While TigerTox consultants are familiar with all aspects and process of toxicology studies, our experience shows that understanding legal requirements and options that affect how study contracts are structured and completed is a critical aspect of implementing plans to accomplish key strategic objectives. Often, requirements that are largely seen as focused on business strategy can directly inform business strategy. Understanding how these mutually reinforcing aspects of how drug development projects are planned and executed can make a significant difference in how well a project is planned and executed. One such key area is the understanding, and appropriate management of the nature of legal custody. Legal custody can have an important impact on how a toxicology study is set up and executed. Understanding how to leverage the sole legal custody michigan requirements to one’s advantage can be a significant competitive edge in planning and executing successful toxicological research.
Specifically, understanding that sole legal custody can have direct implications on how a toxicology study is planned and executed can have a direct impact on whether a project is executed according to a timetable or delayed. This is particularly important when a toxicology study is required from a specific lab in order to meet a specific deadline. Understanding that these requirements move past the realm of standard contract law and into the business of family law can be useful for ensuring that a toxicology study is completed on time.
One example of specifically how legal requirements can impact a drug development project is in the context of legal custody. For example, if an animal study program includes legally owned animals that will be raised by the company that commissioned the study, in order to ensure that no other party has rights to the animals, it may be advisable to structure the contract for the study so that no one (other than TigerTox) has sole legal custody of the animals. This can be critical, for example, when a toxicology study is delayed due to any reason involving the company that commissioned the study, if it is very important that no one else has legal custody over the animals. If the party involved in a toxicology study does not have sole legal custody over the animals, but rather shares legal custody of the animals with another party, this arguably leaves the door open for another party to argue that the study was compromised either due to having had the animals returned to the original owner of the animals, or releasing the animals into the custody of a third party with whom legal custody is shared. However, if the logical conclusion of the study is to destroy the animals in the course of research, or send them to be destroyed at another location, keeping animals secure from interference from any other party is critical for ensuring that the study proceeds without delay, and for ensuring that the final report will be admissible as evidence in court.
For more information on legal custody and its implications, you can visit Wikipedia.