July 6th, 2020, by Labtoo's team
A contract research organization (CRO) is a company specialized in carrying out R&D services for pharma or biotech companies. The proposed services cover all R&D phases, ranging from preclinical research (toxicology, pharmacology, etc.) to clinical research, including strategy and marketing consulting.
Lately, biotechnology companies tend to outsource their R&D projects and thus have included the use of services providers into their business model for several reasons. On the one hand, biotech companies have often limited financial resources as well as they do not have systematically the technological resources to perform all their projects in-house. Time is also a critical issue in the survival of a small company. Relaying steps of your studies to a specialized R&D services provider able to rapidly achieve a project could be therefore a wise choice.
On the other hand, pharmaceutical industries are increasingly outsourcing their R&D in order to reduce drug development costs. Consequently, the market of services providers in the field of pharmaceutical and biotech R&D has been booming in recent years.
When looking for a CRO, you have several choices: generalist or specialized CRO, small or large structure, well-known or not... While a large CRO recognized internationally instills confidence and allows more flexibility, small and medium-sized CROs in France or Europe offer a tailor-made and highly specialized service (cancerology, neurology, cardiology, etc.) which may be more relevant to your project. Moreover, size and quality are not always correlated. Contact and discuss with several types of structures. In doing so, you will be able to compare prices, techniques and equipment used, to evaluate the scientific expertise and thus to choose the provider that will best suit your project. A network of CROs may also be a good solution to help you in your choice.
Even if a low price is an important criterion, it should not be the major one. Do not hesitate to compare quotes and to browse through the catalogue of biotech services that your services provider can furnish. If a services provider seems more relevant and more competent, although more expensive, it may be worthwhile to concede to a more substantial investment, which may protect you from additional costs (due to deadlines issues, or even a change of services provider during the study).
Delays in the preclinical phases can be extremely damaging to small structures and may even jeopardize their survival. Therefore, your R&D provider must be a trusted partner. When presenting the project, he must be critical about the provided elements and challenge the protocol that you are submitting to him. Good advices will save you time (and sometimes even money!). Your biotech provider should be clear and realistic about the time frame and the risks involved. Anticipation and reactivity are key elements that must be considered and evaluated when choosing a CRO.
Although being a young company does not mean lacking skills and seriousness, you may evaluate the relevance of the company and its biotech expertise through its experience. How long has the company been in existence? How many projects like yours has it already completed? Has their study model been approved and proven? The answers to these questions are valuable in evaluating your R&D provider.
It is also very important to know whether the company is compliant with current regulatory standards and follows the Good Laboratory Practice (GLP), that is required to develop a medicine.
Finally, it is essential that your biotech provider has a strong quality assurance policy and can provide you clear and detailed study reports. Assessing the quality of the service is essential, especially when it comes to preclinical studies that will be included in the market access authorization file for a drug.
To rightfully choose your services provider, it is essential to compare several companies. This will guide you towards the type of structures and expertises that will best suit your project. Give importance to prices but not at the expense of service quality. Make sure that health regulations are respected and that there is a strong quality assurance policy. Human aspect is a key criterion: communication and advice are qualities to be sought.