Clinical Trials

Clinical trials are the most time-consuming and labor-intensive part of the approval process for a new drug. Because of this they are often undertaken in multiple countries simultaneously. Clinical trials involve hundreds or thousands of discrete documents and modular data prior to completion for approval of a marketing authorization.

International clinical trials (Phase III, sometimes Phase II), require large amounts of local language translations as e.g.:

Before International Trials

Investigator Brochures
Research Protocols
Package Label
Package Information Leaflet (PILs)
Trials information for subject / Informed consent forms (ICF)
Pre-trial monitoring report
Medical / laboratory / technical procedures / tests  

During International Trials

Trial Monitoring Reports from Investigator
Requests For Clarification (RFC)
Adverse Reaction Reports (ARR) Questionnaires / Subject Screening Logs
Updates of medical/laboratory/ technical procedures/tests,
Substantial Protocol Amendments
Any other written information to be provided to the subject

After an International Trial

Final Trial Close-out Monitoring Report
Treatment Allocation and Decoding documentation
Final Report by Investigator to Ethics Committee where required, and where applicable, to the Regulatory Authorities
Clinical Study Report  

Implementing SDL global information management best practices help pharmaceutical companies to

Avoid language related mistakes
Mistakes can cost huge sums of wasted money, cause massive time-to-market delays, expose pharma to dangerous liability situations, waste irreplaceable resources and kill or badly damage customers

Improve substantially quality of translations
Meaning less exposure to liability caused by incorrect or misleading information and faster time to market through less review, negotiate and corrections (and even missed deadlines) throughout the process.

Save time
Meaning increased revenue for when drugs are authorized by increases in patent protected sales period.

Improve process efficiencies
Human resources engaged in pharmaceutical translation coordination, translation, translation outsourcing and translation review are skilled, unique scientific resources that are better employed in valuable R&D processes. SDL global information management systems allow valuable resources to minimize their involvement with translation related processes.