Expert Protocol Writing, Management & Reporting
Trust Versiti Clinical Trial Services to deliver expertly crafted clinical trial protocols, streamlined management processes and insightful reporting to guide your research to success
Protocol Writing
Versiti Clinical Trial Services specializes in creating clear, concise and compliant clinical trial protocols tailored to your study's objectives and regulatory requirements. From drafting initial protocols to addressing complex study designs, we ensure your trial is built on a solid foundation.
Protocol Management
With robust systems and experienced personnel, we oversee the seamless implementation and management of clinical trial protocols.
Our services include:
- Regulatory compliance management: ensuring protocols meet FDA, EMA and global standards.
- Amendment handling: managing protocol changes effectively without disrupting timelines.
- Cross-functional coordination: facilitating communication between sponsors, investigators and site teams.
Reporting Services
We provide accurate and timely reports to meet regulatory submission needs and inform stakeholders. Key reporting capabilities include:
- Data safety monitoring board (DSMB) support: delivering critical reports for data integrity and safety.
- Trial outcome summaries: compiling and presenting findings for clinical and regulatory audiences.
- Regulatory communication: Preparing comprehensive updates for submissions and interactions with governing bodies.
For more information on our services, visit our affiliate page at PearlPathways.com.