In line with ICH standards and by using our model or the sponsor's document templates, Eurofins Optimed covers the folowing areas:

In preparation phase:

At the end of the study: Clinical study reports in line with ICH E3

(Electronic) Common Technical Documents (eCTD)

Abstracts / Posters / Publications

Post-study meeting

Synopsis / Protocols (clinical trial, non-interventional studies or clinical investigational plan for medical devices)

Informed Consent forms / Patient Information results..),

Case Report Forms / Patient Diaries

ICH guidelines

21 CFR part11

ISO 9001: 2008 Certification for al activities: set-up, conduct, folow-up of clinical trials and data analysis

GCP & GCDMP

EMA

CTD

EN ISO 14155: 2011

Medical writing

Regulatory and guidelines expertise: