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