SNOMED, RxNorm), and medical imaging standards (DICOM).
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Experience with patient data access and interoperability requirements (USCDI, CCDA, 21st Century Cures Act).
- Experience in meeting regulatory (HIPAA, GCP, GLP, FDA 21 CFR Part 11, GDPR) and interoperability (USCDI, CCDA, 21st Century Cures Act) requirements.
- Architects with 10–20 years in healthcare IT, to design scalable, secure, and interoperable clinical trial platforms.
Our awards and partnerships

Featured among Healthcare IT Services Leaders in the 2022 and 2024 SPARK Matrix
Named among America’s Fastest-Growing Companies by Financial Times, 4 years in a row
Recognized on Newsweek’s 2025 America’s Most Reliable Companies List
Recognized by Health Tech Newspaper awards for the third time

Top Healthcare IT Developer and Advisor by Black Book™ survey 2023
Named Best in Class in Medical Device Connectivity by Frost & Sullivan (2023)
Listed in IAOP’s 2025 Global Outsourcing 100 for the 4th year running
ISO 13485-certified quality management system
ISO 27001-certified security management system
Life Sciences Solutions We Develop, Maintain, and Enhance
Clinical trial execution and oversight
Orchestrate patient enrollment, visit scheduling, and site operations. Supports budget control and real-time trial performance tracking via custom KPIs and flexible role-based dashboards.
Electronic data capture (EDC) systems
Capture structured trial data from eCRFs, wearables, labs, and other sources. Flag inconsistencies with built-in logic and support data cleaning and issue resolution via query workflows.
Consolidate data from internal and external trial systems, harmonize terminology (e.g., MedDRA, CDISC), and prepare analysis-ready datasets with traceable processing history.
Supports patient randomization, treatment group assignment, and IP dispensing. Automates IP inventory control and logistics via integration with a supply chain system.
eConsent software
Enables remote informed consent workflows, including review and signing. Supports consent document version control and role-based approvals aligned with regional regulations.
Capture treatment outcomes via configurable forms. Support remote and on-site data entry with branching logic, tracks adverse events, and automates treatment compliance monitoring.
Consolidates operational metrics across sites, detects protocol deviations and compliance gaps in real time, and assesses risks. Supports remote site visits and other CRA workflows, such as corrective action management.
Pharmacovigilance systems
Support end-to-end adverse event management: case collection, triage, causality assessment, signal detection, and report generation for regulatory submission. Detect and assess safety signals. Prepare routine safety reports.
Organizes and versions trial documentation from all parties, monitors submission progress, and maintains inspection readiness through automated quality checks and quality review workflows.
Regulatory information management (RIM) systems
Coordinate multi-country submission processes, manage regulator communications, and monitor approval timelines. Support structured document templates and status dashboards.
Combine operational, safety, and data quality metrics for centralized trial monitoring. Support early risk detection and performance trend analysis with built-in self-service tools.
Patient recruitment solutions
Use EHR data to match patients to trial eligibility criteria and perform prescreening. Support outreach automation and track recruitment effectiveness with site- and channel-level insights.
Research laboratory operations
Manage the full lifecycle of lab samples, from registration to utilization. Integrate with lab instruments for automatic data capture and support workflows for quality control and inventory management.
Enables experiment design and execution, automatic result capture, and research data analysis. Provides tools for molecular data processing and collaborative authoring of protocols and reports.
Integrates with laboratory analyzers to collect and process test data. Generate test reports and support rule-based interpretation of findings to assist diagnostic decision-making.
Laboratory execution systems (LES)
Guide personnel through SOP-compliant workflows, capture instrument output in real time, and generate traceable execution logs. Validate reagents, sample expiration date, and equipment status before each run.
Quality management systems (QMS)
Maintain SOP and compliance documentation, log QC results, and track deviations. Support CAPA management, equipment validation, staff training, and audit preparation.
Scientific data management systems (SDMS)
Aggregate raw and processed data from instruments, LIMS, and ELN. Tag records with metadata and store them in a centralized repository to support search, structured querying, and downstream analysis.
Analyzes consolidated lab data in real time. Identifies patterns in experimental outputs, monitors KPIs, performs root cause analysis for SOP deviations, and suggests corrective actions to maintain process quality.
Direct-to-patient (DTP) services
Support participant enrollment, eConsent management, and access to study materials. Enable patients to report symptoms remotely, receive visit reminders, and communicate securely with trial staff.
Stream biometric data from wearables and home devices to trial systems. Detect out-of-range values, analyze trends, and provide inputs for adverse event monitoring and assessment workflows.
