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 compliant with ICH-GCP, ISO 14155, ISO 20926 (IVDR), and ISO 62366 guidelines. Our company has implemented a multi-level quality control system. Medical writing experts are guided by standard operating procedures (SOPs) and work closely with leading.

Medical writing in the clinical trials industry is challenging, as each document must be accurate from both a statistical and medical standpoint while complying with regulatory requirements. Pharmaxi’s medical writers are recognized experts at the national level. They continuously use innovative technologies and resources to handle various tasks. Additionally, they consider the purpose and specifics of each project to provide the most professional solutions.

Pharmaxi’s Medical Writing Services:

Study design and study outline development.
Development of Clinical Investigator Plan (CIP) for medical devices: pilot, pivotal, and post-marketing studies.
Phase I-IV Clinical Study Protocol development and amendments.
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 activities that best suit your project needs while ensuring our proposal is 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.