Relax! – There’s a Solution to Your Document QC Dilemmas

In recent posts, we discussed how using internal employees to QC key documents is not cost-effective, or efficient, and may reduce the quality of both the QC document, and other high value activities your employees are engaged in. Today’s post illustrates how outsourcing to a professional Document Quality Control Team can enhance your QC experience by making more efficient use of resources, improving document quality, and ensuring that document delivery is not rate-limiting to your product development program.  

Finalizing study reports, or preparing submissions, are not daily tasks in most companies or business units. The demand for QC services is sporadic, with peaks and valleys depending on the volume of documents needing review. Using an outsourced Document QC Team eliminates the need to maintain dedicated staff, or risk distracting employees from other high value activities while they take on the extra work. A Document QC Team is flexible and scalable to respond to fluctuations in demand, allowing more efficient staff utilization. Cost efficiency is also improved since clients only pay for the actual hours spent in reviewing documents, without the associated costs of employee overhead.

In the life sciences field, Document QC Teams need to possess an in-depth understanding of many different therapeutic areas, as well as extensive experience in the QC work that goes along with the documents these areas generate. Attention to detail and clear communication must be among the highest priority.

Hiring trusted experts in the field, with over ten years of experience, who have reviewed several thousand documents for multiple Fortune 500 companies, provides clients with peace of mind, flexibility, scalability, and vast improvement in the quality of the document review.

With a reliable and reproducible process to deliver high quality QC results 100% on time, or early, with a benchmark of 50-75 pages per day on average, a Document QC Team allows the client to focus on the next steps of the process. It also ensures that internal employees can focus on what’s most important in their jobs. It’s highly unlikely that internal personnel can deliver the same quality, along with other daily responsibilities and still meet tight deadlines. A Document QC Team must have the client’s back and be 110% dedicated to reviewing their documents in a timely manner. Clear communication and defining expectations up front, before the project is started, is paramount.

The risks involved in handing QC in house can be quite painful, often resulting in delayed CSR preparations, along with the sponsor’s loss of considerable revenue for each day that the marketing application’s approval is delayed. Mistakes can cause the reader to question the validity of the content and may lead to errors in interpretation. A good QC review takes time, but is well worth the effort.  

Probably the most important factor in outsourcing is that while this task/requirement may be sporadic for your organization, an outsourced team is continuously working this process and are constantly perfecting and improving!

There should be a vested interest realizing that in our line of work, it’s a race against time to help real lives that depend on us collectively to meet deadlines, and facilitate the process of getting life-saving drugs to market.

If you would like to learn more about DataCeutics’ Quality Control Services, or discuss your own Documentation Quality Control needs, please reach out to Jeanne Lane lanej@dataceutics.com or Kathy Greer greerk@dataceutics.com

Let us Show you How DataCeutics can Help!