Why Outsourcing QC of Regulatory and Medical Writing Documents is a Competitive Advantage for Large Pharma Companies

When considering outsourcing Quality Control (QC) tasks within the Regulatory and Medical Writing space, an evaluation has to be made of the benefits versus the potential risks of doing so. Managing QC activities or having a dedicated QC team alongside existing medical writing or other teams is no small task.

The additional workload of QC on top of medical writing activities frequently has been known to divert precious medical writer time and reduces productivity that can be better used for more complex and technically demanding activities.

Outsourcing Quality Control: A Strategic Move

Pharmaceutical companies across the world ask CROs like MMS to provide QC as a service for clinical documents that are prepared internally. Outsourcing QC tasks to a service provider brings considerable advantages, as detailed below.

Cost-effective

Many Sponsors choose to outsource their QC to reduce costs. Running an in‑house QC function involves high fixed costs, such as establishing infrastructure, maintaining equipment and technology, and significant investments in hiring and training personnel.

Outsourcing QC eliminates these expenses, allowing Sponsors to access high‑quality QC services without the associated overhead costs. Having a dedicated outsourced QC team also allows Sponsors to concentrate their resources and efforts on core business activities, thereby enhancing productivity and efficiency.

Scalability and Flexibility

A key advantage of outsourcing document QC activities is that it can offer scalability and flexibility in resourcing. Sponsors can adjust the level of QC support based on their workload and project requirements without the need for the expansion of their internal QC team.

This flexibility ensures efficient resource allocation, particularly during peak periods or when specific projects require additional QC capacity.

Faster Turnaround

QC processes can be time-consuming, especially for large and complex documents. Outsourcing QC can help to streamline the medical writing process and reduce turnaround times. This can be particularly important for regulatory submissions, where timelines are often tight.

Domain Expertise

Choosing an outsourcing vendor that specializes in the process or service you want them to carry out can help you achieve a more productive, efficient service, often of greater quality.

Outsourcing QC of medical writing to a specialized CRO partner can provide access to a team of experts who have extensive experience in performing QC of medical writing documents, have expertise in a vast range of therapeutic areas, and are familiar with regulatory guidelines, medical writing standards, and best practices. It is their job to stay up-to-date on the latest industry developments such as regulatory changes and testing techniques, as well as constantly innovating and investing in new technology and methodologies to ensure product quality.

This frees up pharmaceutical companies to focus on their own core areas of development.

Competitive Advantage

Outsourcing can help Sponsors leverage external knowledge and skills, and it can also help to make the Sponsor organization more flexible and agile, helping to better adapt to changing market conditions and challenges while providing cost savings and service level improvements.

Outsourcing QC to specialized CRO providers ensures that documents meet the necessary regulatory standards and guidelines. QC providers are well-versed in regulatory expectations, minimizing the risk of non-compliance and helping to avoid costly delays or rejections of submissions due to QC issues.

Hiring a CRO like MMS to outsource your QC needs has the potential to make your work life easier as the operation becomes simpler for in-house employees. Delegating work to an identified CRO can help your team focus on their responsibilities, which will increase productivity and efficiency. The combined benefits of the expertise, reduced costs and turnaround times, and flexibility that come with outsourcing to a global QC team can help to improve the efficiency and quality of the medical writing process and ultimately contribute to the development of safe and effective therapies for patients.

Tap into the expertise of an outsourced QC service provider; MMS has a team of trained and experienced people ready to QC your documents and meet your needs. Message us here.

Authored by: Naveen Kumar, Senior Manager, Quality Control, Regulatory and Medical Writing