It is inevitable that research and development studies will face adversity and problems that must be addressed. However, the resolution and path to completion are determined by the framework used for each study. Finding the right balance between legal and compliance considerations can set a course on the best way to allocate resources for the most efficient completion. If you have not identified the frameworks (legal vs compliance) for your study, now is the time to do it. The way problems are handled will affect study budget and completion time. Legal and compliance frameworks do overlap, but they are not the same. For study purposes, they are distinguished as follows: Legal deals with laws and acts which must be adhered to by all parties involved. Compliance is adhering to an agreed upon policy between the parties. These differ from laws and acts because they are not mandated by authority but are obligations for contract fulfillment.
Understanding the importance of legal vs compliance in drug development studies helps define the paths to establishing and maintaining efficient budgets and timelines. For example, regulatory acts that affect these frameworks are: Drug Law, Informed Consent Laws, the Good Laboratory Practices (GLP), the Controlled Substance Act (CSA), the Federal Food Drug & Cosmetic Act (FDCA), etc. All of these provide rules and guidelines that provide structure. Having a solid idea of which applies to your study and limits applied revenue enables you to allocate resources accordingly. Understanding legal frameworks also adds a layer of protection to the intellectual property of the pharmaceutical companies. By understanding which framework is applicable your business can make choices that protect those assets. With knowledge of laws and acts that apply, you will be able to better assess the value of having legal counsel present. This can save in day to day study costs, as well as avoid unnecessary litigation fees.
While legal and compliance are distinct from one another, they have elements that overlap. Thus, pharmaceutical toxicologists must consider both in order to develop solutions that are the best fit for their unique study and needs. As pharmaceutical companies work to stay competitive in the growing marketplace, strategic resource allocation becomes critical to maintain budgets and timeframes. Technology has made drug discovery and toxicity studies more efficient than before. Technological advancements enable studies to be completed with reduced overhead. The same cannot be said about the legal compliance landscape. It is continually changing. New laws, acts, and regulations are constantly appearing, making it difficult to stay up to date. This makes having someone on your team who is aware of changes particularly valuable. Having someone who can identify the changing climate and adapt to it is essential to achieving goals and maintaining budgets. Studies are often started under one act or law, but before completion new laws may appear. This creates a shift in the paradigm during the study. Although the study was started under one act or law, new developments in the legal realm may bring up questions or challenges that must be addressed. Not knowing which framework to follow or how to respond to the issues raised can extend studies over budget and time. Being prepared in advance can mitigate any potential delays or extra costs.