Patient assistance program portals
Automate eligibility verification for assistance programs and manage the distribution of co-pay cards, free medications, or bridge therapies. Maintain audit logs for product delivery and financial transactions.
Enable patients to receive personalized dosing alerts, refill reminders, and secure nurse messaging. Include structured self-reporting for symptoms and side effects, educational materials, and optional chatbot interfaces.
Coordinates in-home care delivery, including nurse visits and direct-to-home medication supply. Streams wearable data to remote care teams and supports digital or human coaching for better treatment adherence.
Support virtual consultations, e-prescriptions, and medication delivery. Enable remote clinical trial activities, including consent collection and visits, as part of decentralized or hybrid study designs.
Medical device software
Processes and transmits patient vitals, diagnostic, or therapy data to cloud platforms. Commonly includes AI-based clinical decision assistance and integrates with EHR and other healthcare systems for data exchange.
Collects continuous physiological data and streams it to clinical systems or research platforms. Provides personalized recommendations via patient-facing mobile apps and structured outputs for healthcare provider analysis.
Run on-device logic for real-time data processing and execution of clinical tasks, such as insulin dosing or spirometry test guidance. Synchronize results with external systems and provide user feedback through built-in displays or mobile interfaces.
Monitors the location and usage of RFID-tagged medical equipment and supplies across facilities. Automates availability checks and usage scheduling. Optimizes resource utilization and triggers preventative maintenance.
Captures patient-reported health data and wearable output for remote monitoring and care coordination. Provides tools for prescription management, treatment adherence tracking, and patient education and support.
Acquires and processes imaging data (CT, MRI, ultrasound, etc.). Supports tissue segmentation, volumetric analysis, and lesion detection. Integrates with PACS/EHR and enables AI-driven disease staging and outcome prediction.
Supplementary software for life sciences companies
Registers incoming materials using barcode or RFID input. Monitors stock levels, storage conditions, and expiration dates in real time. Automates reorder workflows and maintains audit logs for inventory movements and usage history.
Predicts supply needs, plans procurement, and supports the vendor selection process. Automates accounting and financial document exchange with suppliers, tracks order and shipment statuses, and analyzes procurement efficiency and spend patterns.
Provide suppliers with a self-service interface to access requirements, submit proposals, and participate in tenders. Support ERP integration for real-time catalog updates, order processing, and document exchange across systems.
Consolidate data across procurement, inventory, finance, and CRM systems. Calculate operational and supplier performance metrics, identify supply chain disruption risks, and generate data-driven recommendations for optimization.
AI Capabilities for Life Sciences Software
ScienceSoft enhances life sciences software with embedded AI capabilities, such as natural language processing, speech recognition, computer vision, predictive analytics, and agentic AI. Each AI component we deliver operates within a validated sandbox, supports explainable outputs, and integrates with compliance audit trails. We follow a phased AI adoption approach to ensure early ROI and regulatory compliance, as recommended by industry leaders, e.g., KPMG, in their recent report.
We recommend starting with narrow-scope AI agents for high-impact routine tasks, e.g., an investigator assistant for visit scheduling and document drafting. Early use cases like this deliver measurable ROI and help define internal AI governance (how AI actions will be traced, validated, and controlled to meet regulatory expectations).
However, already at this stage, it’s important to ensure the architectural design is scalable for future growth. Our architects achieve this by embedding AI into modular workflows. From there, more advanced use cases can be added safely and incrementally.
Our life sciences clients consider the following AI use cases to be most impactful for automating trial and lab operations, raising research productivity, and cutting trial duration and costs.
Use cases for life sciences R&D organizations
Investigator AI assistant
Schedules investigator tasks, drafts site documents (e.g., adverse event reports), and suggests protocol-compliant task flows. Works within CTMS and eTMF systems using trial calendar, site data, and regulatory templates. Logs all recommendations and actions for review by study coordinators.
Trial participant AI chatbot
Engages with participants in natural language, answers trial-related questions, and sends reminders for medications, diaries, and visits. Operates via a mobile app or a patient portal and syncs with CTMS and eCOA to exchange patient health and engagement data.
Clinical data management agent
Detects research data defects, creates and manages EDC queries for data cleaning, and assembles analysis-ready datasets. Operates as a layer over CDMS and EDC platforms.
Site monitoring AI assistant
Analyzes trends in site submissions and visit logs to detect protocol deviations and compliance risks. Embedded in CRA dashboards and remote monitoring systems. Provides risk scoring, deviation summaries, and corrective action recommendations.
