Need help with Clinical Trial Software Development?
Whether you're developing a new digital health product or extending an existing solution with Clinical Trial Software Development, 6B brings the technical expertise, healthcare insight, and experience needed to accelerate delivery.
From study startup and site management to data capture, monitoring, and eTMF compliance, our software solutions help streamline operations, reduce risk, and deliver faster, safer trials. Whether you’re running a single-centre study or managing multi-region Phase III trials, we deliver custom platforms built for precision, scalability, and regulatory alignment.
Understanding Clinical Trial Software
Clinical trial software plays a pivotal role in planning, executing, and monitoring clinical research activities. These platforms enable better coordination across sponsors, investigators, sites, and regulators — supporting faster enrolment, real-time data visibility, and greater protocol adherence.
Key types of clinical trial software include:
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture (EDC) platforms
- eConsent and ePRO solutions
- Electronic Trial Master File (eTMF) systems
- Site and investigator portals
- Safety and pharmacovigilance modules
- Randomisation and trial supply management
Each solution must meet strict requirements for data integrity, auditability, and global compliance standards — including FDA 21 CFR Part 11, ICH-GCP, GDPR, and ISO 14155. At 6B, we build clinical trial software with these standards in mind from the start, ensuring your platform is ready for regulatory scrutiny and global deployment.
Our Clinical Trial Software Development Process
As a Clinical Trial Software Development company, we use a structured, collaborative process to deliver powerful, compliant tools for clinical operations and data management.
We start by working with your clinical, regulatory, and operational teams to map your trial workflows and compliance needs. From protocol-specific data models to user roles and site management tools, we define every element of the system architecture in alignment with your trial design and study objectives.
Our development process combines agile methodology with formal quality management practices, including system validation, audit logging, and security governance. We support integration with lab systems, EDC tools, eTMF repositories, and external registries using industry-standard APIs and data formats such as CDISC, HL7, and FHIR.
Once deployed, we assist with user onboarding, documentation, and regulatory submission support — ensuring that your platform delivers both immediate and long-term value.
Benefits of Custom Clinical Trial Software
Tailored clinical trial software gives your organisation greater control, flexibility, and confidence throughout the research process.
Sponsors and CROs gain a single source of truth across multiple study sites, with real-time insights into enrolment, data quality, protocol deviations, and site performance. Site staff benefit from simplified workflows, automated reminders, and user-friendly interfaces that reduce administrative burden and improve compliance.
Regulatory and QA teams can rely on validated systems with complete audit trails, version control, and permissioned access — helping accelerate submissions and meet inspection requirements.
With 6B-developed software, you gain a clinical trial platform that aligns with your study design, scales with your pipeline, and ensures the highest levels of data integrity and compliance.
