Clear Documentation for Better Clinical Research
Our Services
A structured source documentation package designed to translate your study protocol into clear, site-ready documentation tools.
This package provides essential documentation resources to support consistent study conduct, accurate data capture, and protocol compliance at the site level.
Includes:
• Informed consent documentation template
• Eligibility (inclusion/exclusion) verification tool
• Concomitant medication and therapy log
• Visit documentation worksheets aligned with key study procedures
• Randomization and investigational product documentation (if applicable)
Designed to:
• Support consistent documentation across study visits
• Reduce documentation errors and protocol deviations
• Provide clear documentation tools for clinical research coordinators and investigators
• Improve audit and inspection readiness
An expanded source documentation package that includes core protocol-aligned documentation along with additional operational tools and support for study updates.
Includes everything in the Core Package, plus:
• Study tracking logs for enrollment, visits, and protocol procedures
• Additional documentation tools to support study workflow and coordination
• Up to two (2) protocol amendment updates to maintain alignment with study changes.
Designed to:
• Support ongoing study management and documentation consistency
• Adapt documentation tools as protocols evolve
• Provide additional operational support for research teams
A full-service source documentation package designed to support both protocol implementation and ongoing study management through structured documentation tools and advanced operational resources.
Includes everything in the Enhanced Package, plus:
• Study visit window calculators to support accurate visit scheduling and compliance
• Expanded tracking tools for study coordination and oversight
• Up to four (4) protocol amendment updates to maintain alignment with evolving study requirements
Designed to:
• Support complex or multi-visit studies
• Improve visit scheduling accuracy and protocol adherence
• Provide comprehensive documentation tools for ongoing study management
• Adapt documentation as protocols evolve throughout the study lifecycle
Schedule your appointment
Schedule a consultation to review your study protocol, documentation needs, and workflow considerations. SourceDoc helps translate complex protocols into clear, site-ready documentation tools that support compliance and consistency.
About
our company
SourceDoc LLC was established to address a common challenge in clinical research — translating complex study protocols into clear, structured source documentation.
Across clinical research organizations, studies often encounter issues such as protocol deviations, missing data, and documentation inconsistencies. These challenges frequently stem from the difficulty of converting increasingly complex protocols into practical, site-ready documentation tools.
Research coordinators are responsible for executing detailed study procedures while managing significant operational demands. However, the development of source documentation — a critical component of study execution — is often performed under tight timelines and with limited structured support.
SourceDoc was created to provide a more structured approach.
By developing protocol-aligned documentation frameworks, SourceDoc helps research teams capture required data points clearly, support consistent study execution, and reduce the risk of documentation errors and protocol deviations.
This approach supports:
• More complete and accurate data capture
• Improved consistency in study documentation
• Reduced protocol deviations and missed procedures
• More efficient study workflows
Ultimately, SourceDoc enables research teams to focus more time on patient care, recruitment, and successful study execution.
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