Evaluating CROs: How to Ensure Good Laboratory Practice Measures are in Place

As of 2017, there were more than 1100 contract research organizations (CROs) operating globally, in an industry expected to grow at a rate of 7.6% between now and 2023. Some of these research organizations are one-lab specialists studying the impact of new pharmaceutical compounds on particular systems or organs, while others are multinationals who strive to be full-service, one-stop shops.

While all CROs are bound to follow the rules and guidelines governing good laboratory practice, some labs are better than others. Here’s how to spot red flags so that your company can make the best decision in outsourcing research during the costly R&D timeline.

1. Reporting: A good CRO will be open about mistakes made in the past, whether due to human error or mismanagement. A lab trying to cover up past mistakes will likely have issues with compliance or personnel that will lead to more mistakes in the future, whereas a lab that is routinely looking for, reporting on and correcting good laboratory practice errors will produce better work.

2. Human resources: CROs with effective training policies in place and a commitment to retaining their employees will produce better results. Be wary of any CRO with a high turnover rate, low company morale or inadequate training courses, as staff who are highly stressed, untrained or lacking motivation are more likely to make mistakes.

3. Geography: Some new CRO companies in developing markets are not yet able to guarantee compliance with OECD good laboratory practices guidelines, rendering the results gained from these labs inadmissible. While many still produce good work, it may not be worth the extra expense to your company to have their results monitored in order to bring them in line with OECD regulations.

In order to make the best decisions, it is critical that you have good laboratory practices professionals in your company who are up-to-date on training and have the skills and knowledge required to evaluate partnerships with CROs. Our Good Laboratory Practices Certified Compliance Professional (GLPCP) program ensures that your employees have the statistical knowledge required to comply with good laboratory practices, as well as a solid understanding of regulatory policy in this country. To learn more about certifying your facility, visit our GLP Facility Certification program page.

Sources:

https://www.igeahub.com/2018/03/15/top-10-global-cros-2018/

http://www.pharmatimes.com/web_exclusives/choosing_the_right_non-clinical_cro_1250750