Our Services

 Home / Our Services / Medical Writing and Electronic Publishing

Your product’s success depends on regulatory-compliant documentation that is well-structured, detailed and thoroughly accurate. You want skilled medical writers who are excellent team players able to respond to shifting timelines and changes in scope of work that characterize medical writing projects

Quality documentation

Ethicare create documentation covering a broad range of therapeutic areas in close cooperation with our Regulatory Consulting and Biostatistics services. Rigorous quality control standards ensure that your documents are accurate and easy to follow. Our medical writers can work independently to produce low-, medium- or high-complexity documents for regulatory submissions and license maintenance.

Development and writing documents

At Ethicare, no project is too large or too small. Examples of documents we can prepare are:

  •  Clinical study protocols and amendments
  •  Subject information leaflets and informed consent documents
  •  Different regulatory environments and industry best practices
  •  Investigator brochures
  •  Investigational medicinal product dossiers
  •  Clinical study reports
  •  Patient safety narratives
  •  Clinical summaries and overviews for worldwide regulatory submissions
  •  Responses to questions from regulatory authorities
  •  Clinical publication manuscripts
  •  Standard operating procedures

Electronic compilation and hyperlinking

Electronic publishing of your documentation enhances readability, user-friendliness and time to approval by generating navigational aids such as multi-level tables of contents, lists of tables, figures and appendices, and extensive cross-referencing and hyperlinking. The final product can be both a paper and an electronic report or dossier.

Electronic submission

Electronic submission of your Common Technical Document can reduce time to approval and provide substantial cost savings on printing, shipping and resource time. The eCTD enables easy navigation around your dossier and provides lifecycle management of your submission when updating and supplementing information.

Management, standardization and training

The quality and completeness of your documentation is of the utmost importance. We can help you achieve it, from initial planning to submission and beyond. If you are short on resources to oversee the documentation process, let us do it for you. Ethicare’s team can develop and manage all your documentation needs. Our special services include:

  • Medical writing resource management
  • Medical writing consulting services for clinical development and project plans
  • Development and maintenance of standards and templates
  • Training your documentation team on medical writing and electronic publishing