inSeption’s future is secure, as we garner new business from existing clients, while continuing to attract new clients. In addition, we are busy expanding our service offerings to include new areas of expertise.
Expanding Our Capabilities
The scope of our Regulatory Operations Team has broadened recently to provide submission-level publishing to a growing number of clients, in a growing number of formats. Using FDA’s Electronic Submissions Gateway (ESG), we have successfully transmitted 50+ submissions since the beginning of this service in March 2020. Most recently, we submitted an Electronic Common Technical Document (eCTD) Clinical Trial Application (CTA) to Health Canada as well as an Orphan Drug Designation Request (ODDR) to FDA. This experience has opened the door to ISG providing continued support to our clients for their upcoming applications.
One of the key services our Regulatory Operations team offers to inSeption’s clients is guidance to help them avoid health authority refusals and/or delays in drug approval. We provide source document formatting, study report compilation, PDF publishing, and submission preparation services in accordance with stringent FDA, ICH, Health Canada, and other applicable regional publishing and submissions requirements.
Expanding Our Technology
To support the growth of the Regulatory Operations Team’s services, we plan to expand our technology capabilities by implementing a new Submissions Publishing system. The team has selected a system and the implementation is planned for next quarter. This system will be used to prepare submission structure, to compile and validate submissions, and to allow clients the opportunity to review submissions before they are finalized. The system will support publishing in electronic formats accepted by the agencies around the world, including the United States, Canada, and Europe.
OpenAir was rolled-out about a month ago for timesheet entry, and we wanted to relay our appreciation to all users who are now up-to-speed and entering time successfully each week. Additional thanks to those of you who have provided us with insightful questions and feedback, which helped us revise the User Guide with several key updates. If you have not yet received a copy, please email a request to Openair_Requests@inseptiongroup.com. If you have any questions about the system or time entry, please don’t hesitate to email us at the same address.
StartingPoint Template information sharing sessions were provided to the Medical Writing team on 2 dates (June 23 and 24), conducted by our Regular Operations and Quality Control teams. These sessions provided an overview of the StartingPoint template technology, specifics about inSeption’s template, and review of the application’s functionality. If you are not familiar with the StartingPoint template, it is an electronic Microsoft Word template that provides a macro-enabled toolbar. It creates a formatting ‘backbone,’ for documents, to ensure that pre-determined heading and body styles, content formatting, and one-click error checking are easily accessible for any document to which it is applied.
For inSeption’s employees, our IT team, GO2, provides a full range of technology expertise and solutions on behalf of inSeption. As such, in the event of an IT-related issue or concern, please contact GO2 directly.