Clinical examinations and clinical studies are necessary in the development of new drugs and the approval of their use by relevant authorities. The challenges for outsourcing companies in clinical research lie in the fact that a large number of tests are performed in a number of different centers and countries which requires the preparation of large quantities of sensitive documents in several languages, often in a very short time.
The need for translation of documents for clinical studies appears immediately after the completion of text protocols. Documents intended for researchers, such as protocols or brochures for the researchers, are characterized by highly professional terminology, while the papers for patients who participate in the study requires a specific, precise language adjusted for a layman to understand the text.
Our team of highly skilled staff is qualified to respond very quickly to the high-quality requirements of these very demanding projects. This relieves the client and his human resources of a time and energy consuming task, which usually has a favorable effect on the client’s business.
The terminology we use is strictly controlled and founded on legislation and documentation of the Agency for Drugs and Medical Devices of Serbia. Long previous experience in working with such documentation helps us to deliver to our clients consistent high-quality translation.
Along with these translation services, we also offer pharmaceutical companies and contracting research organizations the following services:
- Clinical Monitoring is the basis of any successful clinical trial. 2GL’s clinical trial monitors come from either a Medical or other advanced Life Science background
- Printing and adequate reviewing of documentation in accordance with regulations of local ethical committees and ALIMS.
- Start-up activities including the following:
- Elaboration of feasibility studies for the territory of Serbia, Croatia, Slovenia, North Macedonia, Montenegro and Bosnia and Herzegovina.
- Submission of documents to relevant authorities, if the contracting party is not a legal entity in these countries (the local ethical committees, the Agency for Medicines).