Why Using Internal Resources for Document QC is Inefficient

In a recent post, Easing the Pain – Outsourcing Document Quality Control Efforts, we talked about the advantages of outsourcing, and the disadvantages of using internal resources to QC key documents. We highlighted how assigning QC tasks to salaried employees with full-time workloads can impact quality, distract staff from other critical tasks and add to workplace stress. We also touched upon the added cost and additional time involved in using internal resources. Let’s explore the cost and inefficiency factors more thoroughly here.

What document QC is costing you

Do you realize how costly it is to have fully loaded employees perform your document QC?  Full-time employees have additional costs beyond their salary including benefits, taxes, 401K contributions and infrastructure costs.

For example, the fully loaded cost rate for an employee (basic salary + employment taxes + benefits) is typically 1.25 to 1.4 times the base salary. For example, a base salary of $175,000 might be $218,750 to $245,000 after taxes and benefits. Benefits may include life insurance, health coverage, long term disability insurance, dental plans, dependent care assistance, tuition reimbursement, retirement plans, etc. Vacation and sick time are usually subsumed in the basic salary.

In an earlier blog, we pointed out that QC work requirements have peaks and valleys of demand, making it difficult for a full-time employee to fit the needs of the position.  A functional service provider, on the other hand, can offer resources on an hourly rate, saving a significant amount of money.

Let’s look at the example of a 150-page Clinical Study Report (CSR) and assume the QC takes 4 days @ 8 hours/day to complete. If a functional service provider performs the QC at $100/hour and an internal employee performs the same QC, the hourly rate (loaded) could be up to $105 – $118/hour based on the loaded calculation above. Total cost for an internal resource to perform the document QC is $3,360 - $3,776 compared to only $3,200 for the functional service provider. If we multiply these savings by the multitude of reports that most companies need QC’d annually, the savings is considerable. Keep in mind that these calculations don’t even account for moneys lost due to increased job stress, quality concerns and delays associated with the use of internal resources.

Why using internal resources is inefficient

In addition to cost concerns, we also raised the issue of internal resources being inefficient because full-time employees are not able to maximize their time when asked to perform document QC checks. Let’s examine that in more detail.  

Typically, a QC workload does not have a steady or predictable flow. This sporadic demand for QC is due to the fact that CSRs, NDA and other submissions do not occur every day, and also due to reworks or delays upstream to the QC process. Since it is not cost-effective to reserve staff positions to do QC exclusively, when needs arise, employees are often asked to take on this responsibility, in addition to their usual workload and daily routine. As a result, internal employees try to squeeze the QC of documents in between meetings and other responsibilities. Because of this inefficiency of workflow, there is most likely a much longer lead time to QC completion, compared to that of a dedicated outsourced functional service provider.

Let’s use the 150-page CSR from the example above. The dedicated functional service provider could complete the QC in approximately four days. Compare that with the internal employee, who may take up to ten days to complete the QC due to the additional responsibilities and inherent distractions.

One of the biggest advantages to outsourcing your QC is maintaining objectivity. Internal employees often prove to be too close to the process and have potential for bias, or for inadvertently overlooking errors. Engaging your employees in the adjudication process, rather than in the initial QC review, can maximize the efficiency of the document QC process extensively.

How outsourcing document QC efforts can benefit you

Outsourcing is quickly becoming one of the most utilized business practices in today’s challenging economy and has saved many businesses from failure by cutting costs, improving revenue and boosting operations. By outsourcing document QC, you can save time and costs by allowing your employees to continue their day-to-day activities, while document QC is completed by highly experienced, dedicated professionals in an efficient and timely manner. Choosing the right functional service provider, with the highest level of expertise, will give you the reliability and confidence you need to deliver high quality QC results, allowing your employees to make the best use of their time in review and adjudicating of the QC findings.

Where you can turn to for help

Stay tuned for our next publication “Let Us Show you how DataCeutics can Help.”

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