A CRO (contract research organization) supports some of the life science industries like medical devices, biotechnology, and pharmaceutical industries as business outsourcing enter for services which include R & D (research & development) and clinical trials. The majority of the CRO’s are specialized in providing these services, particularly for clinical trials. One must function where the clinical trials would be successful is the documents accurately to be translated in the required language.
The CRO’s gaining huge work over the last few years as the complexity of drug molecule synthesis its production and development has led many pharma companies to outsource the clinical trials to contract research organizations. Statistics say, in the year 2011, the CRO outsourcing services were used by 27% of top pharmaceutical companies and 47% of small-sized companies. 33 out of 38 drugs approved in the same year were tested by CRO’s.
Countries, where clinical trials are performed, have their own set of regulatory guidelines and the approval procedures. For trial submissions to be approved in global countries, documents like the following patient informed consent form, clinical summary reports, and many others may have to be translated into their local languages. For instance, a clinical research organization that chooses to launch their product in Europe many have to translate into more than 23 languages of the European Union. Hence, this translation business is a large responsibility and the sponsors will be contacting CRO’s for this task thus, in turn, they contact the translation service providers.
Avanteva solutions Pvt.Ltd. OPC is expertise in translating these documents. We translate the following Clinical documents for Clinical companies under Clinical Trial and Research-
- Informed Consent Forms (ICF’s)
- Clinical trial protocols
- Patient surveys and diaries
- Case Report Forms (CRF’s)
- Investigator Brochures
- Adverse Event Reports
- IRB/IEC documentation
- Patient Reported Outcomes Forms (PRO’s)
- Patient recruitment materials
- New Drug & Marketing Authorization Applications
- Patents and Contracts
- Pharmacology & Toxicology Reports
