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Your study starts with a handshake
We’re not a traditional CRO. We listen to your objectives, and offer honest feedback and constructive solutions. We work in collaboration with your clinical team to develop a solid plan. A clear, common direction results in a more successful study start-up, and focused management of your clinical trial.
You have one chance to make a great impression
We work with you to source the right sites for your clinical trial, and help you to differentiate yourself from others vying for trial time and patients.
Our innovative model lets you run your trial globally
This strategic, collaborative approach means you don’t compromise on quality, or worry about undermining patients’ rights.
Reducing risk. Improving efficiency
Our Project Managers are in constant contact with you and your team. They coordinate cross-functional teams and vendors to ensure timely, quality study data, keeping your trial and your budget on track.
Online Trial Management
Get status updates on your trial Any time. Anywhere.
Our secure, web-based Clinical Trial Management System (CTMS) gives you instant access to real-time information on the status of your trial – from enrollment tracking and site information to monitoring regulatory documents and reports.
Stiris' site managers are passionate about improving the quality of life for all.
They guide you through the complexities of running a study.
They have fine-tuned site processes, ensuring patients are properly identified and included for trials.
Biostatistics and Data Management
COMPLETED OVER 200
Our statistics and data management team has successfully supported over 300 clinical trials, including early phase studies, large pivotal studies, and multiple late phase studies. Our clients recognize the strategic benefits of working with our customer-focused team, using market-leading technology.
Medical Affairs & Pharmacovigilance
We keep you safe
Our safety team has adopted the most recent FDA and EMA regulations and directives on Pharmacovigilance (PV). We provide a comprehensive range of Medical Affairs and PV services throughout the product life cycle.
Our medical monitors are highly qualified physicians who know industry methodology and regulations, and prioritize the accuracy of your data while ensuring patient safety.
The company you have come to rely on for your clinical trial management needs also provides auditing services in the way that Stiris is known for: with quality, collaboration, and while keeping you safe.
- Inspection Preparation (FDA, Health Canada)
- Mock Regulatory Inspections (FDA, Health Canada)
- Onsite GCP support
- GCP, GVP, GMP, and GLP Auditing and Compliance Consulting
- Sponsor facilities, investigative sites, central labs
- Review of internal processes and Standard Operating Procedures
- Review of compliance with clinical trial, GxP and local regulations
- Review of CVs and training documentation
- Review of physical facility
- GCP training
- Responding to audit findings
- Qualification and Due Diligence Audits
- Evaluating Quality Management Systems (QMS) and Standards
- QMS Gap Analysis
- SOP authoring and review
- Development of Quality Plans and Internal Audit Programs
- Assist in implementing quality compliance programs
When failure is not an option
If you find yourself in ‘rescue mode’, Stiris has the expertise to help you design and implement a strategy, and get your trials moving in the right direction.
Stiris has rescued more than 40 clinical trials since 2005. In 2012 alone, more than 62% of our work was rescue work.