OVERVIEW
Silvertree BioLife offers a range of tailored service packages designed to simplify and accelerate the clinical trial journey for start-ups and emerging biotechs. Our approach provides cost-effective, high-quality solutions, ensuring compliance, efficiency, and expert guidance at every step of the trial process.
Designed for companies conducting research in the U.S. or entering the U.S. regulatory landscape and/or Canada, our services allow clients to dedicate their resources to advancing their research while we help manage the intricacies of clinical operations and quality assurance.
Service Packages
Virtual ClinOps Office
The Virtual Clinical Operations Office is designed to provide organizations with expert-level clinical operations support on an ongoing monthly basis without the need for a full-time hire.
Scope of Services
Provides flexible, on-demand expertise in the following areas:
- Clinical Trial Planning & Start-up
- Clinical Trial Management & Oversight
- Site Management Support
- Clinical Trial Monitoring
- Compliance and Risk Management
- Vendor Qualification, Selection and CRO Oversight
- Study Documentation and Reporting
- Quality Management and SOPs for Outsourced Clinical Trials
Communication & Deliverables
Initial Consultation: A kickoff call to set priorities and define deliverables for the month.
Regular Updates: Weekly status emails or brief check-in calls to discuss progress and adjust priorities.
End-of-Month Summary: A report summarizing activities completed, hours used, and recommendations for the next month.
GCP Gap Analysis
The GCP Gap Analysis is designed to help organizations identify and address gaps in their clinical trial processes to ensure compliance with Good Clinical Practice (GCP) standards and regulatory requirements.
Scope of Services
- Review of Trial Documentation
Includes protocols, informed consent forms, monitoring plans, etc. and eTMF documents. - SOP and Process Review
Evaluation of Sponsor, CRO and other vendor SOPs and processes to ensure alignment with GCP standards and regulatory requirements. - Site-Level Gap Assessment
Evaluation of site processes, training, and documentation for compliance. - Risk Identification and Prioritization
Analysis of non-compliance and operational risks with prioritized recommendations. - Actionable Recommendations and Corrective Action Plans
Clear, tailored solutions to address identified gaps and ensure adherence to GCP standards.
Communication & Deliverables
Initial Consultation: A discovery call to understand the organization’s goals and define the scope of the gap analysis.
Findings Report: A detailed report highlighting gaps, compliance risks, and prioritized recommendations.
Follow-Up Support: Optional consultation to assist in implementing corrective actions and monitoring compliance improvements.