The client had one year to complete a huge number of backlog studies in order to adhere to internal policy.
Kinapse was chosen to work with two of the client’s alliance partners (APs).The APs could not handle all the disclosure assignments themselves, so we were approached to take up the urgent requests.
To clear the backlog studies within the desired time-frame, an FTE model was suggested and implemented.
We assigned an India-based, dedicated team of 11 FTEs, to ensure the knowledge of processes and systems was maintained and shared. Within six months we transitioned to a purely India-based team to reduce costs.
We were able to accommodate the work requests which had been pulled from the APs and delivered excellent quality deliverables.
The client has remained a long-term partner with Kinapse since June 2010. In that time, we’ve worked on more than 500 results postings for ClinicalTrials.gov.
We’ve delivered consistent and measureable quality that has exceeded expectations. More than 70% of the studies we have completed have been released without NIH QA comments.
We cleared the initial backlog of studies on time. Based on the expert service we provided over 4 years, the work contract was extended to cover around 200 studies for upcoming EU disclosure requirements and CSR redaction.