SERVICES

Our clients typically reside in Clinical Development, Medical Affairs and Medical Communications groups.

We tailor our services to meet your specific needs and focus our efforts on medical and regulatory communications and strategic consulting that support drugs, diagnostics, and devices throughout the product lifecycle.

We have supported a spectrum of therapeutic modalities (including small molecules, enzyme replacement therapies, and immunotherapies) across disease areas. We are experts in planning, preparing, and submitting clinical trial-based safety, efficacy and pharmacoeconomic manuscripts, and in document preparation for regulatory submissions.

Medical Writing

We work with authors to prepare or edit peer-reviewed publications including:

  • Manuscripts based on pre-clinical and clinical data, observational studies, resource utilization data, and health outcomes research

  • Therapeutic Area and Drug Reviews

  • Abstracts, Posters, and Slide Sets

  • Case Studies and Narratives

 
We partner with clinical teams to prepare or edit clinical trial-based regulatory documents including:

  • Clinical Study Reports

  • Investigator Brochures

  • CTD documents in support of IND, NDA, BLA and

       505(b)(2) submissions


We partner with communication teams to develop or edit internal communication material including:

  • Slide Sets

  • Medical Meeting summaries

  • Advisory Board Summaries

Strategic Consulting

Communication Strategy and

Project Management:

  • Publication Plan development and content review

  • Publication Policy and Regulatory issues impacting communication of clinical trial data

  • Identification of appropriate Journals, Medical Meetings, and Thought Leaders

  • Publication Team, Project, and Contractor Management

  • Publication Updates & Tracking

  • Literature Reviews and Assessments

  • Platform Technology Assessments

  • Environmental Landscape Analysis (key  themes and issues impacting on the development of publication and communication plans