Clients
in the Pharmaceutical Industry:
GlaxoSmithKline, AstraZeneca, INC Research, PPD Global, Orion CRO, Ockham
Development Group
Related Links
Clinical trials are generally considered to be medical or health-related
research studies that test how well new medical approaches work in people. Each
study answers scientific questions and tries to find better ways to prevent,
screen for, diagnose or treat a disease. The trial follows a carefully
controlled protocol, a study plan that describes what will be done in the
study, how it will be conducted, and why each part of the study is necessary.
Clinical trials should be conducted in accordance with the ethical
principles stated in the Declaration of Helsinki which are consistent with Good
Clinical Practice (GCP) guidelines. The International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH), a unique project bringing together the regulatory authorities
of Europe, Japan and the United States and experts from the pharmaceutical
industry in the three regions, developed guidelines in order to provide
clinical trials with a unified standard and provide public assurance that the
rights, safety, and wellbeing of trial subjects are protected. The guidelines
take into consideration the current good clinical practices (GCP) of the
European Union, Japan, and the United States, as well as those of Australia,
Canada, the Nordic countries, and the World Health Organization (WHO).
Bringing a new drug to market is a lengthy and expensive process.
Pharmaceutical companies can spend up to 10 years and more, and over $500
million to get a new drug to market. Since more and more clinical research and
drug manufacturing are being done in multiple countries and in multiple
languages, quality language services can help bring a drug to market faster and
can help streamline the clinical trial process. Translation may be required at
many stages, including clinical research, regulatory submission and review,
production and marketing. Moreover, expansion of the EU block into new member
countries is also driving increased demand for medical and pharmaceutical
translation services.
Global Translation is a leading provider of specialized translation services
to leading pharmaceutical companies and contract research organizations (CRO).
The documents we translate include:
- Patient Information Leaflets (PIL)
- Informed Consent Forms (ICF)
- Doctor and Patient Guides
- Case Report Forms (CRF)
- Patient Questionnaires
- Drug Inserts
- Drug Study Labels
- Clinical Protocols
- Regulatory Documents
Customers in the Pharmaceutical, Medical Device and Healthcare industries
have come to rely on our team of subject-matter experts for even the most
complex translations. Our human resources include linguists with experience in
genetics, biochemistry, biotechnology, chemistry, pharmacology, toxicology and
more.
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