Clinical trial management software development

When even minor bottlenecks or errors can delay life-saving therapies, we help you build software that simplifies and centralizes your trial operations, freeing your team from paperwork and disparate systems.

15+

pharma AI/ML consultants

50+

engineers specializing in pharma, biotech and CRO

40+

AI-driven drug R&D projects delivered

15+

pharma AI/ML consultants

50+

engineers specializing in pharma, biotech and CRO

40+

AI-driven drug R&D projects delivered

Our clinical trial software development services

Partner with a technology partner to cover every aspect needed to plan, build, and support a robust CTMS tailored to your needs. Each service we offer translates directly into time and cost savings or quality improvements for your clinical teams.

Technologieberatung

Assessing your current clinical IT ecosystem and designing a modernization roadmap aligned with GxP best practices and your business goals.

Custom CTMS development

Developing centralized GCP-compliant clinical trial management software tailored to your protocols and workflows, built only around features that add value.

Systems integration

Integrating your CTMS with existing software, such as EDC, LIMS, eTMF, and EHR/EMR, to break down silos and enable automated data flows between systems, improving data accuracy and giving your team a 360-degree view of every trial.

Compliance Support

Building features like audit trails, e-signatures, role-based access control, and automated report generation to ensure adherence to FDA 21 CFR Part 11, ICH GCP, HIPAA, GDPR and other relevant standards.

Datenmanagement und -analyse

Designing clinical data management solutions that not only capture trial data but also turn it into actionable insights through integrated BI tools and analytics dashboards.

How we leverage AI/ML for smarter clinical trials

We implement artificial intelligence and machine learning to power clinical trial management in multiple areas, where tremendous opportunities go hand in hand with unpredictable challenges.

Patient recruitment and retention

Target ideal participants and tailor engagement strategies by deploying AI algorithms that help identify eligible patients from medical records and predict which enrollees might drop out.

Prädiktive und präskriptive Analyse

Proactively adjust protocols and resource allocation to prevent failures by using AI tools to forecast enrollment rates, likely responders vs non-responders, and potential safety events while spotting hidden patterns in historical trial data.

Risk-based monitoring

Focus monitoring efforts where they matter most with the help of ML-driven algorithms that flag high-risk sites, data anomalies, or protocol deviations in real time.

Site and investigator selection

Analyze historical performance metrics, recruitment success, patient population data, and more to rank sites and investigators by suitability.

Operational process automation

Reduce human error and free up your researchers for higher-value work by implementing AI that automates repetitive trial operations, including auto-scheduling patient visits, NLP-powered data entry, and chatbot assistants.

Challenges we solve with custom CTMSs

Unlike one-size-fits-all software, which often leaves critical pain points unresolved, our CTMS solutions are purpose-built to eliminate the most notorious obstacles in clinical research aligned with the specifics of your organization.

Fragmented data and lack of centralization

Slow, costly patient recruitment

Non-compliance with security and regulations

Inefficient site management and collaboration

Operational bottlenecks

Budget overruns and payment delays

Poor patient engagement and retention

Limited visibility and reporting

Fragmented data and lack of centralization

Implement a unified platform that consolidates all study data in one place, in real time, improving consistency and accessibility.

Slow, costly patient recruitment

Tap into data-driven patient recruitment tools that prescreen EHR data, automate outreach and identify ideal sites to find patients faster.

Non-compliance with security and regulations

Ensure compliance is baked into your software and every action is tracked and auditable so you can confidently meet FDA, EMA, IRB, and other industry requirements.

Inefficient site management and collaboration

Improve site management by standardizing site workflows through features like investigator portals, task dashboards, and instant document exchange.

Operational bottlenecks

Automate workflows and integrate systems that allow for swift handling of routine tasks and seamless exchange of information between stakeholders.

Budget overruns and payment delays

Make the most of built-in budget management and payment automation so you can plan and monitor budgets in real time as well as automate site payments based on milestones such as patient visits and data submissions.

Poor patient engagement and retention

Take advantage of patient-centric features like eConsent, mobile patient apps, visit reminders, and feedback surveys so patients can conveniently report symptoms and view their lab results through secure portals, increasing their engagement, keeping them informed and improving the overall trial experience.

Limited visibility and reporting

Use real-time dashboards and custom reports on all critical KPIs to gain full visibility into trial progress and data quality, delivered to your stakeholders on the fly.

Fragmented data and lack of centralization

Implement a unified platform that consolidates all study data in one place, in real time, improving consistency and accessibility.

Slow, costly patient recruitment

Tap into data-driven patient recruitment tools that prescreen EHR data, automate outreach and identify ideal sites to find patients faster.

Non-compliance with security and regulations

Ensure compliance is baked into your software and every action is tracked and auditable so you can confidently meet FDA, EMA, IRB, and other industry requirements.

Inefficient site management and collaboration

Improve site management by standardizing site workflows through features like investigator portals, task dashboards, and instant document exchange.

