Medical Writing

Medical writers at ClinTec International are qualified, trained and can quickly grasp the issues of a project. We understand the urgency and the need for your medical writing work in drug development and are up to the challenge of delivering medical writing projects on time and with high quality. Our medical writers come from medical, pharmaceutical and life science backgrounds with strong clinical research foundations and EMWA (European Medical Writers Association) training.

The types of challenges faced and the way we tackle them:

short timelines – quickly find new resources or work over time
new therapeutic areas – talk to medical experts in the field to quickly gain knowledge
new client software – acquire training in time

The main documents that we develop are:

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 a number of projects with thorough protocol understanding. We not only execute but provide suggestions on data fields required. Our writers are trained in software applications to create professional CRFs from protocol to the desk of the investigator, along with an instruction guide on CRF completion.
Informed consent documents and subject information sheets	We comply with ICH-GCP and local regulatory requirements to produce documents that are easily understood by patients and pass ethical approval easily. Our regional reach allows in-house translation in most countries.
Clinical Study Reports	We have experience in writing ICH E3 final study reports 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	ClinTec International medical writers have experience in writing manuscripts for journal publication 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 we can develop are:

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

Training Materials for sales force – slide kits and manuals.

Download Medical Writing Brochure