When it comes to clinical research, certain necessary functions may be managed by an outsourced partner, such as a central laboratory or a contract research organisation.
As the drug discovery process is extremely complex and yields very low rates of actually usable and efficient drugs, costs have skyrocketed. One way to lower these costs is to outsource part of the process to a contract research organization (CRO). For instance, pre-clinical research, clinical research or pharmacovigilance of a new treatment can be outsourced to a CRO.
A CRO is a company that provides support to the pharmaceutical, biotechnology, and medical device industries by offering to outsource specific research services (such as pre-clinical research for instance). The point of hiring a CRO is to both alleviate costs of specific aspects of research (by avoiding the long-term costs of maintaining certain skills in-house) and to simplify the process by hiring professionals specialised in their area of expertise.
In this article, you will learn how to select the right CRO for your research.
What is pre-clinical research?
Pre-clinical research is a term covering all the comprehension of a pathology. It includes design tests, selection of the most adapted molecule(s) or medical treatment for it and other afferent issues.
Also, before even testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called “toxicity” and whether it will be effective, also called “effectiveness”. These studies must provide detailed information on drug safety data (dosing and toxicity levels), but also on feasibility (can we actually design and then mass-produce the drug with a desired effect?) and iterative testing (the first iterations of the drug, how it would be constructed and what would be in it).
The point of pre-clinical research is therefore to determine a starting safe dose for the first in-human studies down the line, as well as assessing potential toxicity, but also to understand the disease studies to integrate as much data as possible to build upon in later stages of the research. To do so, researchers have access to a wide array of pharmacology disciplines, such as pharmacodynamics (PD, understanding what the drug does to the body), pharmacokinetics (PK, understanding what the body does to the drug), ADME (absorption, distribution, metabolism, and excretion, or understanding the drug’s “life-cycle” in the body), and toxicology testing.
There are two types of pre-clinical research: In vitro and In vivo.
In vitro means “in the glass”, it refers to testing being done on cell cultures or tissue extracts (more accurately, it refers to tests being done “in glass apparatus” so in test tubes, beakers, etc. and not on whole organisms). Before putting animals or humans at risk, researchers can try their product out directly on cells in a controlled environment.
They can thus observe whether the drug will deteriorate cells or if it will have any other kind of adverse effect. It can also be used to test for positive effects.
In vivo means “with the living”, it refers to testing done on animals or more generally whole organisms such as plants (it can also mean testing on humans but not in the context of pre-clinical research, as the entire point is avoiding putting humans at risk by testing potentially dangerous drugs on them before knowing more about their effects).
Pre-clinical research is regulated (for instance by the European Union’s Good Laboratory Practices) when it comes to facilities, equipment, protocols, reports, etc. Which makes keeping this process in-house more trouble than it is worth for a lot of companies, who instead elect to use a specialised CRO for this part of the research. That being said, pre-clinical research is much less regulated than clinical trials (and for an obvious reason: pre-clinical research does not test substances on humans).
Pre-clinical research is a pivotal part of the drug development process, as it will determine whether the research can go ahead to human testing (and ultimately, to review by the authorities and market sale).
How to conduct pre-clinical research: Due diligence, high quality and Clinical Operations
This kind of research also always needs to ensure due diligence; which means the investigation or exercise of care that a reasonable business or person is normally expected to take before entering into an agreement or contract with another party or an act with a certain standard of care. It can have a legal framework (can mean the compliance with legal safety standards for instance).
In the same vein, it also has to ensure proper data management; a concept meaning the handling of data as a valuable resource. The stakeholders have to both organise and protect it accordingly.
Another important concept is high quality in pre-clinical research; meaning a satisfying standard when taking into account data integrity. Companies and organisations have developed systems to improve quality, such as: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action.
Why should you employ a CRO for your research?
Companies contracting out for pre-clinical research may or may not elect to use a CRO. But most of the time they do, since CROs may have skills of know-how the company may not (for instance, experience on how to submit a proper application to the relevant regulation authorities). CROs are also highly reactive, being specialised in outsourcing in their field. Additionally, they are a more efficient point of contact with exports
CROs can be big companies with a lot of funding. Comparatively, smaller CROs offer some advantages: they can be more flexible and with less points of contact, they are easier to integrate in a company’s program from a strategic and cultural perspective, they are also more accessible and affordable to smaller pharmaceutical companies who lack the larger budgets their bigger counterparts may enjoy. They can also be interesting to bigger pharmaceutical corporations depending on the services they specialise in and the budgets involved.
Unrelated to size, CROs can have more or less financial stability: it means their ability to balance their budget and face unforeseen events. It is yet another factor to take into account when choosing the right CRO. Also, you should always try to know the CRO team’s members. If not to get a sense of their experience and usual quality of work, then to directly talk with them about your expectations and what they can deliver, in their own terms.
Since internal and external teams can be working together on such complex projects, it means project managers in the CRO (sometimes with the client’s oversight) need to establish clear goals for each of the teams working on the project and make sure all those goals are ticked in order and in a timely fashion so the project’s final objectives can be reached on time. This is called project management and is all the more important when choosing to work with a CRO.
CROs can also offer more services than the ones asked for in the first place. That means instead of focusing on a specific aspect of pre-clinical research, depending on their expertise and experience, the CRO can offer additional manipulations that will garner more reliable data. While more expensive, it can increase the project’s success rates down the line.
Ultimately the 5 most important things to consider when choosing a CRO are:
– Does it provide the services the company is looking for?
Carefully consider which activities will be performed by who in your project and whether you have the means to perform them internally or if it is more interesting to have them performed externally.
– Does it have the right experience and/or expertise?
Considering the processes you wish to outsource, does this company have the expertise you seek and/or the experience they need performing them for you to consider them a reliable choice?
– How good is its client service?
There will be a lot of back and forth between the company and CRO, which means they both need to be reactive and dutiful; what is this company’s reputation?
– What level of quality is the company known for?
It may seem obvious, but it better not be left unchecked, always verify the track record of the companies you wish to hire.
– Do you have the budget for it?
As always, the bottom line is: can you afford it? Carefully consider which company offers a satisfactory quality of service considering your budget.