Octagon's Holistic Approach
Octagon offers a comprehensive suite of services that span the entire clinical research and development lifecycle. We employ extensive domain knowledge in every engagement to help enhance deliverables, address pressing issues and position you for the future. A future that includes seamless access to your data, a transparent view of your processes, e-Sub ready content, parallel-processing of deliverables and fully-integrated functionality across departments.
Our practice for delivering services and technology solutions truly sets us apart from the competition. You'll see the difference in how we approach every client engagement. Our experts will work closely with you to develop documented processes, transition strategies and capability roadmaps to ensure that your cross-functional processes are optimized. Our technology solutions will empower your team by automating the delivery and presentation of critical process information, providing standards for professional authoring processes and enabling viewing and verification of eCTD compliant submissions. Our solutions provide a foundation that offers recurring value across Clinical R&D.
Our Regulatory Affairs and Operations Experts advise clients on electronic submission strategies that incorporate practical experience and facilitate approvals by global health authorities.
Regulatory Affairs
Regulatory Operations
Submission Stewardship™
SPL Stewardship™
Global eCTD Guidance Interpretation
eCTD Solutions
eSub Training
Our Clinical Information Management Team is pioneering the clinical information workflow from collection to submission based on evolving industry standards, including CDISC. We offer expert consulting, training and legacy conversion and business process outsourcing solutions.
Clinical Data Strategies
Clinical Data Operations
CDISC Training
CDISC Solutions
Data JumpStart
ViewPoint®, Octagon's enterprise submission process management solution, provides visibility and control over your most critical and complex processes. Octagon?s eCTD Viewer and Validator inject eCTD capabilities into electronic submission processes.
ViewPoint®
ViewPoint® FUSE
eCTD Viewer and Validator
Our eSub capabilities include consulting services for the creation of authoring standards, StartingPoint™ Global eCTD Template Suite, which includes over 165 eCTD authoring templates and our eCTD JumpStart package which provides document standards and processes to create high-quality eSubmission ready documents.
eSub Capabilities
StartingPoint®
eCTD JumpStart™
Our Training Solutions minimize risk and ensure knowledge transfer throughout your team and your processes.data-jumpstart.html
eSub Training
CDISC Training
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