We work with your medical and scientific affairs teams to do comprehensive literature searches and develop scientific communication platforms, core slide libraries, and oral presentation decks. 

You can use our team to implement strategic publication plans, including writing abstracts, posters, primary and review journal articles, and publication extenders (eg, plain-language summaries, graphical abstracts). 

We can augment your team by conducting competitive intelligence at annual meetings; preparing advisory board slides and executive summaries; and writing standard response letters and responding to other medical information requests. 

We keep up with industry best practices and guidelines regarding authorship and transparency and can consult with and train your team on the latest requirements.

In the early phase, we can assist your regulatory affairs, clinical operations, and program management teams with medical literature searches and reviews, regulatory gap analyses, and initial and annual updates of INDs/IMPDs. 

As development progresses, we can support your team in the preparation of protocols and protocol amendments, Investigator Brochures (IBs), phase I-III Clinical Study Reports (CSRs) (including legacy and backlog CSRs needed for compliance), specialized documents like Orphan Drug Designations (ODDs) and Pediatric Investigation Plans (PIPs), and briefing books and regulatory response documents. 

When it's crunch time, we are all-in with you and your team to assist you with all of your NDA, aNDA, and BLA submission documents. We've done many clinical pharmacology and efficacy and safety modules, including integrated efficacy and safety analyses, and specialty documents, such as the question-based clinical pharmacology review document.

We can help you  prepare small or large batches of patient and event-level narratives; aggregate safety reports (eg, DSURs, PADERs, PBRERs, and ASRs); risk mitigation strategies/plans (REMS, RMP); and systematic and narrative literature reviews.

Let us help you catch errors and inconsistencies in your documents before management or medical-legal-regulatory committee review and prior to submission to regulatory or other authorities or for publication/ dissemination. For publications and slide decks, we can provide full fact checking and annotation services.

We always check data against sources, but we are also experts at ensuring internal and between-document consistency in terms of content, style, and format. We can use your company's document-specific QC checklists and verification forms, or we can develop and/or customize our own. 

What we need from you before review and sign off--1) adequate time to review (we are fast but require at least 1 full business day or more for review depending on document length and complexity); 2) a static document that is not being worked on by team members during QC review; and 3) for sign-off, a verification step that allows us to check whether errors or requested changes were made and, if not, a suitable explanation for why not was provided.

From strategic asset reviews to building core slide libraries, print and online training modules, objection handling materials, and annotated journal articles or package inserts, we can work collaboratively with your team to create all types of medical/scientific sales and MSL training materials.