The concept of outsourcing submission services is not new; what is new is ISI’s approach to meeting your needs. Our Submission Consultants will assess your state of submission readiness to help you decide the best short- and long-term solutions as your organization grows. Since our software and services span the spectrum of full-submission services, you can rely on ISI to teach you how to do the work yourself while we’re doing the first one for you.
Image Solutions offers a comprehensive package of consulting services. ISI Submission Solutions Consultants can advise you and assist you with:
- Agency support. ISI's consultants are experienced with agency liaison activities, to help you with all of your regulatory operations questions, pilots, or demos.
- Overall submission management and coordination amongst your various functional groups and other outsourced partners, with support for functional-group Project Managers
- In-house needs assessments and process gap analyses
- Staff augmentation, to complete specific tasks required at key stages in the submission process
- Document mapping to submission sections, tracking of submission documents, and timeline and resource management
- “Best practices” for document generation, management, and preparation for submissions
- Interpretation of ICH guidelines and agency guidance
- And finally, development of business processes and the creation of associated standard operating procedures (SOPs), to help your personnel learn to function independently as you increasingly integrate new technologies into your existing environment
Increasing the knowledge base throughout your organization and among your other preferred outsourcing partners is the key to achieving best-practice results. Most sponsors are not able to keep up with the rapidly changing submission guidances and regulations. Submissions are ISI’s core competency, and we, as a necessity, must keep up with the changes in regulatory environments. Our services will empower you to benefit from what we can share with you.