Our clinical trial data lives across Excel files on 12 different sites. Can you build an eClinical system that captures and consolidates it correctly?

Yes. We build eClinical systems that replace multi-site spreadsheet-based data capture with a structured eDC platform, including protocol-enforced data entry, site-level access controls, query management, and audit-ready export for regulatory submission. Data that drives regulatory decisions should not live in Excel.

Can you build pharmaceutical software that meets 21 CFR Part 11 requirements?

We can build technical controls that support a client's 21 CFR Part 11 validation plan, including attributable audit trails, role-based access, record retention, and electronic-signature workflows. Those features do not make a system compliant by themselves. Your quality, regulatory, legal, and validation teams define the intended use, approve the requirements, test the configured system, and own formal sign-off.

We need to build an HCP training platform that can roll out field force training faster than 6 weeks. Is that something you build?

Yes. We built a pharmaceutical training platform that reduced field force onboarding from 6 weeks to 10 days for a pharma client. An HCP and field force training platform with structured learning paths, knowledge assessments, completion tracking, and compliance certification is a specific product we build for pharma companies.

How long does pharmaceutical software take to build, and what does it cost?

The schedule and cost depend on the intended use, integrations, data migration, required controls, validation evidence, and who owns each approval. A training workflow and a clinical trial system do not carry the same boundary. We put the agreed scope, assumptions, responsibilities, exclusions, timeline, and price in writing after those requirements are understood.

Can you build drug serialization and traceability tracking for regulatory compliance?

We can build or integrate serialization workflows that assign and track identifiers across manufacturing, packaging, and distribution. DSCSA, FMD, and other market requirements differ, so the scope starts with requirements approved by your regulatory and supply-chain specialists. The software then implements the agreed identifiers, events, partner exchanges, access controls, and evidence without claiming that technology alone establishes compliance.

Pharmaceutical Software Development Company

Clinical data sitting in spreadsheets across 12 sites. Regulatory submissions delayed because your systems can't produce the right audit trail. Field force training that takes 3 months to roll out.

We build clinical trial systems, regulatory document workflows, HCP training tools, and pharmacovigilance software around the controls, evidence, access rules, and review process your qualified teams define.

Clinical trial, drug tracking, and regulatory workflows mapped to your control and validation requirements
HCP training platforms that cut field force onboarding from months to weeks
We built a pharma training platform that reduced onboarding time from 6 weeks to 10 days
Experience building healthcare and life sciences technology

The problem

Sound familiar?

Your trial data is spread across Excel files on 12 different laptops?
Regulatory submissions take twice as long as they should because your systems weren't built for compliance?

Short answer

RaftLabs builds custom pharmaceutical software for clinical operations, drug traceability, regulatory document control, patient management, and HCP training. For regulated workflows, the scope maps required controls, evidence, system boundaries, and the qualified people who own validation and sign-off.

01 Diagnosis

Problems we solve in pharma

01
Problem
Clinical trial data collection still using paper case report forms requiring manual transcription
Solution
Field investigators complete paper CRFs at clinical sites, then data entry staff manually key them into a central database. Transcription errors introduce data quality issues that require source data verification to resolve, adding weeks to data cleaning before a regulatory submission can be prepared. That's time and money lost before you've even reached the filing stage. We build electronic data capture systems where investigators enter data directly into structured eCRF screens with validation rules, cutting the transcription step and the errors it creates.
02
Problem
Regulatory submission dossier assembly taking months of manual document collation
Solution
Regulatory affairs teams preparing an IND, NDA, or MAA dossier can spend weeks locating documents across shared drives, resolving versions, chasing approvals, and updating status spreadsheets. The software problem is not deciding whether a dossier is acceptable. It is keeping the CTD module, document owner, version, approval state, target market, and submission status visible in one controlled workflow.Start with the maintained regulatory information management, document management, and eCTD publishing products already available. Custom work is justified when the valuable gap is the workflow between those systems, an internal approval model they cannot support cleanly, or a focused interface around the client's existing validated tools.
03
Problem
Pharmacovigilance adverse event tracking managed in fragmented systems with no automated signal detection
Solution
Adverse event reports arrive through multiple channels: call centres, clinical sites, literature review, and spontaneous reports. They get entered into separate systems with no automated aggregation. Signal detection relies on periodic manual review of case counts rather than automated pattern analysis across the full case database. Missed signals mean missed obligations. We build pharmacovigilance platforms that consolidate adverse event intake, route cases through medical review workflows, and surface signals from aggregate data without manual case counting.
04
Problem
Quality management system running on disconnected paper-based processes that auditors flag each inspection
Solution
SOPs, training records, deviation reports, CAPA records, and change controls exist in separate filing systems: some paper, some shared drive, with no single view of quality system status. FDA or EMA inspectors arrive and the QA team spends days locating records and demonstrating compliance. That cost in preparation time is avoidable. We build electronic quality management systems where SOPs, training, deviations, CAPAs, and change controls are managed in one platform with audit-ready reports generated on demand.

