Custom Healthcare Software Development

// Arobs Transilvania Software

Healthcare software solutions - Life Sciences

Healthcare software solutions – Life Sciences

At AROBS, our Life Sciences and Healthcare Software Solutions division has built a strong expertise in custom healthcare software development over the past several years. We developed successful long-term collaborations with major pharmaceutical companies, mainly in the USA and Canada.

Shorter Way From Research To Approval

Our mission is to streamline the journey from research to approval. We develop medical and healthcare software solutions that simplify clinical trial management, from research to approval, before products reach the consumer.

Optimizing Clinical Trial Processes

The clinical trial market demands constant optimization. We deliver healthcare software solutions that improve research methodologies’ efficiency and effectiveness. By staying ahead of market needs, we completed multiple large-scale projects, contributing to advancements in the pharmaceutical industry.

The Diversity of Healthcare Software Solutions. From Complex Projects to Various Apps

Our primary focus has been on the pharmaceutical sector. With 25+ years of expertise, we also developed areas influencing the health industry directly or indirectly, including lifestyle and environmental variables. We developed solutions such as:

Fitness
apps

Patient
monitoring systems

Health insurance
management systems

Environmental applications, such as responsible forest management tools

Our experience also includes developing IoT systems for intelligent buildings and cybersecurity solutions. These are essential for creating or expanding smart hospitals and healthcare units. Learn more about our medical software development expertise here.

Who We Serve

Looking for experts in healthcare software solutions?

Clinical Trials Management Systems Capabilities

Site Selection

Clinical trial invitation management
Tracking sites' statuses
Site ranking based on scoring algorithms
Management and analysis of sites' viability
Management of sites' evaluation
Record historical site data
Multi-format reporting

Training Management System

Training process & user management
E-learning modules and training archives
Online training and e-signatures
Auto-generated certificates of completion
Provide training reports
Track externally completed training

Documents Management

Document revision and approval within one system
Document storage within one repository
Reduce the time and costs associated with paper documents
Visibility of completion statuses per site
Manage document completion to accelerate study start-up, conduct, and close out
Seamless migration into the electronic Trial Master File (eTMF)

Notifications Management

Predefined notification templates & processes
Automated distribution & tracking of notifications
Group sites based on regulatory rules to receive notifications (Global, Region, Country)
Site compliance maintenance reminders
Latest IB and SUSARs automated distribution to new sites
Automatically store notification documents on the Trial Master File
Easy process of cancelling the distribution

Electronic Documents Repository

Ensure completion, compliance, and access to clinical Trial Master Files throughout the study lifecycle
Integrated documents management
Reports and overview of statuses of document completion

Site
Selection

Clinical trial invitation management
Clinical trial invitation management
Site ranking based on scoring algorithms
Management and analysis of sites' viability
Management of sites' evaluation
Record historical site data
Multi-format reporting

Training Management System

Training process & user management
E-learning modules and training archives
Online training and e-signatures
Auto-generated certificates of completion
Provide training reports
Track externally completed training

Documents
Management

Document revision and approval within one system
Document storage within one repository
Reduce the time and costs associated with paper documents
Visibility of completion statuses per site
Manage document completion to accelerate study start-up, conduct, and close out
Seamless migration into the electronic Trial Master File (eTMF)

Notifications
Management

Predefined notification templates & processes
Automated distribution & tracking of notifications
Group sites based on regulatory rules to receive notifications (Global, Region, Country)
Site compliance maintenance reminders
Latest IB and SUSARs automated distribution to new sites
Latest IB and SUSARs automated distribution to new sites
Easy process of cancelling the distribution

Electronic Documents Repository

eTMF

Centralize all trial-related documents in a single electronic repository
Ensure compliance with regulatory standards
Manage document workflows for collection, storage, review, and approval across the trial lifecycle
Maintain full audit trails with version history, timestamps, and user actions
Enable secure, role-based access for global teams
Enhance collaboration by allowing simultaneous access and updates across distributed teams
Support audit & compliance processes

Looking for development teams experienced in Pharma and Healthcare software solutions?

// Empowering Healthcare Through Technology. The Path to Secure and Efficient Processes

Medical Technology Whitepaper V 2.0 2024

Medical institutions can optimize resource allocation, transform patient care practices, and significantly contribute to medical research. Clinical trial management systems are the heart of evolution because they enhance healthcare operations and facilitate medical research processes. Our medical software whitepaper explores the connection between technology and medicine to offer a comprehensive perspective on modern healthcare software solutions.

Our whitepaper elaborates on data management systems while offering a bigger picture of the healthcare landscape. Find out the most recent trends and how medical software and hardware create an interconnected and secured information network. Modern medical infrastructure enables researchers and clinicians to provide faster and more precise results not only in clinical trials but also when it comes to patient care.

With the AROBS Life Sciences team’s extensive experience in developing healthcare software solutions and software products that simplify the clinical trial management process, from initial research to final approval, we are committed to driving progress and innovation. Download our whitepaper to discover the synergy between technology and clinical trials and get inspired to shape the future of healthcare together!

Seamless Integration with Existing Healthcare Systems

We integrate custom healthcare solutions with existing IT ecosystems, including Electronic Health Records (EHRs), Health Information Exchanges (HIEs), and connected medical devices. We ensure well-functioning interoperability through secure APIs, middleware solutions, standardized data exchange protocols and more. Integration unifies workflows, reduces administrative burdens, and enhances outcomes through real-time access to accurate clinical data.

