What turned out to be the most helpful of our technology solution for Cara however, was the customized proprietary clinical trial-centric production system.
Through this system, Cara and the CRO defined study-specific workflows, tracked budget and spend, measured turnaround times as well as other KPIs, and managed study contacts or roles. This was also the place where they stored study requirements, instructions, and all trial-specific information to be used for final compliance checks. Additionally, the system stored all study materials for easy search and retrieval of documents, providing full management of protocol titles in all languages.
Based on the individual request, each document submitted for translation was analyzed by the system against the original scope of work and thus identified as either in or out of scope. The latter case initiated a routine for Cara’s extra approval for out-of-scope work.
Acolad’s study production system allowed the team to manage timelines and ensure compliance with the agreed service level agreement and KPIs, compiled into regular reports.
Certified Processes and Dedicated Resources
Acolad’s ISO (ISO 9001:2015 and ISO 17100) certified processes ensured best quality from the start – including robust quality and risk management processes, but also the on-boarding of a dedicated team of specialized translators with strong clinical expertise – a crucial quality factor: We onboard only the most qualified linguists, monitoring the quality of their translations on an ongoing basis.
An Agile Dedicated Team for Fluid Collaboration
Our dedicated project management team also contributed extensive experience in the clinical study space, especially for Patient Reported Outcomes and linguistic validation – which were a part of the study.
We developed an agile and flexible work environment, allowing all study stakeholders to integrate easily with the collaboration environment required for clinical trials; the direct collaboration with Cara’s CRO streamlined receipt and transfer of study material, closely coordinating timing and schedule. The Acolad Account Manager also established a solid working relationship directly with Cara study managers. Thus, communication flowed easily between the three parties: Cara, the CRO, and Acolad.
