In recent years, the role preclinical contract research organizations (CROs) play has been evolving. Traditionally, CROs would provide study data reports for well-defined projects. Now however, they are a more intrinsic part of the drug development process for many companies by providing strategic support and guidance to help ensure the successful progression of compound.
This shift has partly been driven by the focus on biologics, which require more complex testing than chemical entities. As such, preclinical CROs have evolved into centers where academic excellence and industry expertise are combined, meaning they have the knowledge and experience needed to proactively spot and solve challenges, providing their customers with recommended solutions.
However, not all CROs are the same so it’s important to choose the right organization for you and your compound. After all, it can be the difference between securing regulatory approvals or suffering delays.
So, how can you ensure that you choose the right preclinical CRO to help conquer the drug development process? Here we outline some of the key factors you should consider when making this significant decision.1. Make sure the preclinical contract research organization (CRO) truly understands your goals and challenges
Taking a molecule through to IND/CTA submission is a complex and difficult process and the success of your preclinical testing program can make or break your chances of attracting a co-development partner or out-licensing your product.
With these goals in mind and critical deadlines to meet, it's crucial to have a clear development roadmap for your compound. Therefore, when approaching potential CROs, make sure they can offer a clear project plan for your drug and can demonstrate in full what your preclinical program will involve, including costs and timings for milestones. Ultimately, this will not only highlight if they have the capacity to meet your needs, but it will also help to ensure that any issues are uncovered early on, before they have chance to derail your timeline.
It’s also imperative that you are given regular status updates, so that you can effectively manage the expectations of your colleagues and complete your own reports. From a preclinical CRO, you should expect nothing less than crystal clear communication, regular updates on progress, open and honest discussions around any issues detected, and recommendations about the most appropriate course of action. Essentially, you should look for a CRO that has the mechanisms in place to become an effective and seamless extension of your team.
Although project plans and effective communication significantly reduce the chances of coming up against unexpected costs, the complexities of preclinical drug development do mean that changes to your program may have to be made in real-time. Unfortunately, this can result in additional costs and even missed milestones, so we recommend that you engage with a CRO that has the experience to highlight and manage these risks before your program begins (meaning you can minimize the chances of any nasty surprises further into preclinical testing).
2. Work with a CRO with a history of success in preclinical drug development
In preclinical drug development, there is no substitute for experience. From adopting the most efficient development timelines and cost-effective methods, through to mitigating risks and overcoming unexpected technical challenges, working with a CRO that has decades of experience in delivering successful preclinical programs is the best possible way to ensure success.
One of the biggest advantages of working with a partner with many years of experience is that they’ll be better placed to execute your project in the shortest possible timeframe. For example, a CRO that has been running preclinical programs for decades will have learned through practice what it takes to design optimized studies that make the most efficient use of lead-in time and resources to deliver results on time and on budget. They’ll also know the best strategies to de-risk programs as early as possible in development to improve decision-making.
Of course, even with the best laid plans, unexpected challenges can and do arise; what counts is being able to adapt and overcome them. This requires access to both regulatory experts and internationally renowned specialists across a broad range of fields who can bring knowledge and learnings from a wealth of relevant projects to solve problems faster. By choosing a preclinical CRO with strong regulatory expertise, you can be sure that the fastest development path will be identified for your compound, as they know which data is needed to satisfy regulations. Therefore, look for a CRO whose key scientists and regulatory experts have been in the industry for decades and have experience across an array of drug types and therapeutic areas.
3. When choosing a preclinical CRO, consider regulatory policies and procedures
Before outsourcing any aspect of drug development, it’s important to make sure that your preclinical CRO is fully compliant with all applicable regulatory requirements and local legislations – and can prove they’ve got the processes and people in place to support this.
It almost goes without saying that any non-clinical laboratory studies that are undertaken must be Good Laboratory Practice (GLP) and ISO 17025-compliant. So, ask your prospective CRO how they assure the quality, integrity and consistency of any relevant work they plan to undertake. You’ll also want to make sure that any production work carried out is compliant with Good Manufacturing Practice (GMP) and ISO 9001 requirements.
This isn’t simply about ensuring they have robust testing protocols in place, it’s about putting quality at the heart of every product design decision and minimizing the risk of poor-quality outcomes in the first place. By bringing together effective study design, optimized processes, and experienced, knowledgeable experts, it’s possible to deliver consistent, quality data packages that not just meet, but also exceed the required standards every time.
For this reason, our team at Envigo has established a risk-based quality management system that assures full compliance with all relevant regulations. All of our regulatory studies are conducted in accordance with applicable local legislation and we inform monitoring authorities of any relevant changes to working practices, as required by the respective quality regulations.
Another key aspect to discuss with the CRO is animal welfare. We recommend asking the preclinical CRO how they support animal research and where they stand on the 3Rs – refinement, reduction and replacement. Ideally, they should closely follow recommendations published by recognized animal care organizations and legislative bodies. For example, here at Envigo, we strongly align our animal welfare and quality programs with guidance from the AAALAC, ISO, IACUC, OLAW, USDA, AWERB, ASPA and PHS.
4. Choose a preclinical CRO that puts communication and collaboration at the core of every program
Effective two-way communication is important in any partnership, but when projects involve as many moving parts as preclinical drug development, it’s crucial. From scientists at the bench right through to study directors and program sponsors, there’s a lot of information that must be shared with the right people, at the right time. Poor communication, wherever it happens in this value chain, can cause timelines to slip, costs to spiral and whole projects to be postponed, repeated, or even canceled.
A preclinical CRO that provides you with regular updates is one thing, but it’s also important that information flows freely within the organization’s own internal teams.
For this reason, it’s important to choose a preclinical CRO that adopts a fully integrated approach to drug development by connecting scientific, regulatory and project management experts to form seamless teams. Organizations that enable these teams to work together to solve problems help ensure that decisions are made with all of the relevant stakeholders at the table. This allows them to work more efficiently, make better decisions and overcome unexpected challenges more easily.
Planning a preclinical drug development program?
Outsourcing part or all of your drug candidate’s preclinical development using an experienced and trusted preclinical CRO can be one of the best ways to increase your likelihood of success and establishing an effective CRO partnership is critical to this. Read our article on how to get the most out of your CRO.