We request a line-item quote for IND writing and formatting support for a new molecular entity with a target filing in 2021. Details of responsibilities, documents within scope, and estimated timelines are below.
Please provide an estimated number of resources (eg, single or multiple contributors). Due to the training requirement for our document management system, we prefer a consistent 1-2 resources. Visterra has annual IND targets which will require the same support with a different timeline.
· Writing support for Module 2.4, 2.6.1, 2.6.2, 2.6.3, 2.6.4, 2.6.5, 2.6.6,2.6.7 (PK, Toxicology and Pharmacology sections of IND) such as collating info from vendor reports and internal reports, populating tabulated summary documents.
· Module 4 reference management. Ordering references from RightFind, collating documents and loading them into our document management system.
· Formatting support of Module 2 section (listed below) of regulatory documents
· Formatting support of Module 3
· Formatting and pre-publishing of internal Module 4 reports (approximately 5-10 reports)
Documents will be prepared and archived in a document management system, a customized system based on Documentum Access to this system will require 9 e-learning modules of with an estimated time to completion of ~6 hours.
· Module 2 and 3 documents will be authored, reviewed, and approved in EDMS
· Module 4 reports will be formatted and finalized outside of the document management system and archived in EDMS for submission.
2 Estimated Project Plan and Timelines for Work
Number of drafts and estimated timelines may be estimated from this section. Detailed timeline is subject to change based on data availability.
see attached for more information