Pharmaceutical Software Development Company

Clinical trial data is high-stakes data. It drives regulatory submissions. It affects drug approval timelines. It has to be accurate, auditable, and accessible across multiple sites and time zones.

Most mid-size pharma companies run their trials in a mix of Excel, email, and paper case report forms. That works until it doesn't -- and it stops working at the moment you need to file. We build eClinical systems that capture trial data at the source, enforce protocol compliance, and produce audit-ready outputs.

What you get

• Electronic data capture (EDC) designed around your protocol
• eCRF (electronic case report form) builder with validation rules
• Site management with investigator and patient tracking
• Adverse event logging with automated regulatory reporting triggers
• Full audit trail with electronic signature support (21 CFR Part 11)
• Data export in CDISC SDTM format for regulatory submission

Best for

• Pharma companies running trials where data is collected manually across sites
• CROs managing multiple studies and needing a platform that handles both
• Biotech startups preparing for IND or NDA submission and needing audit-ready data

Drug serialization is no longer optional in most markets. DSCSA (US), FMD (EU), and similar regulations require unique identifiers on each saleable unit, and the ability to trace any product from manufacturer to patient.

We build serialization systems and track-and-trace platforms that generate, apply, and report unique identifiers across your supply chain. These connect to your existing ERP or manufacturing execution system and produce the EPCIS reports your trading partners and regulators require.

What you get

• Unique identifier generation and aggregation (item, case, pallet)
• Integration with packaging line equipment (printers, cameras, rejection systems)
• EPCIS event reporting for DSCSA and FMD compliance
• Wholesaler and distributor portal for product verification
• Suspicious product alert management and investigation workflows
• Integration with SAP, Oracle, and industry-specific manufacturing systems

Best for

• Pharmaceutical manufacturers building or upgrading serialization capability for DSCSA or FMD compliance
• Generic drug manufacturers handling high-volume serialization on multiple production lines
• CMOs managing serialization on behalf of multiple pharma clients

Medical representatives need to learn complex clinical data, product positioning, and compliance rules before they talk to a single doctor. Traditional training -- classroom sessions, printed manuals, in-person sign-offs -- takes 6--10 weeks and doesn't scale.

We built a pharmaceutical training platform for a global pharma company that cut field force onboarding from 6 weeks to 10 days. The platform delivers digital modules, competency assessments, and certification tracking -- with a full audit trail for regulatory sign-off.

What you get

• Mobile-first training modules with video, interactive content, and knowledge checks
• Compliance training with e-signature confirmation and completion certificates
• Role-based content delivery -- reps see modules relevant to their territory and product line
• Manager dashboards for tracking team completion and assessment scores
• Integration with HR systems for user management and onboarding automation

Best for

• Pharma companies with large field forces and slow, manual training processes
• Medical device companies with complex product portfolios and training requirements
• CROs and research organisations needing protocol training at scale

Regulatory submission packages for FDA, EMA, PMDA, and other agencies are enormous, structured, and need to be correct. Documents get submitted in CTD format, with cross-references, metadata, and electronic submission requirements that differ by region.

Manual document management in shared drives creates version control nightmares and delays submissions. We build document management systems for regulatory affairs teams that enforce structure, track versions, and produce submission-ready packages.

What you get

• CTD-structured document management with module and section tracking
• Version control with change tracking and electronic approval workflows
• Automatic formatting checks against agency-specific submission templates
• eCTD compilation and validation tools for electronic submissions
• Integration with electronic signatures and audit trail requirements

Best for

• Pharma regulatory affairs teams managing multiple submissions across multiple markets
• Biotech companies preparing first IND, NDA, or MAA filings
• Companies managing post-approval CMC changes and annual reports across regions

Clinical trials and disease management programs that require patient monitoring face a data collection challenge: patients aren't at the clinic. Their data -- vital signs, symptom reports, medication adherence -- has to be captured remotely and fed into clinical records.

We've built remote patient monitoring platforms with medical-grade data handling, HIPAA-compliant storage, and integration with clinical data systems. Patients use a mobile app. Clinicians see structured data in their dashboard.

What you get

• Patient-facing mobile app for remote data entry and device sync
• Medical device integration (Bluetooth vital sign monitors, CGMs, wearables)
• Structured data capture mapped to clinical terminology (SNOMED, LOINC)
• Clinician dashboard with alert rules and patient-level data review
• HIPAA-compliant data storage with full audit trail
• Integration with EDC systems and electronic health records

Best for

• Clinical trials running decentralised or hybrid site models
• Pharmaceutical companies running patient support programs with remote monitoring components
• Digital therapeutics companies building an evidence base for FDA clearance

Adverse event reporting is a post-market obligation, not a nice-to-have. Missing a report, submitting late, or producing an inaccurate CIOMS or MedWatch form can result in regulatory action.

We build pharmacovigilance tools that capture adverse events from multiple sources -- call centres, clinical sites, literature, and spontaneous reports -- and route them through a structured medical review and regulatory submission workflow.

What you get

• Multi-channel adverse event intake: web form, email-to-case, call centre integration
• Medical review workflow with causality assessment and seriousness criteria
• Automated regulatory submission file generation (CIOMS, MedWatch, E2B)
• Signal detection and aggregate reporting tools
• Integration with EudraVigilance, FDA FAERS, and regional safety databases

Best for

• Pharma companies scaling their pharmacovigilance operations beyond spreadsheet management
• Biotech companies preparing for their first drug approval and post-market requirements
• CROs providing pharmacovigilance services to multiple pharma clients