A contract research organization (CRO) provides research services on contract basis to biotech, pharma and medical device industries as well as academic institutions.
Whether they function as full service CROs or offer a special selection of services: They are important partners for many pharmaceutical companies and help to shape life sciences and the healthcare sector, e. g. with support in the development process of vaccines, medications in oncology, for rare diseases and other therapeutic areas.
This post will highlight the core activities as well as Pros and Cons of a CRO, how to avoid the potential pitfalls of unreliable CROs, and point out how your organization can benefit from outsourcing to recombinant antibody expression service providers like evitria. But first, let’s discuss the question: What is a CRO?
Contract research organizations (CROs) offer their technical expertise and experimental support to other companies or public agencies on contract basis. They specialize in tasks which require vast amounts of focused expertise and specific equipment, one example being antibody production services.
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Other examples include research and production services in the fields of medicine, biotechnology, pharmaceutical development and medical devices and/or assistance in preclinical and clinical studies.
The sponsoring entity leverages the focused expertise and experience of the CRO, thus avoiding the need to establish the necessary know-how and infrastructure in-house and benefiting from saved time and investment costs – considering how much speed matters in the biopharmaceutical industry.
Contract research organizations specialize in tasks which require vast amounts of focused expertise and specific equipment, one example being antibody production services.
One important feature of CROs is the contractual specification of duties and responsibilities of the CRO and the sponsor. This contains the necessary sharing of sufficient project related information and data to ensure smooth progress along the specified timeline.
Getting a product to the market in medicine, medical device and pharmaceutical industries is a highly complex endeavour. Contract research organizations offer stakeholders services for every step along the way, from phase I throughout the entire lifecycle of a product:
research and development phase:
preclinical and clinical trial phase:
application and review phase
After approval
Additionally, a CRO may offer more specialized services in its niche of expertise. For example, antibody development, antibody expression and production of other goods in high demand.
Read more: Antibody production companies | The role of CROs in monoclonal antibody production
Clearly, outsourcing elaborate and specialized tasks to contract research organizations benefits the sponsor – from start-ups to established manufacturers – in many ways. However, potential drawbacks should not be disregarded. The next section will focus on the pros and how to avoid the cons of working with CROs.
Collaborating with a CRO has several crucial benefits. In drug development, time is money. A contract research organization helps to save both.
CROs offer their experience and capacities – in fields like clinical development, product development, project management, commercialization, pharmacovigilance or biostatistics –, which many institutions would need to establish in-house first. This is a time and cost intensive process which is conveniently circumvented by working with a CRO.
Moreover, state-of-the-art research is a quickly evolving process and CROs are up to speed with their in-house experts and technology.
Even though working with CROs (also referred to as Clinical research Organizations) typically benefits the sponsoring party, there are potential drawbacks working with CROs. An unreliable CRO, not complying with GCP or regulations issued by the FDA, might deliver sub-par quality, leading to the need for repeat work.
This in turn could result in research and enrollment delays, increased costs, and ultimately reduce revenues due to later market entry.
The key to fruitful partnership is a good vetting process before any services are outsourced. Due diligence is of utmost importance to both the sponsoring biopharmaceutical companies and the Contract Research Organisations.
Both parties need to take their expertise, resources and capacities into consideration to arrive at a satisfying result. Nonetheless, it is good practice to include liability clauses into the contract and have robust quality assurance protocols put in place.
In the field of recombinant antibody expression services, evitria has earned great reputation for its high quality recombinant antibody production, including its capabilities to generate afucosylated antibodies.
Based on its range of services and products, evitria qualifies as a contract research organization (CRO) for antibody production.
Customers in need of high quality recombinant antibodies for their ongoing projects, or companies seeking to outsource their antibody production, could greatly benefit from partnering with evitria.
With all necessary resources and capacities in place – plus over ten years of experience in the field, partnering with evitria as their CRO will save sponsors time, capital, and the headaches of setting up their own recombinant antibody production facilities.