Pharmacovigilance AI engine
Automates adverse event case collection, tracking, and reporting. Identify and assess safety signals. Extracts structured data from narratives and prepares MedDRA-coded reports for regulatory submission. Integrated with safety systems and compliant with ICH E2B(R3) requirements.
Submission documentation writer
Generates submission documents (e.g., study reports, tables, listings, and figures) from trial databases according to regional regulatory guidelines (e.g., FDA, EMA). Automatically checks output quality and performs version control.
Clinical trial design assistant
Analyzes historical trial performance, patient eligibility data, and endpoint metrics to optimize protocol design. Drafts protocols, predicts likely amendments, and estimates feasibility. Operates alongside CTMS trial planning tools.
Trial start-up engine
Forecasts site recruitment efficiency and assists in site eligibility evaluation. Generates localized informed consent documents and assembles site initiation packs. Integrates with CTMS and eTMF.
Use cases for life sciences R&D laboratories
AI-powered lab assistant
Enables natural-language data querying from ELN and SDMS, generates scripts for experiment automation, and captures voice notes. Drafts experiment plans and standardized research reports. Connects to ELN and SDMS and complies with lab change control and data access protocols.
AI for experimental data analytics
Processes high-volume molecular data, e.g., from sequencing, flow cytometry, or mass spectrometry. Detects patterns, flags anomalies, and outputs annotated datasets with statistical overlays. Embedded in SDMS, LIMS, or ELN pipelines, with parameterized control and result versioning.
AI use cases for medical device software
AI diagnostic assistant
Analyzes DICOM images and physiological data from connected devices. Interprets findings, suggests diagnoses, and alerts about high-risk patient conditions. Embedded in SaMD platforms or medical imaging software and integrates with PACS.
AI for chronic disease management
Continuously assesses patient health status based on wearable output and self-report diary data. Supports and educates patients, assists clinicians in treatment adjustment, and automates activity scheduling. Integrates with RPM and patient engagement apps, with compliance controls for data and suggestions.
Services We Offer for Life Sciences Companies
Consulting on life sciences software implementation
ScienceSoft’s consultants analyze your research, operational, and compliance needs to define optimal functional scope, architecture, and integration strategy. We advise on AI-enabled workflow automation, legacy integration, and cloud adoption paths, and provide detailed project roadmaps with accurate budget and timeline estimates.
Custom life sciences software development
We provide end-to-end development of clinical trial, lab informatics, medical device, and direct-to-patient software designed around your operational workflows. Our teams handle integration with existing infrastructure, validation against applicable regulatory standards, and comprehensive documentation for audit readiness.
Low-code development for cost-effective feature delivery
We use low-code tools (e.g., Power Apps) to enable fast delivery of software configuration tools, such as workflow builders or form editors. These modules are isolated from core logic and validated independently, allowing protocol or assay changes to be implemented without full system re-certification. Admin users can manage updates under role-based controls and change tracking.
Legacy software modernization and evolution
We integrate legacy lab or trial platforms with new lab instruments and clinical data sources, and extend them with modern components, such as AI engines, new data formats, and cloud services. We enable phased migration to the cloud while maintaining compliance logs, data integrity, and uninterrupted operation of regulated workflows. Legacy adapters preserve existing SOPs and change approval logic.
Life sciences software support
We provide 24/7 support covering infrastructure, application, and compliance layers. Our L1–L3 teams resolve user issues, perform ongoing validation of AI modules, and maintain up-to-date compliance documentation (e.g., SOPs, risk logs, validation reports). All software changes are routed through controlled review and re-validation cycles.
Discuss your project with a life sciences IT consultant
Want to improve data quality, ensure regulatory traceability, and enable automated, scalable research workflows? Request a free call with our consultants, who are experts in healthcare IT and have experience in life sciences software projects.
Architectural Principles Behind Our Life Sciences Solutions
As a life sciences software development company, ScienceSoft builds solutions that minimize change risk, simplify regulatory compliance, and support scalable, modular growth. Below, we share the key architectural principles behind our systems.
If you're looking for example architectures, you can check the pages of individual applications, e.g., connected medical device solutions and software for smart medical devices, as well as the pages dedicated to a clinical trial software ecosystem and a lab software ecosystem.
Compliance-first system design
Our compliance-first architecture embeds regulatory adherence into every system layer, which reduces the cost of validation, prevents audit issues, and enables faster rollout of compliant updates. Depending on the software type, we address the following core sets of regulations and standards:
- Clinical trial and R&D systems: GCP, FDA 21 CFR Part 11, HIPAA, GDPR, 21st Century Cures Act.
- R&D laboratory software: GLP.
