Additional Services
We provide comprehensive support to our clients in various aspects of clinical research and project management. These services range from feasibility, study rescue services to our Signature Audit FACT CHECK Two Phase Clinical Trial PM Oversight Program offering additional support to ensure successful delivery of the Trial.
Regulatory Affairs and Compliance
Our team of experts can navigate the complex landscape of regulatory approvals, ensuring that your trials are conducted in compliance with local and international regulations. We handle submissions, approvals, and interactions with regulatory authorities.
Site Selection and Feasibility
Leveraging our extensive network, we identify optimal investigational sites and conduct feasibility assessments. Our goal is to enhance patient recruitment, retention, and overall trial efficiency.
Clinical Site Support
We offer on-site training and monitoring to ensure sites are well-equipped to execute protocols. This support strengthens site relationships, improves data quality, and accelerates study timelines.
Patient Recruitment and Engagement
Our innovative patient recruitment strategies engage potential participants effectively, enhancing enrollment rates. We're skilled in crafting messaging that resonates with diverse patient populations.
Quality Assurance Audits
Rigorous quality assurance audits performed by our experts ensure GCP and regulatory compliance. Our recommendations drive continuous improvement in trial conduct.
Protocol Development and Optimization
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Vendor Selection and Management
We assist in identifying and managing vendors, ensuring seamless collaboration while maintaining quality and adherence to timelines.
Health Authority Interactions
Our experienced team supports interactions with health authorities, including pre-IND, pre-CTA, and FDA meetings, providing strategic guidance and documentation support.
Publication and Communication Strategy
We collaborate with your team to craft effective publication and communication strategies, ensuring your trial's results are disseminated effectively to both scientific and public audiences.
Adaptive Trial Design
Leveraging our expertise, we can guide you through the intricacies of adaptive trial design, enabling you to make real-time adjustments for optimal outcomes.
Global Trial Management
Our international experience equips us to manage trials across multiple regions, overcoming challenges related to diverse regulatory environments and cultural considerations.
Post-Marketing Surveillance
Extend our support beyond trial completion with post-marketing surveillance services, ensuring ongoing safety and efficacy monitoring.
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