02 What we ship

Our pharmaceutical software development services

Clinical trial management software
Clinical trial data 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 across 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.
- 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 and track-and-trace systems
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.
- 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
HCP training and field force enablement platforms
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 to 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.
- 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 document management
Regulatory submission packages for FDA, EMA, PMDA, and other agencies are large, structured, and market-specific. Documents use CTD modules, cross-references, metadata, and electronic submission standards that should remain under the control of regulatory specialists.
Shared drives make it hard to see which version is current, who approved it, which market it belongs to, and whether a dossier section is ready for the next review. We create or integrate controlled workflows that make those states visible while maintained regulatory publishing tools continue to own specialist compilation and validation where appropriate.
- CTD-structured document management with module and section tracking
- Version control with change tracking and electronic approval workflows
- Dossier status by document owner, approval state, target market, and submission
- Checks defined and approved by the regulatory team before a document changes state
- Integration with maintained eCTD publishing, validation, signature, and archive systems where required
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
Patient management and remote monitoring platforms
Clinical trials and disease management programs that require patient monitoring face a real data challenge: patients aren't at the clinic. Their vital signs, symptom reports, and medication adherence data must be captured remotely and fed into clinical records.
We've built remote patient monitoring platforms with medical-grade data handling, encrypted storage with HIPAA-grade access controls, and integration with clinical data systems. Patients use a mobile app. Clinicians see structured data in their dashboard.
- 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
- Data storage with HIPAA-grade access controls, encryption, and 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
Pharmacovigilance and safety data management
Adverse event reporting is a post-market obligation. 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. Each case routes through a structured medical review and regulatory submission workflow.
- 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

03 Buy, build, or wait

The pharma software question is really about what your qualified teams can validate and own, not what a vendor demo shows.

Buy or rent

Veeva, MasterControl, or an eCTD suite, for regulated workflows
When a maintained product covers the workflow and your teams can validate it as-is.
Wait, while the vendor roadmap covers the gap
When the missing feature is a configuration item, not a new system.

Build custom

When the valuable gap is between maintained systems
When no product covers the workflow between your existing validated tools.
When your approval model cannot be configured
When internal sign-off rules need a focused interface around existing tools.
When training or field workflows are the bottleneck
When rollouts take months and a purpose-built platform cuts them to weeks.

Bottom line

Stay on maintained products while they cover the regulated workflow. Build when the gap between systems, or an approval model no platform supports, is where the time and risk live.

04 How we work

How we work with pharma businesses

01
Discovery
We document the intended use, markets, policies, existing systems, data flows, manual process, and the controls your qualified teams require. Discovery produces a written scope with responsibilities, assumptions, acceptance evidence, and exclusions called out explicitly.
02
Architecture
Audit trails, electronic signatures, access controls, data integrity, retention, and recovery affect the architecture. We review those decisions with quality, regulatory, security, and system owners before development begins, then record who owns validation and final approval.
03
Build
Development proceeds in reviewable increments. Audit trails, electronic signatures, access controls, and other agreed controls are tested against approved scenarios as the workflow is created rather than added after the main screens are complete.
04
QA and integration
We test the agreed functions and integrations against approved requirements and available system endpoints. Where the client's validation plan requires it, we provide system documentation and test evidence that can support IQ/OQ/PQ work. Formal validation strategy, execution, and sign-off remain with the client's qualified team or appointed specialist.

Trusted by

05 Track record

And GxP-aware architecture: 21 CFR Part 11

Pharma businesses across markets served: US, EU, APAC

Software products shipped: 100+

Scope, controls, ownership, and acceptance criteria: Written

06 Case studies

Case studies

01
AI-Driven Remote Patient Monitoring App for Chronic Care Management
Reduction in clinical decision-making time
20%
Patients adopted in 12 weeks
150+

08 Why us

Why choose us?

01
We've seen your problem before
Across dozens of industries, we recognise your situation fast, then frame the fix around your margin and your operations, not a generic template.
02
We own the number, not the ticket
We measure success the way you do: hours saved, revenue earned, margin recovered. We stay through launch and growth, so the result is ours to own.
03
Serious businesses trust us
Vodafone, T-Mobile, Cisco, Energia, Aldi, Nike. Building since 2015. Serious businesses keep coming back because we stay accountable long after launch.

09 Questions

Common questions

: We can implement technical controls that support a client's Part 11 validation plan, such as attributable audit trails, electronic-signature workflows, access controls, retention, and data-integrity checks. We do not certify a system or claim that a feature list makes it compliant. Your qualified quality, regulatory, legal, and validation teams define the intended use, approve requirements, execute validation, and sign off.
: Yes. Our most direct reference is a pharmaceutical training platform we built for a global pharma company with a large field force. The platform delivered training content, tracked completions, and produced compliance certificates. We cut their field force onboarding time from 6 weeks to 10 days. We've also built patient monitoring systems with clinical-grade data handling and HIPAA-grade access controls.
: We can integrate with SAP, Oracle, Veeva, and most systems that offer an API. For legacy systems without a modern API, we've built integration layers using batch file exchange, database connectors, and middleware. The integration approach depends on what your existing system supports, and we scope that work as part of the discovery process.
: For systems handling patient data, we design with data minimisation, encryption at rest and in transit, role-based access controls, and full audit trails. We use compliant cloud hosting (AWS or Azure in appropriate regions) and make sure data residency requirements are met. We're not a legal or compliance firm and don't give compliance advice, but we've built systems that passed their clients' HIPAA and GDPR reviews. We document our architecture decisions so your compliance team can review them.
: The schedule depends on intended use, integrations, migration, security review, required controls, validation evidence, and access to the people who approve each decision. We define a first useful boundary, dependencies, milestones, and validation responsibilities before committing to a delivery plan.

Pharmaceutical software by product

Get a build-vs-buy plan for your team.

Tell us your regulatory obligations, clinical data workflows, and where the current process creates risk or manual work. We'll map the first useful boundary, responsibilities, and evidence before putting a scope, timeline, and price in writing.

Scope and cost agreed before work starts. No surprises. No obligation.
Working prototype within 3 weeks of kickoff.
Pay by milestone. You see progress before each invoice.
60-day post-launch warranty. Bug fixes, UI tweaks, and deployment support. No retainer.
All conversations are NDA-protected.

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