Compliance with Industry Interoperability Standards

Our development practices adhere to key healthcare interoperability quality standards. By aligning with these protocols, data exchange across diverse healthcare systems meets regulatory requirements and supports long-term interoperability.

Real-World Interoperability Success Stories

In our collaborations, we also have to integrate custom clinical trial management systems with existing platforms. In such cases, leveraging a scalable interface and a secure API gateway allows better syncing between trial records and patient health histories. Thus, both trial efficiency and decision-making are enhanced.

One of our successful Clinical Trial Management Systems is a customizable FDA-compliant software used by manufacturers of pharmaceutical products in order to manage large volumes of data generated during clinical trials. In short, its functionalities lead to the reduction of process time from the research point to the end-consumer by up to 75%.

Solve your healthcare tech challenges!

Secured Software Development for Clinical Trials

Prioritizing safety is paramount in our Clinical Trials projects. Our specialists follow a proactive approach, focusing on security measures at every stage of the development process – from planning and design to coding, testing, and deployment.

Our commitment to continuous improvement includes workshops on the latest security standards, ensuring our team is well-prepared to identify vulnerabilities and adhere to secure coding practices. By focusing on implementing security principles, we mitigate risks and align with industry guidelines, including OWASP, NIST and even special requirements such as HIPAA.

Why AROBS for Life Sciences

Industry Expertise

Working with large pharmaceutical corporations from the US has given us valuable market insight and expertise that concerns the entire health industry. Thus, we can offer efficient healthcare software solutions based on the highest quality standards of the Food and Drug Administration Compliance and the best technologies applied to this domain.

Save time

Healthcare software solutions can save a lot of time when it comes to processes that imply a large amount of data, like in the case of a CTMS. As a result, developing a healthcare software solution significantly reduces the time required for complex processes and leads to efficiency, faster results, and competitive advantages in the market.

Save money

Furthermore, working with experts in healthcare software development will create a product that will reduce the time frame for long and complex processes. This results in an immediate drop in costs by important percentages. Meanwhile, this favors new investments and opportunities in the industry for your project.

Cost and Timeline Considerations for Custom Healthcare Software

Key Cost Drivers in Healthcare Software Projects

Several factors influence the budget and timeline for a healthcare software solution:

Software complexity
System integration
Compliance requirements
Deployment model

Impact of Compliance and Security on Cost and Timeline

Security and compliance are integral to healthcare software development. Key considerations that impact cost and timeline include:

Regulatory audits & certification. Ensuring compliance with HIPAA, FDA, GDPR, etc., requires additional development and documentation efforts.
Security measures. Implementing data encryption, user access controls, and logging mechanisms adds to development time and cost.
Testing & documentation. Comprehensive testing and detailed documentation are necessary to meet regulatory standards.

These efforts can account for a significant part of total project resources, but they are essential for market readiness and patient trust.

Budget Optimization Strategies

To help our clients build efficiently, we recommend:

MVP-first development. Start with core features, then scale.
Modular architecture. Build reusable components for long-term flexibility.
Prioritized roadmap. Focus on high-impact functionalities first.
Agile methodology. Enables real-time course corrections and budget control.

Get a Personalized Cost Estimate

Looking for a tailored solution for your clinical trial project? We offer an advanced vision mapping to define your scope and provide an estimated budget and timeline. Based on your needs, our previous expertise and current trends, we create a clear roadmap to achieve the desired results. Prepare to discuss:

Intended use case
Compliance requirements
Required integration
User roles and features

Contact us to get started.

Cut clinical trials costs and speed up results!

Solve your healthcare tech challenges!

FAQs on Clinical Trials

Which software is used in clinical trials?

Clinical trials rely on systems like CTMS (Clinical Trial Management System), EDC (Electronic Data Capture), eTMF (electronic Trial Master File), and IRT (Interactive Response Technology). These platforms support site management, data collection, regulatory compliance, and trial logistics.

What is CRF software?

CRF (Case Report Form) software is part of EDC systems. It allows the electronic capture of clinical trial data directly from sites. It ensures accuracy, compliance, and real-time monitoring.

What is the difference between EDC and CTMS?

EDC manages clinical data collection from study sites, while CTMS oversees operational aspects like site tracking, investigator communications, and study timelines. EDC is data-centric; CTMS is trial operations–centric.

What is IRT software?

IRT (Interactive Response Technology) manages randomization and drug supply in clinical trials. It helps automate patient assignment, drug dispensation, and inventory tracking across global sites.

How much does clinical trial software cost?

Costs vary based on scope and customization, depending on integrations, compliance needs, and user volume.

Which clinical trial phase is most expensive?

Phase III trials are usually the most costly due to large patient populations, multi-site operations, and long durations.

How risky are Phase 1 clinical trials?

Phase I trials carry moderate risk as they're the first to test safety and dosage in humans. They involve small participant groups and are closely monitored to manage adverse effects.

What is the average cost per patient in clinical trials?

The cost per patient in clinical trials depends on several factors, including the trial phase, therapeutic area, study duration, and complexity of procedures. Later-phase trials, especially in areas like oncology or rare diseases, tend to have higher per-patient costs due to intensive monitoring, advanced diagnostics, and longer follow-up periods.