Pharmaceutical companies are paying more attention to value than ever before. With budget cutbacks and mergers and acquisition “synergies,” companies are forced to restructure resources and invest in the intangibles such as quality, responsiveness, flexibility and real-time reporting. There’s also a push to develop innovative, quality medicines to support accelerated drug development programs. To meet this demand of doing more with less, many pharma companies are shifting towards outsourcing as part of their business model.

Preclinical and clinical outsourcing is a growing trend in the pharmaceutical industry, no matter the size of the company. As a result, Contract Laboratory Organizations (CLOs) and Clinical Research Organizations (CROs) are quickly growing, which makes it even harder for pharma companies to track and manage work outsourced across multiple organizations.

Preclinical and clinical testing was once conducted within the same four walls of the company marketing the product. Now it’s more often outsourced to contracted researchers all over the world and conducted in different ways. Today, when a sponsor company decides to outsource research, it gives up control on how the testing results are being recorded. The collected data could be stored in an Excel document, or just written in a notebook, for example.

For a long time, North American pharma companies have had an advantage when it came to outsourcing preclinical and clinical work because of relative economic stability, scientific experience and proximity to the majority of the pharma industry. That advantage gave them a sense of reassurance knowing their outsourcing organizations were familiar with regulations and quality practices.

With more CLOs and CROs popping up in regions all over the world, more and more sponsor companies are drawn to the upfront cost savings from shipping research overseas. However, the travel required overseas to audit and qualify labs is time consuming. Once a lab is qualified, the sponsor company may have to tap all of its resources to ensure that proper procedures are being followed throughout the testing process.

The sponsor must then ensure that the provider’s data is dependable by confirming that uniformed processes are used to administer, document and manage change throughout all phases of testing, as per FDA regulations and its own requirements. Poor laboratory practices or inexperience in meeting required regulations are often the cause of data being thrown out. If not done correctly, the company outsourcing the work will be held accountable for any potential issues.

Whether it is small batch processing, correspondence or audits, it is critical that quality processes are managed throughout R&D in order to optimize time to market of a safe and effective drug.
 
The need for preclinical and clinical quality management technologies to help manage compliance and quality processes using a single, centralized system is imperative, whether outsourced or not.

Today’s leading pharma companies rely on enterprise quality management systems (EQMS) to manage the myriad of standard quality processes — both in-house and outsourced — such as audit, corrective and  preventive action (CAPA), deviation, and out of specification/out of trend (OOS/OOT). The technology is in place to streamline the oftentimes siloed quality processes of bringing a final product to market and create a holistic and transparent view of a company’s quality data.

With an EQMS, pharma companies can plan and execute audits to identify operational and compliance risks, like a trial not being administered the same way throughout the testing period, and help to ensure that findings are resolved in a timely and effective manner.

Taking a holistic approach to quality, pharma companies can automate CAPAs precipitated by deviations, complaints, audit findings and laboratory findings and manage the process of carrying out CAPA plans and verification of the plans’ effectiveness on a global scale.

Outsourcing organizations have their own processes, procedures and systems that may not translate into complete transparency that the sponsor would require should an issue arise. This could result in falsified documentation and lack of trust in believing these organizations are doing what they say they are doing.  Automating preclinical and clinical quality processes from A to Z can help sponsors trust the people they work with and provide evidence those proper procedures are being followed.

As contractors are held to the same FDA guidelines and requirements as their pharma sponsors, having an EQMS can ensure issues such as deviations, OOS/OOT and complaints are properly and efficiently investigated and brought to resolution through the tracking and managing of the initial report, phased investigation, root cause analysis and any resulting CAPAs and controlled changes, fully closing the quality loop.

Many CAPA processes end with requiring changes to trial criteria, documentation, or additional critical areas of the trial or product manufacturing.  Most of these changes require a formal change control process. Some work could be spread out among several organizations, making it harder to confirm the trials are conducted in uniformity from the products being used to how the trial is being conducted. Managing these changes is critical, because any change can impact the results of the trial or consistency of the product being tested resulting in a deferred time to market.  Having change control as part of an enterprise quality system closes the loop from event discovery, through the investigation to any CAPAs and changes made.

Sponsors are ultimately responsible for ensuring all regulations are followed and that the brand and label are a clear representation of what that product intends to treat. When a pharma company gives up any control to contract service providers, it may gain increased flexibility and capital, but if not done correctly, it could become very costly. An enterprise quality management system ensures quality processes are systematically managed throughout drug R&D in order to optimize time to market as well as comply with regulatory requirements.