At ClinTec we understand the importance of accurate compliant documentation in the development of your products.
ClinTec’s Medical Writers have medical, pharmaceutical and life science backgrounds and are experienced in producing high quality Phase I–IV clinical documentation across a wide range of therapeutic areas that strictly adhere to ICH-GCP guidelines and local regulatory requirements. In addition, our Medical Writing team can provide high quality dedicated support for the development of your medical device and preclinical documentation.
Our Medical Writers work closely with Clinical Data Management, Biostatistics and Regulatory Affairs departments to provide high quality compliant documentation in an efficient and timely manner. In addition, ClinTec’s Medical Writers are experienced in liaising with medical experts and key opinion leaders to ensure your deliverables are in line with current therapeutic area considerations. Our extensive geographical footprint, including presence in the emerging markets, ensures that your documentation is compliant with the regulations and cultural nuances in these specialised regions. All Medical Writing deliverables are vigorously QC checked and can be produced using ClinTec or client templates.
Our Medical Writing services include, but are not limited to:
|•||Clinical Study Reports|
|•||Patient Information and Informed Consent Forms|
|•||Clinical Development Plans|
|•||CTDs and eCTDs|
|•||Summary of Product Characteristics/Product Information Leaflets|
|–||Manuscripts, Abstracts and Posters|
|•||Quality-review of previously written clinical documentation|