Consulting: Global Document Management

CSI will assist with:

• Gap analysis
• Development of new processes and standards
• Development of Requirements Specification for technology
• Support for technology and vendor selection
• Technology and business process implementation

CSI helps companies prepare for e-submissions (e-CTD) by:

• Implementing "Standardized Document Development" that focuses on (corporate) processes that cross the organization.
• Developing procedures such as authoring, review and approval, standards, and templates.
• Provide template training and eSubmission awareness training for authors and project team members.

Consulting: Submission and Project Management

CSI supports dossier management that includes:

• Assistance in developing the "Document Inventory".
• Project planning and project management for dossier development.
• Execution of the electronic or hard copy submission.
• Work with project teams and regulatory professionals to ensure timely and accurate submission preparation and filing.

Out-of-the-box: Standard Processes and Procedures

CSI offers an “out of the box” process solution for document and submission management. Standard Processes and Procedures (SOPs) are available that can be customized for each organization. They include SOPs such as archiving, authoring and managing documents.

These processes can be adapted to suit any document management environment; file server, Documentum, Livelink etc.

Out-of-the-box: Templates

CSI's FrontEnd™ DocTemplate© authoring tool and eCTDirect™ templates are out-of-the-box solutions for CTD submissions and documents. We have templates for all CTD summary documents (Modules 2 and 3) as well as for major document types such as Clinical Study Report, Investigator Brochure and the Stability Report.

Customize: Templates and Standard Operating Procedures (SOPs)

All our templates and procedures can be customized to meet your requirements. Do it yourself, or we can do it for you.

Our SOPs provide you with steps that can be used in your organization [as is] or may be adapted to suit your specfic environment. A great starting point for your own SOP process development. They will easily get you on your way.