At TigerTox, we make no bones about it: it is our job to execute studies efficiently and effectively. It is an ethos that informs everything we do, from protocol development to final report issuance. Naturally, this focus on efficiency and effectiveness translates to other areas of toxicology as well. Today, we’re going to look at an often overlooked area of study execution: implementing a servicing agreement effectively. A quick primer to impart definition: a servicing agreement is a document that governs the terms and conditions by which one company (“Servicer”) provides goods or services to another company (“Recipient”). Servicing agreements are therefore broad in scope, and are used across industries. In the pharmaceutical industry – where we primarily operate – these agreements are often used to govern matters such as laboratory space and equipment usage within a CRO or research institute or study monitoring services provided to a specific laboratory or company. Servicing agreements are thus especially relevant to the pharmaceutical industry for their role in ensuring compliance with GCP and GLP. They also serve to ensure compliance with Federal regulations regarding the use of grants, contracts or cooperative agreements. In essence, servicing agreements further the strategic aims of drug developers by ensuring that the projects undertaken to bring a drug from conception to market are not derailed by costly compliance issues that can delay a project for months.
But why should one utilize a servicing agreement in drug development? For one, they can ultimately save time and money during the study execution phase of drug development. How? Consider for a moment that generally speaking, the more moving parts that comprise a research plan, the more potential for those moving parts to be misaligned. When a servicer has been contracted to provide goods or services to a recipient, the recipient is freed of the responsibility to ensure that each moving part is functioning in harmonious synergy a la a Rube Goldberg machine. Such contractually specified duties and responsibilities become the burden of the servicer instead. Take for example an animal study for a novel drug compound. A Servicer may be tasked with and specifically hired to conduct certain aspects of the toxicology study that are otherwise quite difficult for the drug developer to carry out. Without the contractual relationship, the drug developer would need to invest considerable time and effort figuring out how and where best to achieve compliance, allocate resources and tailor the toxicology study to achieve its aims. With the Servicer, however, the drug developer can focus time and resources on those areas where they are best suited.
The upshot? The allocation of resources is streamlined through a contracted relationship between the Servicer and Recipient. Time is saved on project execution and compliance concerns. The toxicology study can be better executed by focusing resources on the important aspects of the toxicology study. Ultimately, this leads to faster project completion and quicker time to market, which can only serve to enhance your bottom line.
For more information on compliance in drug development, you can visit the FDA’s website.