Services & Solutions

Even with the most careful planning, sometimes projects don’t work out as expected. Many reasons can contribute to jeopardizing a trial: recruitment lags behind, monitoring is delinquent, data quality is questionable, site relationships are damaged, providers’ resources aren’t adequate to fulfill obligations, etc.

When you find yourself in ‘rescue’ mode, you need a partner who understands all the delicacies involved with getting a project back on track. Stiris has been recruited to manage the rescue of over 50 trials. Our team has the knowledge and expertise to work with you to design and implement a rescue strategy, rebuild and strengthen site relationships, and get trials moving in the right direction. That doesn’t happen by chance, it happens with purpose, accountability and teamwork.

A client brought up the Three Musketeers reference ‘All for one and one for all’. While we joke about it – it really is what you get. There are times when speed is critical, like when a third of your sites won’t get a close out visit because your “preferred CRO” doesn’t have personnel available. We understand the stress placed on you by management, which is why we mobilize the way we do to make it happen.

Stiris Project Managers are all strong leaders, who have developed their skills over many years in clinical research as CRCs, CRAs and Project Managers. Over 40% of our team has held executive positions in Pharmaceutical, Biotech and CRO companies. As part of your team our Project Managers:

Clinical Monitors are the front line of clinical research. At Stiris, our team of CRAs doesn’t just monitor your study, they manage the sites.  The CRAs are pivotal in determining a study’s success (as measured by recruitment, data quality and issue management). The Stiris team of knowledgeable CRAs will ensure the sites are supported and motivated to provide the cleanest data possible in the shortest time possible.

All CRAs are trained to our extensive SOPs to ensure quality and consistency of services such as:

• Site identification/feasibility
• Site qualification visits
• Site activation
• Site Initiation Visits
• Informed Consent review and process review
• Review of site SOPs, policies and procedures documentation
• Ongoing monitoring of site/study recruitment, eligibility, source document verification
• Site Study Coordinator mentoring services available
• Data collection (electronic or paper)
• Query resolution
• Safety reporting (Adverse Event and Serious Adverse Event reporting procedures)
• IP review, accountability and return/destruction
• Investigator Site File review and reconciliation
• Site audit preparation assistance
• Site Close-out Visits

Stiris’ safety team provides a comprehensive range of Medical Affairs and Pharmacovigilance services throughout the product life cycle. The Medical Monitor is an integral partner throughout the trial, collaborating across functional units to assist you in effectively managing your drug safety information.

Medical Affairs and Pharmacovigilance Services include:

• 24/7 Medical monitoring
• SAE management
• SAE case narrative preparation
• Safety data review
• Medical data coding consistency review
• Scientific and medical review of Clinical Study Reports, Protocols, Clinical Development Plans

The company you have come to rely on for your clinical trial management needs also provides auditing services in the way Stiris is known for: with quality, collaboration, and while keeping you safe.

Services Offered:

• 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
• Compliance Consulting and Remediation
• Qualification and Due Diligence Audits
• Evaluating Quality Management Systems (QMS) and Standards
  • QMS Gap Analysis
  • SOP authoring and review
  • Gap Analyses
  • Development of Quality Plans and Internal Audit Programs
  • Assist in implementing quality compliance programs

Stiris’ data management and statistics team has successfully supported over 150 clinical trials including early phase studies, large pivotal studies, as well as multiple late phase studies.

Clients both large and small have recognized the strategic benefits of working with our customer focused team and market leading technology.  Some of the qualities that significantly differentiate us include:

• Rapid Execution – consistently meeting or exceeding client expectations on turnaround of all project deliverables.
• Personalized Service – All team members recognize the importance of developing lasting relationships with our clients. Each member of our team strives to achieve the highest level of customer service on each and every project.
• Total Quality Assurance – From our gold standard technology to our rigorous quality assurance processes, we ensure that our clients have the utmost confidence that their data is safe and in good hands.
• Innovative Tools – a variety of tools for both discrepancy management and interpretation of study results have been developed. As such, these tools have been proven to reduce overall study costs and allow non-statisticians to easily interpret an entire study’s results on a single page.

Biostatistics Services:

• Protocol Development
• Sample Size Calculations
• Client Representation at Regulatory Agency Meetings
• Randomization Schedule Preparation
• Statistical Analysis Plan (SAP) Development
• SAS Programming and Independent Validation of Tables, Listings, and Figures
• Interim Analysis Planning
• Topline Analysis Package
• Final Analysis Package
• DMC Statistics Services
• PK/PD Analysis
• Integrated Summaries of Safety and Efficacy (ISS/ISE)
• Statistical Reports
• Statistical Review of Clinical Study Reports (CSR)
• Submission-Ready Services (SDTM, ADaM)

Clinical Data Management Services include:

• Protocol Review
• Trial Master File Set-Up and Maintenance
• eCRF Design and Development (CDASH)
• Subject Diary Design and Development
• Data Management Plan (DMP) Development
• Data Validation Manual (DVM) Development
• Edit Check Programming, Development, and Testing
• Clinical Database Creation, Validation, and Auditing
• EDC System User Training
• Adverse Event, Concomitant Medication, and Medical History Coding
• SAE Reconciliation Between Safety and Clinical Databases
• Data Cleaning and Discrepancy Management
• Database Lock
• 24/7 EDC Help Desk

Whether you’re running your study in North America, or globally, we have you covered with expertise in:

• Strategy development
• Clinical Development Plan Support
• Drug Development Plans
• Representing sponsors
• Regulatory submissions and applications
• Regulatory Life Cycle Management activities
  • Supplemental New Drug Submissions
  • Notifiable Change
  • Annual Drug Notification
  • Yearly Biologic Product Report
• Special Access Program Support

Your Stiris team is dedicated to rapid site activation. Our specialists review each study and individualize the start-up process to address your protocol’s specific needs to ensure the most efficient and effective structure for your study.

Stiris’ start-up services include:

• Site identification
• Feasibility
• Regulatory Affairs support
• Ethics submission
• Essential document dissemination, collection, review and tracking
• Investigator contract closing
• Trial Master File set-up

Stiris is strategically designed to allow you to run your trials globally while retaining quality of people and regional expertise.  Global coverage by a team where your business is important to each of us; where you’ll stay in the forefront and continue to be supported by great teams.  Where your important study is our important study.

Stiris’ collaborative model gives you access to first-in-class global coverage in every service we provide. Our innovative approach affords you proven solutions without compromising quality.

We designed this cost-effective solution to meet growing client demand while retaining our nimbleness to change direction quickly. There is a seamless connection between partners so you retain that single point of contact. Take advantage of our extensive global experience, use of best practices and flexible contingency planning to effectively manage your studies.

Clinical Trial Management Software and Electronic Trial Master Files

Stiris’ Clinical Trial Management System (CTMS) allows you instant access to up-to-the-minute information on the status of each trial. Key features of the CTMS include:

• Web based system – available anytime/anywhere
• Validated system
• Easily configured to meet your requirements
• Highly secure system via SSL
• Validated eTMF
• Fully Functional
  • Key Study Information
  • Site Information
  • Milestone Management
  • Subject Management
  • Regulatory Document Tracking
  • Managing Monitoring Reports
  • Automated Confirmation/Follow-up letters
  • Enrollment Tracking
  • SAE Tracking