Medical Writing
Our Medical Writers come from medical, pharmaceutical and life science backgrounds with strong clinical research foundations and EMWA (European Medical Writers Association) training. They will quickly understand the objectives of your project and are up to the challenge of delivering medical writing deliverables on time and to high quality.
ClinTec has access to a large clinical research resource pool as well as specialists throughout the world allowing our Medical Writing team to liase with medical experts in a given field ensuring that they have the latest knowledge at their fingertips.
Medical Writing Deliverables
| Literature search and review | Quick searches and recommendations for scientific bibliography. |
| Clinical trial protocols | Experience in Phase II, III and IV protocols in respiratory medicine, oncology, neurology and dermatology, development and review. Our protocols have received EU, TGA and MHRA approvals. |
| Case report forms (CRFs) | Experience in the development and design of CRFs. Our writers collaborate with Data Management and provide suggestions on data fields required to capture all data as per protocol. Our writers are fully trained in software applications used to create professional CRFs and also have input during the creation of the CRF completion guidelines. |
| Patient Informed Consent Form and Subject information sheets | We comply with ICH-GCP and local regulatory requirements to produce documents that are not only easily understood by patients but are also satisfying the strict standards set by Ethical Committees. ClinTecs’ global presence also allows for in-house translation of such documents in most countries. |
| Clinical study reports (CSRs) | Experience in writing ICH E3 CSRs in the fields of Anti-Infectives, Haematology, Dermatology and Neurology. Our CSRs comply with regulatory requirements and have been created for MHRA and EU regulatory submissions. |
| Manuscripts for publication | Experience in writing manuscripts for journal publications in Ophthalmology and Anti-Infectives. Writers are trained in critical appraisal of literature and ICMJE guidelines. We conform to the EMWA guidelines on professional medical writers (Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin 2005;21(2):317-22.) |
| Position papers | Conduct extensive literature searches in various therapeutic areas and provide a position based on available data. |
Other documents that ClinTec Medical Writing can develop include:
- Investigator brochures
- Safety Reports and SAE narratives
- Summary of Product Characteristics (SmPC),
- Product Information Leaflets (PILs)
- Development of Abstracts and Poster Presentations
- Conference/Symposia highlight bulletins
- Product Monographs
