03.09.2021 duration: 3 min

What is a contract research organization (CRO)?

Contract research organizations (CRO) provide research services on contract basis to biotech, pharma and medical device industries as well as academic institutions.

This post will highlight the core activities in the growing market of CROs, 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.

That’s what a contract research organization does!

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.

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.

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.

Interested in recombinant antibodies?

    Services offered by Contract Research Organizations

    Getting a product to the market in medicine, medical device and pharmaceutical industries is a highly complex endeavour. Contract research organizations offer services for every step along the way:

    research and development phase:

    • chemical, biological and pharmaceutical knowledge
    • formulation expertise

    preclinical and clinical trial phase:

    • project and data management
    • database design and implementation
    • patient recruitment
    • quality assurance
    • safety and efficacy reports
    • statistical analysis
    • validation
    • evaluation and reporting

    application and review phase

    • study report submission
    • assistance in correspondence with regulatory agencies

    After approval

    • marketing assistance
    • post-market safety monitoring

    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.

    Benefits and considerations of outsourcing to a CRO

    Clearly, outsourcing elaborate and specialized tasks to contract research organizations benefits the sponsor 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.

    Benefits of working together with a CRO

    Collaborating with a CRO has several crucial benefits. When bringing a product to the market, time is money. A contract research organization helps to save both. 

    CROs offer their experience and capacities, 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.

    Quality factor in recombinant antibody production

    Considerations before partnering with a CRO

    Even though working with CROs typically benefits the sponsoring party, there are potential drawbacks working with CROs. An unreliable CRO might deliver sub-par quality, leading to the need for repeat work. 

    This in turn could result in research 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 companies and the CROs. 

    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.

    Is evitria a contract research organization?

    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

    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 tenyears 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.

    Previous article Recombinant protein expression – an overview
    Next article How to select a CRO for your recombinant antibody production?

      Subscribe to the evitria newsletter and stay up to date