Outsourcing translations for multilingual adverse event reporting compliance

As a manufacturer of pharmaceutical products, including drugs that many of us are familiar with, our client shoulders a great deal of responsibility in keeping consumers safe.

As part of post-marketing safety surveillance programs for drug and therapeutic biologic products, they must record adverse events into a proprietary system in order to ascertain patient safety, risk management and product improvement. These events are observed by clinicians in Canada and reported in French.

However, the reports require translation into English within two hours to remain compliant with the health authorities. This proved to be a demanding task for the client’s small internal team, who needed the freedom to maintain focus on drug safety.

They therefore decided to outsource the translation step of the overall reporting process.

Due to the strategic importance for timely, agile and accurate reporting of adverse events to the health authorities, our client needed a partner who could:

• Understand the critical nature of adverse event reporting
• Ensure linguists would be available throughout the entire business day
• Guarantee the expertise and experience of the linguists within the specific therapeutic area
• Allocate enough resources to complete the translations within the allotted two-hour turnaround time

Acolad was chosen as the translation partner. The key to the success of the partnership was to fully integrate Acolad linguists into the client’s existing customized workflow to meet their business and regulatory requirements.

A continuous shift of linguistic and project coordinator resources was established and managed to ensure any adverse event report submitted is translated within the allotted two-hour turnaround time.

Since the beginning of the partnership, Acolad has been responsible for managing the volume and capacity requirements.

• Complete business continuity between internally managed processes to outsourced localization services model 
• Uninterrupted workflow with accuracy and agility 
• Client internal Drug Safety teams are now free to focus on other priorities 
• Continued compliance with strict regulatory timeframes