Medical Writing and Communications

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World-Class Medical Writing

We provide world-class medical writing expertise across a broad range of therapeutic areas and document types, from preclinical reporting through the drug development life cycle to post-marketing and commercialization writing. 

Our writers develop documents from data sources in various analytic models for a variety of audiences, manage writing projects, and maintain consistency of style and message across multiple documents. They possess strong project management and negotiation skills and support projects with multiple customer contributors and external thought leaders. They drive timelines, organize and lead authoring meetings, and reconcile sponsor feedback across functions to create consistent, scientifically cohesive documents and minimize nonessential customer oversight.

 

  • >5,500 writing projects in past 3 years
  • >200 Professional Writers 
  • ~2,800 standalone quality and editorial reviews per year
  • ~1,900 regulatory documents published per year

 

As well as providing writing services for complete deliverables, we also offer flexible solutions for partnering with customers’ in-house writers to take on specific standalone document-related tasks, providing cost-effective solutions that remove the burden of routine medical writing tasks and allow our customers’ writers to focus on content development. 

All our solutions can be provided as part of full-service programs or as standalone solutions in a functional service partnership model.

We also have a strong quality review department that provides data integrity and editorial reviews for documents produced internally or those from customers’ own writing teams.

 

Services We Provide

Regulatory writing for individual studies:

  • Protocols and amendments
  • Investigational medicinal product dossiers (IMPDs)
  • Informed consent forms and patient information leaflets
  • Clinical study reports (full, abbreviated, interim, and synoptic)
  • Patient-level and event-level safety narratives

 

Regulatory writing across studies:

  • Annual reports
  • Briefing documents
  • Investigators’ brochures
  • Investigational new drug applications (INDs), new drug applications (NDAs), and common technical document (CTD) submission dossiers
  • Regulatory responses
  • Risk profiles

 

Aggregate safety reports (study or program level):

  • Periodic safety update reports (PSURs)
  • Periodic benefit-risk evaluation reports (PBRERs)
  • US Food and Drug Administration periodic line listings
  • Risk management plans (RMPs)
  • Development safety update reports (DSURs)
  • Local safety summaries (LSSs)
  • Signal analyses
  • Clinical overviews

 

Publication writing (study or program level):

  • Medical publications writing

- Primary publications and strategic publication support

- Manuscripts

- Review articles

- Resubmissions and responses to reviewers

  • Assistance with publication planning and journal submission
  • Literature reviews and searches
  • Oral presentations, posters, and abstracts
  • Slide kits

 

Medical editing:

  • Formatting and editing regulatory and publication documents according to appropriate style guide and templates
  • Reviewing documents for grammar, spelling, and style to promote readability and prevent perpetuation of errors
  • Providing quality review services, comparing source data with document content to ensure accuracy and consistency
  • Preparing publications for submission to a new venue
  • Complete primary publishing: ensuring submission-ready, finalized regulatory documents compliant with electronic common technical document standards

 

Specialized services:

  • Medical information letters
  • Advisory committee slide creation
  • Submission support
  • Document project management
  • Regulatory document finalization and publishing
  • Clinical trial transparency and disclosure
  • Lay language documents
  • Document redaction
  • Clinical trial registry records support
  • Regulatory submission bibliographies

In addition, we have expertise across 19 therapeutic areas. 

 

Thought Leadership

Many of our medical writing associates and members of our leadership team are active speakers and participants in forums within the medical writing community, including national and chapter conferences of the Drug Information Association, Drug Information Association Medical Affairs and Scientific Communication, American Medical Affairs and Scientific Communication, and American Medical Writers Association, as well as internal customer summits. Recent topics presented by our writers have included:

• Latest developments in clinical trial transparency

• Leadership and writing in a global environment

• Innovation in data presentation

• Models for successful outsourcing

• Effective document project management

• Structure of and methods for writing publications

• Leadership in a global environment

• Successful style guide creation

 

FSP Model

In addition to providing support on an individual clinical trial or project basis, we have extensive experience in building functional service provider relationships (FSPs), offering collaborative and strategic solutions that provide layers of additional benefit to our customers. 

The FSP structure builds on our clinical and technical expertise to deliver not only high-quality deliverables, but  also provides dedicated resources capable of fully integrating with customers’ teams, providing consistent compound expertise. Our committed FSP leadership provides a performance management of the staff, focusing on developing and retaining personnel within the partnership; ownership of staff productivity; and collaborative process optimization, engaging with customers to explore opportunities for innovation and increased efficiencies within the partnership.

Perspectives: 
  • Functional Service Provider
05.20.17