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?

Yes. 21 CFR Part 11 compliance is built into the architecture from the first sprint. That includes audit trails capturing every data creation, modification, and deletion event with user identity and timestamp; electronic signatures that meet the Part 11 definition; role-based access controls; and the validation documentation (IQ, OQ, PQ) that an FDA inspection expects. Compliance is a first-class design requirement.

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?

Most pharmaceutical software projects deliver in 12 to 16 weeks. The timeline reflects the validation documentation requirements and the compliance architecture. Cost depends on scope: a training platform is a different scope from a full clinical trial management system. Fixed cost is agreed before development starts, with validation documentation included as part of the project.

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

Yes. We build serialization platforms that assign and track unique identifiers per serialized unit through manufacturing, packaging, and distribution. These meet DSCSA (US), FMD (EU), and other track-and-trace regulatory requirements. The serialization architecture is scoped to the specific regulatory requirements applicable to your markets.

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 management systems, regulatory document platforms, HCP training tools, and pharmacovigilance systems with 21 CFR Part 11 compliance and GDPR designed in from the first sprint, not added when the regulatory review finds gaps.

Clinical trial management, drug tracking, and regulatory compliance systems built with 21 CFR Part 11 and GDPR in mind
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
100+ products shipped including healthcare and life sciences technology

What you can count on

Retention

3+ years

Average client relationship across active accounts

First milestone

Week 3

Working prototype in front of real users

Pricing

Fixed price

Scope and cost agreed before work starts

Team

No handoffs

The senior engineers who scope the build also ship it

4.9

on Clutch

See our work

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 pharma companies replacing manual, error-prone processes. Clinical trial management systems, drug serialization platforms, regulatory compliance tools (21 CFR Part 11 and GDPR), patient management portals, and HCP training platforms. Most builds are production-ready in 12-16 weeks with audit trails and compliance documentation built in from sprint one.

Trusted by

And GxP-aware architecture: 21 CFR Part 11

Pharma businesses across markets served: US, EU, APAC

Software products shipped: 100+

Cost delivery: Fixed

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 spend months locating documents across shared drives, version-controlling them manually, and assembling them into CTD format. Submission timelines slip because document readiness is tracked in spreadsheets with no automated status visibility. Every day of delay is a day further from approval. According to the European Medicines Agency's internal data (as reported by Citeline's Pink Sheet, 2023), only 30-40% of Marketing Authorisation Applications submitted to the EMA between 2018 and 2022 arrived on time, with 42% of applicants requesting extensions due to insufficient data maturity. We build document management systems structured around the CTD module hierarchy, with version control, approval workflows, and submission package assembly built into the platform.
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.

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 enormous, structured, and must 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 problems and delays submissions. We build document management systems for regulatory affairs teams that enforce structure, track versions, and produce submission-ready packages.
- 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
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, HIPAA-compliant storage, 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
- 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
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

How we work with pharma businesses

01
Discovery
We document the regulatory framework your system needs to operate in: 21 CFR Part 11, GxP, GDPR, HIPAA. We identify the specific compliance requirements that affect the build, map your existing systems, data flows, and the manual process we're replacing. Discovery produces a documented scope with compliance requirements called out explicitly, not a generic proposal.
02
Architecture
Pharma software must be correct and must prove it was correct. Audit trail design, electronic signature implementation, and data integrity controls are architectural decisions that are harder to retrofit than to build correctly from the start. We walk your quality and regulatory affairs team through the architecture before development begins.
03
Build
Development runs in two-week sprints. Compliance-critical features: audit trails, electronic signatures, access controls, are built and verified in each sprint rather than assembled at the end. You can review working software in a staging environment from week four, with test scenarios covering the compliance-critical workflows.
04
QA and integration
We run functional testing against the protocol and regulatory requirements defined in discovery. Integration testing with ERP, EDC, or clinical systems runs against your actual system endpoints. If your quality team requires IQ/OQ/PQ documentation, we provide the system documentation and test evidence that supports the validation process. Formal validation sign-off is completed by your qualified team.

Frequently asked questions

: Yes. For systems that require FDA compliance under 21 CFR Part 11, we design with the specific technical controls the regulation requires: audit trails with timestamps and user identification, electronic signature implementation with identity binding, system access controls, and data integrity validation. We can also support the validation documentation (IQ/OQ/PQ) that GxP-regulated clients need. We're not a validation consultancy, you'll need a qualified validation team to sign off, but we build systems that are designed to pass.
: 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-compliant architecture.
: 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.
: A focused build, like an HCP training platform or an adverse event intake system, typically takes 12 to 16 weeks from kickoff to go-live. Clinical trial management systems are more complex, typically 4 to 6 months for a full build. Systems that require validation documentation take longer because the documentation process runs alongside development. We agree on milestones at the start so you know what to expect at each stage.

Pharmaceutical software by product

01
Clinical trial management software development
02
Drug serialization and track-and-trace software
03
HCP training platform development for pharma
04
Regulatory document management software for pharma
05
Remote patient monitoring software for pharma
06
Pharmacovigilance software development

What clients say

What our life sciences clients say

Three-year average engagement. Founders and operators describing the work in their own words. No marketing varnish.

Dr. Smith

USA

Primary Care Physician

PDC has been a great addition to our clinic. It helps us stay connected with patients and makes clinical decision-making significantly faster.

01 / 02

Proof

Case studies

AI-Driven Remote Patient Monitoring App for Chronic Care Management

20%: Reduction in clinical decision-making time
150+: Patients adopted in 12 weeks
100%: HIPAA compliance

Read case study

Related services

Talk to us about your pharmaceutical software project.

Tell us your regulatory obligations, your clinical data workflows, and where your current systems create compliance risk or operational overhead. We'll scope the right platform and give you a fixed cost.

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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