Operational bottlenecks

Automate workflows and integrate systems that allow for swift handling of routine tasks and seamless exchange of information between stakeholders.

Budget overruns and payment delays

Poor patient engagement and retention

Limited visibility and reporting

Use real-time dashboards and custom reports on all critical KPIs to gain full visibility into trial progress and data quality, delivered to your stakeholders on the fly.

Benefits of our custom clinical trial software

Implementing a tailor-made CTMS with Innowise yields tangible benefits across all of your operations.

01/04

Höhere Produktivität

Automating manual tasks and digitizing workflows means your team spends less time on paperwork and chasing data, and more on critical analysis.

02/04

Datenbasierte Entscheidungen

With a centralized database and real-time analytics, decisions are based on evidence, not guesswork.

03/04

Enhanced transparency

Sponsors, CROs, and investigators all operate on the same platform, seeing up-to-date information and status reports, which builds trust and collaboration among stakeholders.

04/04

Verbesserte Compliance

Our systems are designed to enforce compliance with regulatory and quality standards automatically.

Höhere Produktivität

Datenbasierte Entscheidungen

Enhanced transparency

Verbesserte Compliance

Mit Experten sprechen

Ready to bring these advantages to your clinical tries? Get started today by speaking with our pharma technology experts and exploring a tailored implementation plan.

Innowise’s trial clinical software development process

We follow a comprehensive, step-by-step process to ensure your CTMS is in line with your needs and meets the highest industry standards.

Anforderungsanalyse

Analyzing your protocols, workflows, roles, and constraints with our domain experts to capture complete functional and regulatory requirements. You start with a clear, validated scope that fits your operational reality and eliminates rework.

System blueprinting

Mapping out the system architecture, data models, modules, integrations, and compliance controls. We align everyone on how the final CTMS will work with visual prototypes and specifications that de‑risk delivery.

Prototype and UX design

Prototyping key flows and designing intuitive role‑based interfaces for investigators, monitors, data managers, and admins. This results in faster adoption and fewer user errors, because the product matches how your teams actually work.

Agile Entwicklung

Implementing features in iterative sprints and on a scalable tech stack, and configuring required third‑party APIs. You see working software early, while we incorporate feedback continuously and keep timelines on track.

Testen und Qualitätssicherung

Testing functionality, performance, and security while validating against 21 CFR Part 11 and GCP with documented IQ/OQ/PQ. This means fewer production issues and audit‑ready evidence that your system is compliant.

Bereitstellung und Integration

Deploying securely to cloud or on‑prem, integrating with EHR, LIMS, eTMF, EDC, and identity systems, and migrating live study data safely. We ensure a smooth go‑live with minimal downtime and unified data flows across your ecosystem.

User training and documentation

Training each user group and delivering clear SOPs, admin guides, and quick‑reference materials. Your team becomes self‑sufficient from day one and support tickets stay low.

Ongoing support and evolution

Monitoring and enhancing the CTMS by scaling infrastructure and adding features. Your platform keeps pace with your pipeline and compliance changes without disruption.

Keepin patient data safe and trials audit-ready

Understanding that clinical trial data is highly sensitive, Innowise implements robust security measures and compliance practices to protect your information and maintain trust.

End-to-End-Verschlüsselung

Implementing AES-256 encryption for stored data and TLS/SSL for transfers to keep patient and trial information fully protected. Even if a breach occurs, data remains unreadable and secure from exposure.

Access control and audit trails

Enforcing granular permissions, multifactor authentication, and detailed audit logs to track every user action. You gain complete oversight and can demonstrate accountability during any inspection or audit.

Regulatory compliance built-in

Designing CTMS platforms that inherently meet ICH GCP, 21 CFR Part 11, HIPAA, and GDPR standards. Your teams spend less time worrying about compliance and more time advancing research.

Secure infrastructure and processes

Hosting solutions on ISO 27001- and ISO 13485-certified clouds with continuous updates, penetration testing, and OWASP-based coding practices. We keep your data and systems resilient, reducing cybersecurity risks and downtime.

Wir arbeiten mit

We collaborate with a broad range of organizations in the pharmaceutical and healthcare research space, with solutions customized to the unique workflows of each client type.

Pharmaunternehmen

Biotechnology firms

CROs

Academic research institutions

Hospitals conducting clinical studies

Ready to transform your clinical trials?

Empower your team with a secure, data-driven platform that accelerates research and simplifies compliance. Contact us today to discuss your needs or request a demo. Let’s bring better treatments to patients faster.

Success stories of our pharma clients

We are proud of the measurable success our clients have achieved using Innowise’s solutions. Here are a few examples that demonstrate our impact in the clinical and pharmaceutical domain:

Why choose Innowise for clinical trial software

See what makes Innowise the trusted choice for healthcare innovators:

Umfassende Branchenkenntnisse

Drawing on 18+ years of software development and a specialized healthcare team, we understand the nuances of GCP, data standards, and clinical workflows. You get a partner who speaks your language and anticipates your challenges.

