Frequently Asked Questions - Company and Solutions
Most frequent questions and answers
Company
Who is SterlingBio?
SterlingBio is a managed technology solutions provider focused on clinical trials, serving biopharma sponsors across the U.S. for over 20 years. As a woman-owned business, SterlingBio holds qualifications for federal research contracts. The company operates SureClinical, a private cloud-based clinical application suite developed with an AI knowledge graph to enable machine-learning-ready clinical information repositories. SureClinical has supported over 1,000 clinical trials since 2015, passing multiple FDA audits and meeting stringent regulatory standards, including FDA, EU, ISO-9001, HIPAA, SOC-1, SOC-2, and SOC-3. With advanced AI capabilities, SterlingBio offers innovative solutions to help biopharma organizations achieve a competitive edge.
CRO Services and Solutions
What Problems does SterlingBio Solve?
For biopharma Sponsors that are dissatisfied with disconnected apps, information islands, labor intensive processes, and missing metrics, SterlingBio offers clinical CRO solutions consisting of connected AI native clinical applications, AI Agents and analytics, all delivered on a centralized clinical intelligence repository in compliance validated private clouds.
For small and mid-size biopharma Sponsors who are on a limited budget, Clinical trial services and solutions often cost too much, harming innovative biopharma firms and raising drug costs. SterlingBio aims to change the CRO services landscape by offering affordable CRO services with free best in class eClinical apps.
What markets and customers does SterlingBio serve?
SterlingBio provides focused CRO clinical services and technology solutions to biopharma clinical research sponsors, clinical research organizations, clinical research facilities in business, academic and government settings.
What Solutions does SterlingBio Offer?
SterlingBio provides Managed Application Solutions and Services, specifically for clinical trials. We provide biopharma sponsors and CROs with best in class clinical application services, along with best in class pre-validated, FDA/EMA compliant clinical applications for ETMF, EISF, CTMS, EQMS as well as clinical private AI solutions and services. In the AI area, we provide private AI solutions and services that provide on-premise or private VPN based solutions for your organization. We can provide intelligent agents with advanced analytics and workflows that are based on your private, centralized clinical intelligence data. This connected, compliance-validated platform leverages private cloud technology to automate and streamline clinical processes, supporting faster and more efficient trial outcomes. With over 20 years of experience as a focused CRO, SterlingBio aims to democratize clinical services by making high-quality solutions accessible and affordable for all. Additionally, SterlingBio is a qualified woman-owned contractor for federally funded research projects.
What is SterlingBio’s value proposition?
For BioPharma sponsors who are dissatisfied with legacy solutions with information islands, labor-intensive processes, and missing metrics, SterlingBio offers clinical solutions consisting of connected AI native clinical applications, process automation, and a centralized clinical intelligence repository to combine disparate datasets. Our AI platform provides intelligent decision support with AI Agents, trend analysis, and flexible reporting in an FDA, EU and ISO-9001 compliance validated private AI cloud offering.
Are SterlingBio's SureClinical Applications free?
SterlingBio provides a freemium model to help biopharma sponsors reduce development time and costs for new treatments and devices, ultimately accelerating time-to-market. With our managed services plans, core team members can access our primary clinical applications and platform for free, avoiding the prohibitive costs of legacy software that can stifle innovation. Additional licenses, connectors, and AI services are available for a fee to scale up as needed. Starting in 2025, SterlingBio is also co-sponsoring a centralized Clinical AI Repository and Platform as an open-source initiative in partnership with a leading AI academic and medical institution, further enhancing access to advanced clinical intelligence tools.
What is SterlingBio’s Business Model?
SterlingBio provides a focused set of clinical trial services with a mission of reducing clinical trial timelines with higher quality. SterlingBio offers a freemium clinical application and clinical platform licensing model where a limited number of licenses are free for core clinical users. We provide fast and affordable solutions to support sponsors with rapid project startup, staffing and technology automation. Unlike other CROs who charge premium prices for CRO services and software, we have our own suite of proven and validated eClinical applications, which we provide at no cost to the core clinical study project team. Our certified and trained experts offer managed clinical application IT and data entry services, project management services, and AI cloud services and management, for a fee to support clinical trials. Because customers don’t pay for the core applications, CRO service costs will typically be the lowest of any CRO offering. For customers who wish to purchase additional application licenses, AI datasets or platform connectors and technology solutions, SterlingBio generates additional licensing revenues.
What CRO services and solutions SterlingBio offer?
SterlingBio’s focused clinical CRO solutions include:
-Comprehensive CRO clinical services
-AI-native clinical applications
-AI agents with advanced analytics
-Centralized Clinical AI Repository Platform
-Compliance-validated private AI cloud