Medical writing

Pharmaxi's medical writers have the scientific expertise and therapeutic knowledge required to provide medical writing services that deliver structured and accurate documents that comply with ICH-GCP, ISO 14155, ISO 20926 (IVDR), and ISO 62366 guidelines. Our company implemented a multi-level quality control. Medical writing experts are guided by standard operating procedures (SOP) and work closely with leading biostatisticians and key-leader opinion physicians in Ukraine and Poland.

Medical writing in the clinical trials industry is challenging since each document should be accurate from a statistical and medical standpoint and compliant with the regulatory requirements. Pharmaxi's medical writers are involved as experts at the national level. They constantly use innovative technologies and resources to fulfill various tasks. In addition, they keep in mind the purpose and specifics of each project and provide the most professional solution.

Pharmaxi's Medical Writing Services:

  • Study design and study outline development.
  • Development of Clinical Investigator Plan (CIP) for medical devices: pilot, pivotal, and postmarketing studies.
  • Phase I-IV Clinical Study Protocol development and amendments to them.
  • Informed Consent Form (ICF) development, including local language ICFs (prepared and reviewed by the relevant country).
  • Development of Patient Information Leaflet.
  • Investigator's brochure development.
  • Case Report Form (CRF) creation.
  • Standard Operating Procedures (SOP) development.
  • Serious adverse event narratives.
  • Abstracts, manuscripts, and posters creation.
  • Case narratives creation.
  • Scientific publications for peer-reviewed journals.
  • Translation of regulatory documents.
  • Pre- and post-approval aggregate safety reports development.
  • IND summary sections and special reports creation.
  • Creation of phase I-IV integrated Clinical Study Reports (according to ISO 14155, ICH E3).

Our main purpose is to offer you the activities that best suit your project needs, while ensuring our proposal is reasonable as well as both cost and time efficient.

Contact us with your questions or concerns. We offer a free half-hour consultation with a clinical trial expert to discuss your request.

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