Case Study: SpineBiopharma

Japanese and Korean into English clinical translation services of Phase 2 Studies for the Federal Drug Administration (FDA)

The challenge: 

Provide Japanese and Korean translations for phase 2 clinical study for non-opiate, non-surgical therapies for the treatment of chronic low back pain (CLBP) caused by degenerative disc disease (DDD).  Global Link was presented with thousands of pages of scanned and hardcopy files that needed to be accurately translated and certified for approval by the FDA.  The delivery of the final clinical translations was required to adhere to the FDA’s short fuse deadline.

Our answer: 

• Prepped and formatted all documents, creating editable text for the language teams.

• Global Link selected a world-class team of native linguists with subject matter expertise in Biopharma and clinical translations.

• Developed a three-step workflow process comprised of translators, editors, and project managers.

• Leveraged our state-of-the-art translation tools, which sped up the process and allowed the team to deliver fully proofed content on time and on budget.

• By following Global Link’s rigorous translation protocols, we were able to certify and attest to the final clinical translations presented to the FDA.

The Results:

1. With the right team of language experts and translation tools in place, we were able to provide high-quality, certified translations.

2. Based on the final translation, the client was approved for Phase 3 clinical study by the FDA.

3. By utilizing a team approach and working closely with the client’s team, all clinical translation deliverables were delivered on time for FDA approval.