Scientific Validity Reports

Discover how Oxford’s team of medical writers completed 150 scientific validity reports within five months.

INDUSTRY
Medical Device

SERVICES
Regulatory Affairs

SKILLS
Medical Writing

The Challenge
With over 150 Scientific Validity Reports (SVRs) pending, an incredibly short timeframe, and a lack of in-house resources, a midsized in vitro diagnostics company had a need for additional support. Due to Oxford Global Resources’ ability to provide resources with the in-demand skills needed for this initiative within a short timeframe, the client determined we were the right partner for the project.

The Solution
We provided a small team of medical writers with specific knowledge pertaining to IVD regulations and medical devices to provide assistance from a remote work environment. In order to maintain realistic timelines and cost estimation for the client, it was determined that each report would take no more than 16 hours to complete. To increase efficiency even further, all 150 reports were bundled into logical families so that they could be approached the right way.

The Result
The potential timeframe to complete these reports may have been several months, but with Oxford’s support, all 150 will be completed within just five months. At this time, over eighty percent of the initial 150 reports have been completed, and our team of medical writers continues to support this client.