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Literature Searches for CER Compliance

 

INDUSTRY

Medical Device
Pharmaceutical
Consumer Products

SERVICES

Medical Writing

SKILLS

Clinical Evaluation Reporting
Seven product-specific and two State-of-the-Art Extended Literature Searches completed.

The Challenge

A multinational corporation focused on developing medical devices, pharmaceuticals, and consumer-packaged goods was facing an impending deadline for Clinical Evaluation Report (CER) compliance. They sought a partner that had the nuanced capabilities and expertise to provide CER services. The first phase of the project included seven product-specific Extended Literature Searches and two State-of-the-Art (SOA) Extended Literature Searches utilizing the client’s search tool. The client was dealing with several challenges including limited team resources, a lack of technical knowledge, and budgetary concerns. Due to our long-term partnership with the client and industry knowledge in this area, Oxford Global Resources was able to take the time to fully understand the client’s challenges and devise the right solution.

The Solution

Oxford developed a creative, cost-effective model to take on the workload by providing a team of medical writing professionals. Our team developed a project schedule outlining estimated completion dates for all literature searches within the eight-month duration of the project.

Deliverables included:

  • Project schedule
  • Appraisals and analyses for seven product-specific and two State-of-the-Art Extended Literature Searches
  • Monthly status reports that identify accomplishments, next steps, and key issues and risks

Oxford provided a Senior Medical Writer/PM, SME, QC Specialist, Engagement Manager, and two Medical Writers to support the project.

The Result

Within the client’s specified time frame, Oxford’s experts completed the necessary product-specific and State-of-the-Art Literature Searches. The client was particularly impressed with the knowledge and abilities of our SME and dedicated technical resources. One Oxford consultant continues to support this client with their ongoing initiatives in this area.