Proven delivery record

Having delivered dozens of healthcare and life science projects worldwide, we are trusted by companies such as Novartis and CVS Health. Our clients consistently report tangible outcomes: shorter timelines, lower costs, and seamless compliance.

End-to-end capabilities

Covering the entire lifecycle from consulting to support, Innowise ensures unified delivery and accountability. You won’t need multiple vendors to manage integration, validation, or AI enablement; we handle it all.

Certified quality and security

Our ISO 13485 and ISO 27001 certifications guarantee robust quality management and information security practices. Every deliverable meets stringent regulatory expectations and passes validation.

Focus on innovation

Leveraging AI, MLOps, and advanced analytics, we future-proof your CTMS to adapt to evolving data and regulatory demands. You benefit from scalable, forward-thinking solutions that continue to deliver value over time.

Was unsere Kunden denken

Marco Scarpa Technischer Produktmanager Beantech S.r.l

“Es war eine sehr intensive und effektive Zusammenarbeit, alle Entwickler waren auf die Ziele fokussiert und auf alle Technologien vorbereitet, mit denen wir uns auseinandersetzten.”

Branche IT-Services
Teamgröße 6 Spezialisten
Dauer 22+ Monate
Leistungen IoT Entwicklung

Nikolay Orlov CEO KEYtec AG

“Was mich an Innowise am meisten beeindruckt hat, war ihre Fähigkeit, sich an unsere spezifischen Bedürfnisse anzupassen und gleichzeitig strenge Zeitvorgaben einzuhalten. Sie kombinierten einen kundenorientierten Ansatz mit starken Projektmanagement-Fähigkeiten und stellten sicher, dass die Ergebnisse hochqualitativ und pünktlich geliefert wurden.”

Branche Finanzservices
Teamgröße 2 Spezialisten
Dauer 8 Monate
Leistungen IT Managed Services

Gian Luca De Bonis CEO & CTO Enable Development OÜ

“Wir sind beeindruckt von ihrer Flexibilität und ihrer Bereitschaft, Lösungen für herausfordernde Situationen zu finden. Sie haben in jeder Situation aktiv geholfen. Die Bereitschaft des Teams, optimale Ergebnisse zu liefern, sichert den Erfolg der Partnerschaft.”

Branche IT-Beratung
Teamgröße 8 Spezialisten
Dauer 36 Monate
Leistungen Staff Augmentation

FAQ

A CTMS is a centralized system that manages essential aspects of clinical trials — from planning to tracking and reporting. It brings together data, workflows, and documentation across study sites to enhance operational efficiency and strengthen collaboration among sponsors, CROs, and investigators.

Modern CTMS platforms include modules for study setup, site and investigator management, subject tracking, financial management, and regulatory document handling. They also integrate with systems such as EDC, LIMS, or EHR to provide unified and validated data flows.

A custom CTMS fits your organization’s specific workflows, integrates seamlessly with existing infrastructure, and evolves as your pipeline grows. It provides long-term cost efficiency and competitive differentiation that generic solutions can’t match.

All solutions are designed according to ICH GCP, 21 CFR Part 11, HIPAA, and GDPR requirements. We provide full validation documentation (IQ/OQ/PQ) and support audits to prove system integrity and data protection.

Depending on complexity, timelines range from 4-6 months for a minimal version to 9-12 months for enterprise-grade systems with integrations and AI modules. Agile delivery ensures you see usable results early in the process.

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Sobald wir Ihre Anfrage erhalten und geprüft haben, melden wir uns bei Ihnen, klären erste Fragen und unterzeichnen bei Bedarf ein NDA, um die Vertraulichkeit zu gewährleisten.

Nach der Analyse Ihrer Ziele, Anforderungen und Erwartungen erstellt unser Team einen Projektvorschlag mit Leistungsumfang, Teamgröße sowie Zeit- und Kostenschätzung.

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Abschließend unterzeichnen wir den Vertrag und starten umgehend mit der Umsetzung Ihres Projekts.

Clinical trial management software development

Our clinical trial software development services

Technologieberatung

Custom CTMS development

Systems integration

Compliance Support

Datenmanagement und -analyse

How we leverage AI/ML for smarter clinical trials

Challenges we solve with custom CTMSs

Fragmented data and lack of centralization

Slow, costly patient recruitment

Non-compliance with security and regulations

Inefficient site management and collaboration

Operational bottlenecks

Budget overruns and payment delays

Poor patient engagement and retention

Limited visibility and reporting

Benefits of our custom clinical trial software

Innowise’s trial clinical software development process

Keepin patient data safe and trials audit-ready

End-to-End-Verschlüsselung

Access control and audit trails

Regulatory compliance built-in

Secure infrastructure and processes

Wir arbeiten mit

Success stories of our pharma clients

Why choose Innowise for clinical trial software

Umfassende Branchenkenntnisse

Proven delivery record

End-to-end capabilities

Certified quality and security

Focus on innovation

Was unsere Kunden denken

FAQ

Kontakt aufnehmen

Wie geht es weiter?

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