It has been said that drug companies produce two major products, the drug and all of the documentation required to support its development, regulatory approval, and commercialization. The Tufts Center for the Study of Drug Development estimates the cost to develop and bring a drug to market at $2.7 billion. Documentation is a big part of this cost, making up as much as 25%. In the current cost-cutting landscape, it is very challenging to deliver the required documents on time, and with the desired quality. Managing documentation, especially the Quality Control (QC) piece, may be best handled by an outside firm for several reasons, in addition to keeping costs down.
Managing all of the documentation, particularly QC, presents major challenges for companies:
The quality control (QC) workload does not have a steady, or predictable flow, because the demand for it may be sporadic due to reworks, or delays upstream to the QC review process, as documents are being finalized. This makes staffing and scalability difficult for companies. As we all know in today’s world, companies strive to do more with less, and it’s often not possible to reserve staff positions to do QC specifically, so when needs arise, employees are often asked to take on this huge responsibility in addition to their regular jobs.
Using internal employees for this QC function, often has a broad negative impact. As workers are taken away from their daily responsibilities, they can be distracted and likely not able to focus 100% of their workday on the QC, slowing down the process, and resulting in a longer lead time for QC completion. Furthermore, internal staff are often too close to the data, creating the potential for bias, or for inadvertently overlooking errors.
Some Considerations That Can Ensure Your QC is Strong:
Ensure you have resources in place that can respond to the peaks and valleys in the QC workload.
Look to outsource the function where you may have an option for hourly work, so you don’t have to pay for the overhead of a full time employee.
Ensure you have a reliable and reproducible process to deliver high quality QC results 100% on time or early. A good benchmark is QCing an average of 50-75 pages per day.
Try to avoid using internal employees. It’s unlikely that an internal person can complete this function, along with other daily responsibilities, and meet tight deadlines.
Delayed CSR preparation can result in the sponsor’s loss of considerable revenue each day the marketing application approval is delayed. Mistakes can cause the regulatory 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. Real lives depend on us collectively to meet deadlines and to facilitate the process of getting life-saving drugs to market.
Looking to Outsource Your Quality Control Needs?
Documents requiring QC reviews include: Clinical Study Reports (CSR), CSR Synopsis, CSR Addendums, Summary of Clinical Safety (SCS) Reports, Safety Update Reports, Summary of Clinical Efficacy (SCE) Reports, Clinical Overviews (CO), and more.
Choose a company that has an in-depth understanding of many different therapeutic areas, and the reports generated for submissions, as well as extensive experience in the QC work that is required.
Select a company that has reviewed several thousand documents over the course of 10+ years for multiple Fortune 500 companies. They should offer flexibility, scalability, and quality improvement during the document review process.