What information is needed to generate a project proposal?
Project proposals may be presented based on an hourly rate with an estimated total project charge, or as a flat fee that incorporates milestone payments.
How is billing structured?
Projects may be billed based on an hourly rate or as a flat fee. Projects that include an hourly rate are invoiced monthly, usually on the first business day of each month. Projects that include a flat fee are invoiced upon completion of prespecified milestones.
What is needed before prepartion of a submission document can be initiated?
Shells for various submission documents can be produced once copies of protocols, protocol amendments, statistical analysis plans, and other supporting materials have been received. Additional development of the documents cannot begin until complete information becomes available.
What are the timeline elements associated with the production of documents?
The timeline is dependent upon both the scope of the project and the complexity of the document. Typically, the timeline includes the number of desired review cycles and is predicated on the timely receipt of materials necessary to produce the individual documents.
In what format are documents delivered?
Where applicable, authored documents follow regulatory agency requirements, comply with ICH guidelines, or conform to journal specifications. All final documents are supplied in Microsoft Word format (*.doc or *.docx, as requested by the client) and, when included in the project scope, final documents may also be supplied in an FDA-compliant, portable document format (PDF). If desired, Clinical Study Reports may be published as granulated, FDA/ICH-compliant, eCTD-ready PDFs. Graphs and other figures intended for inclusion in a manuscript are delivered in JPEG or PNG format, as encapsulated postscript files (EPS), or as PDFs, based on client needs and journal requirements.
What assistance can be provided during the clinical development process?
Based on field experience conducting clinical research studies dating back to 1992, advice and consulting regarding study design and best-practice procedures may be provided. Illuminated Research also provides medical writing support associated with the preparation of investigator brochures, study protocols, case report forms, source documents, and informed consent/assent documents. Finally, assistance with the preparation of responses to regulatory authorities and the preparation of regulatory agency briefing materials may also be provided.
