Quality Assurance and Compliance

TransCom attaches the highest importance to quality assurance. Our organizational culture instills the values of high standards in each and every employee. TransCom has developed a one-of-a-kind Quality Assurance Department, the only one of its kind in the world, to ensure top quality translations for the clinical trial industry. Our QA specialists have vast experience in the pharmaceutical and medical device industries as well as in-depth knowledge of regulatory requirements worldwide. Their professionalism directly contributes to quick, cost-effective and successful submissions to ethics committees. 

Compliance with clinical trials regulations

All translation, back-translation and QA procedures at TransCom are conducted in compliance with both GCP-ICH guidelines and client's specific SOPs and requirements.

The QA Department 

TransCom's QA Department is headed by a senior CRA and employs clinical QA specialists who perform the task of making a comparison between the original text and the back translation, in order to achieve full validation. The QA specialist compares the back translation with the original and upon completion of his work the translations are returned to the translators, who make the necessary corrections. Before forwarding to the client, The QA Department conducts an additional examination to ensure full validation of the final documents.

Confidentiality 

TransCom attaches utmost importance to maintaining strict confidentiality of clients' information and documents.

• All of TransCom's staff sign a non-disclosure agreement and if required, a client's NDA as well.
• Each project team has access to their projects only
• All hardcopies are shredded
• TransCom has a high quality computerized security systems