Our medical writers have the scientific expertise and therapeutic knowledge required to provide medical writing services to create structured and accurate documents that fully comply with ICH-GCP, ISO 14155, ISO 20926 (IVDR), and ISO 62366 guidelines. They are guided by main standard operating procedures and work closely with leading physicians and biostatisticians. The company implemented a multi-level quality control.
Medical writing in the clinical research industry is challenging since any document should be compliant with the regulatory framework and solid from a statistical and medical standpoint. Pharmaxi's medical writers are involved as experts at the national level. They constantly use innovative technologies and resources to fulfill your tasks. Moreover, they keep in mind the goals and specifics of each project and offer the best solution.
Pharmaxi's Medical Writing Services include:
- 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 goal is to provide you with the services that best suit your needs, as well as to make our offer reasonable, time- and cost-efficient.
Contact us to discuss any questions or concerns. We kindly provide a free half-hour consultation with our expert to discuss your request.