Background

“A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must, on average, manage a whopping 1250 SOPs with the average maintenance burden at 15,000 hours.” Tim Brennan, Technical Writing 101 for Biotech and Pharma Companies. That means that a team of 7 people, working full time, would be merely updating existing SOPs (Standard Operating Procedures). This addresses new or changing laws, regulations, or compliance standards not to mention process or technology improvements and mistake proofing.

Client Need

To move a new product from development to market and gain FDA approval, a small bio-med firm determined that at least twelve new SOP’s would be required. These SOP’s ranged in complexity but would require the expertise and full attention of their four-person in-house technical writing team for 2-3 months.

EDC Solution

Essential Data provided four writers to backfill the internal technical writing team to temporarily take over and maintain the existing SOP maintenance workflow. The first group of two remote writers were trained by one of the company’s internal writers. This allowed three of the company’s technical writers to focus immediately on the new product documentation. After two weeks, the second team of two remote writers joined and were trained by their Essential Data teammates. This freed up the remaining company writer and allowed the entire in-house technical writing team to focus their expertise and effort on the new product SOP’s and related documentation.

Benefits for the Client

With the help of Essential Data’s top-notch technical writers, the BioMed firm was able to:
  • Focus in-house talent and expertise to address critical needs.
  • Manage project costs and timelines more effectively using inhouse expertise.
  • Maintain head count and long-term staffing objectives.
  • Successfully bring their product to market while maintaining company operations and financial objectives.

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