The legal function plays a major role in the drug development process, especially when it comes to partnering with an outsourcing provider. Legal documentation is commonly put in place between sponsor companies and outsourcing vendors to protect all parties who are entering into an agreement, to ensure that deliverables are achieved. From confidentiality agreements (CDAs) to master service agreements (MSA), these important documents, among others, are necessary to kick off project discussions and to agree on the scope of work that will be conducted on a program. The process of putting documentation in place is standard to any drug development program, however, each company can have its own approach which can make the process lengthy and cumbersome.
At Quotient Sciences, we have our own unique philosophy when it comes to the legal aspects of working with our customers and their programs. Our in-house legal team supports our colleagues and our customers by being helpful, responsive, and jargon-free. They understand that the overall goal is to develop products and deliver clinical trials in a safe and timely manner, so they do their very best to truly support Quotient Sciences' mission of molecule to cure, fast.
Streamlining the project kick-off
Having alignment with the customer is key when trying to start a development program. By taking a modular contracting approach, we ensure that our legal processes are fully aligned with the customer’s own journey for their molecule. This allows customers to do business based on the stage of development or services that they need at that time.
For example, if a customer needs formulation development and clinical manufacturing support but may not be ready to begin clinical testing for their program, they can contract specifically for the services they need, then add a simple short module to the agreement later. This enables them to sign their clinical program when they are ready to do so, without lengthy or repetitive legal negotiations. Conversely, if the initial contract is for a clinical pharmacology study but later on the project develops a need for manufacturing support or evolves into an integrated Translational Pharmaceutics® program, it is a simple step to add on a short module to the existing agreement to facilitate this.
Protecting customers & the organization
At Quotient Sciences, our legal team helps protect all parties by having a clear delineation of risks and responsibilities, adherence to regulatory guidance, and a willingness to help customers from other countries navigate local complexities, such as UK or EU privacy rules. This collaborative approach helps protect our customers, our study volunteers, and our organization.
Benefits of close collaboration
In a business where time and speed are critical, every function, including legal, is focused on how they can streamline processes to get new medicines to patients faster. As their objective, our legal team works in close collaboration with our customers and is responsive to their needs. They are focused on removing the red tape and achieving our mutual goals of signing and starting projects in a safe and timely manner.
They deliver on this in three ways:
- Speed of response: we aim to review all project agreements in 1 week – allowing our customers to progress their projects quickly. No disappearing into a legal black hole here.
- Ease of understanding: our contract templates are designed to be easier to use and understand than most legal documents – for example in our last major update, compared to the prior version of our core template we removed 52% of paragraphs, 31% of the word count and made a 40% improvement on ease of reading on the Flesch scale
- Helpfulness of colleagues: our contract edits are intended to help reach a resolution – we provide comments with context and solutions where possible, not just endless rejections without any rationale. We’re also always happy to talk – no hiding in the background or endless emails, we’d rather pick up the phone to address any challenging topics.
Our legal approach is just one of the many ways that Quotient Sciences is focused on streamlining and accelerating the drug development process for our customers. Contact us to learn more about how we can help accelerate your program to its next milestone.