- Medical device and SaMD software: IEC 62304, ISO 13485, ISO 14971, EU MDR/IVDR.
To support these requirements, we establish a dedicated compliance layer with reusable system-wide components. Its basic features typically include the following.
- Access control and traceability: Role-based permissions, MFA, and full audit logging across all user actions and API calls. Ensures inspection readiness and forensic traceability.
- Change-controlled configuration: Forms, workflows, and validation logic are isolated in versioned modules. All updates pass through review and approval cycles, minimizing revalidation scope.
- End-to-end encryption: All data is encrypted in transit (TLS 1.2+) and at rest using AES-256 or equivalent. Encryption keys are rotated regularly and managed via secure vault services.
- Infrastructure security: TLS-enforced access, segmented network design, and behavioral monitoring detect threats and enforce least-privilege access to core services and data stores.
Modularity and built-in adaptability
We design life sciences systems as modular platforms, where each functional capability (e.g., randomization, data capture, investigational product supply) is delivered as an independent service. These services are orchestrated through configurable workflows and rule engines.
Such architecture allows business users to tailor data forms, workflows, and rules to study or assay-specific needs without system-wide refactoring or IT team involvement. For example, mid-study protocol amendments or lab SOP updates affect only the relevant modules, which are versioned and revalidated independently.
The architecture also supports event-driven automation, where workflows are triggered by API calls or data changes from internal or partner systems. This way, automated workflows can be assembled dynamically for each trial, assay, or batch scenario. Modular templates and reusable components help roll out new trials or experiments faster, while maintaining full auditability and compliance traceability.
Interoperability with any internal and external systems and data sources
Our systems are built to interoperate with any digital asset in the life sciences ecosystem, from legacy on-premises databases, EHRs, and custom-built tools to CRO platforms and commercial SaaS solutions.
Structured data can be ingested via HL7 messages, FHIR resources, or REST APIs in alignment with USCDI data classes. Semi-structured data and flat files (CSV, XML, ASTM outputs) are transformed through configurable mapping layers. CCDA documents can also be exchanged where standardized clinical summaries are required. When APIs are unavailable, we establish secure file exchange pipelines or use hybrid connectivity (e.g., SFTP tunnels, cloud-to-on-premises bridges).
This flexibility allows organizations to avoid vendor lock-in, eliminate manual data re-entry across systems (e.g., LIMS to CTMS, ELN to SDMS), and consolidate fragmented workflows into an integrated environment without disrupting ongoing research or revalidating upstream tools.
Centralized data architecture with AI analytics support
We design a centralized data layer that aggregates operational, research, lab, and compliance data into a unified repository. Records are harmonized using standardized data models and controlled vocabularies (e.g., CDISC, SNOMED, LOINC) and aligned with interoperability frameworks such as USCDI and CCDA. This enables consistent querying across timeframes, projects, studies, and research programs.
This unified architecture eliminates redundant data flows, accelerates reporting, and ensures full traceability from insight to raw record. AI and analytics modules access structured data directly, with no additional ETL or preprocessing required. This enables scalable, real-time insights and supports reproducible research and model validation.
Handling Typical Challenges in Life Sciences Software Projects
Challenge #1. Fragmented ecosystem and data silos result in labor-intensive processes
Many research teams, CROs, and labs still run disconnected systems (LIMS, ELN, CTMS, SDMS, etc.) that don’t exchange data. This leads to manual re-entry of sample and subject IDs, inconsistent records across systems, and delays due to file reconciliation and import/export cycles.
Solution
Challenge #2. Frequent protocol and SOP changes slow research and raise costs
Protocol amendments, assay updates, and procedural shifts occur repeatedly in clinical and lab research. Each change often requires modifying data forms, validation rules, or workflows, typically involving IT teams and delaying execution by weeks.
Solution
Challenge #3. New molecular and analyzer data formats arrive faster than software support
With next-generation sequencing (NGS), high-content imaging, and single-cell analytics, new file format variations (of FASTQ, OME-TIFF, FCS, and vendor CSVs) emerge nearly monthly. Existing software often rejects these files or misinterprets their metadata. Researchers are forced to pause their projects until IT teams provide support, which often requires major system redesign and rewriting of molecular data parsers.
Solution
Challenge #4. Cloud migration required for modern data processing carries operational risks
Legacy on-premises software or data warehouses can’t elastically scale to handle terabytes of NGS reads or support AI-driven pattern analysis in research data. However, moving these systems to AWS, Azure, or GCP carries the risk of interrupting ongoing studies, breaking instrument and data source integrations, and breaching compliance safeguards during transition.