SureClinical

SureClinical is a cloud-native eClinical software and services company serving life sciences organizations including biotechnology, pharmaceutical, medical device, and clinical research sectors. Founded by experts in clinical operations and enterprise software, the company develops a connected suite of applications and a collaboration platform designed to automate, streamline, and accelerate clinical trial and quality management processes. SureClinical is headquartered in Reno, North America, with a global presence across the Americas, Europe, and Asia-Pacific, and its platform currently supports over 600 clinical trials globally.

The company serves sponsors, contract research organizations (CROs), clinical research sites, and medical research organizations across clinical operations, R&D, and quality functions. Its stated mission is to empower clinical teams with solutions that automate, streamline, and accelerate the delivery of treatments to patients globally.

eClinical Applications

• SureClinical offers a connected suite of applications including an Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), Investigator Site File (ISF), and Quality Management System (QMS).
• The suite is designed to connect previously disconnected clinical teams and applications, centralizing clinical data and intelligence.
• Studies can be deployed on the same day, allowing organizations to get started quickly rather than waiting months for implementation.
• Applications are built on open standards to support clinical data sharing with any system.
• The platform is scalable to support thousands of users and flexible enough to allow configuration changes without programming.

SurePlatform

• SurePlatform provides the underlying infrastructure for the eClinical application suite, offering FDA 21 CFR Part 11 and EU Annex 11 compliant electronic signing and document storage.
• The platform is accessible on mobile, web, and desktop, enabling anytime, anywhere access through any connected web application.
• It is designed to eliminate manual tasks such as wet signing, scanning, uploading, classifying, and storing clinical documents and forms.
• The platform supports open standards for interoperability and is described as a certified cloud environment.

Clinical Intelligence, Analytics, and AI

• SureClinical offers a clinical intelligence layer branded as SureAI, which provides analytics and AI capabilities to answer clinical data questions on a continuous basis.
• Private AI solutions are available either hosted on premises or in SureClinical's cloud environment.
• The analytics and AI tools are intended to centralize clinical intelligence and increase team productivity.

Clinical Research Services

• SureClinical provides CRO services alongside its software products, covering project startup through to ongoing support.
• Application services include administration, integration, migration, and training on SureClinical products.
• Services are designed to help organizations get started quickly, particularly those transitioning away from legacy applications or CRO vendors.
• The services portfolio is described as covering management of projects, people, programs, and payments.

Platform Design Principles and Compliance

• The platform was designed from the outset to automate manual clinical processes, connect distributed teams, and support centralized data access.
• It is built on open standards to facilitate data sharing across systems and organizations.
• Compliance features include FDA 21 CFR Part 11 and EU Annex 11 electronic signature and storage capabilities.
• The system is designed to avoid vendor lock-in by connecting applications, data, and intelligence through an open, collaborative ecosystem.
• Availability across mobile, web, and desktop is a core design requirement, supporting global and remote clinical teams.

Customer Base and Market Focus

• SureClinical serves customers in BioPharma (sponsors, CROs, and clinical research sites across clinical operations, R&D, and quality) and in medical devices and treatments (similar organizational roles).
• The platform supports global teams and has been adopted across biotechnology, pharmaceutical, medical device, and clinical research organizations.
• Early growth was driven by word-of-mouth and CRO partnerships, with the customer base continuing to expand since the company's founding.

SureClinical positions itself as an alternative to legacy life sciences software, offering a connected, compliant, and configurable eClinical ecosystem that covers the full range of clinical trial management needs from document management and quality systems through to AI-driven analytics and CRO services.