What Makes a Great CRO, and Which Ones Lead the Pack?
The need for better medical care on a global level is critical, and it’s this need that is the driving force behind new medical discoveries. However, the clinical stage of drug discovery is demanding, high-risk, and resource intensive; clinical research organizations (CROs) do much to support drug manufacturers by taking on some of that burden. These CROs cover activities ranging from research, tests, and project management to post-approval trials, pre-clinicals, and clinicals.
The relationship between CROs and manufacturers is one that has been built on skill and trust, giving manufacturers heightened efficiencies in time and cost; the best relationships rely on confidentiality, intensive communication management, and regulatory considerations, as well.
What Makes a Great CRO?
They key to differentiating between an average clinical research organization and a great one is determining the value that the partner adds to the medical research of pharma and bio firms. While cheap running costs used to be the primary variable for selecting a CRO in the past, with increasing public pressure on medication prices and characteristics, low cost is no longer the priority – in fact, it’s now the last priority in 2019 for choosing a CRO as a partner.
According to a recent survey by Pharma-IQ.com, the following factors were listed as the most important to consider when choosing a CRO, along with the percentage of respondents who chose each as the single most important:
- Quality of Services (57.73%)
- Reputation and Level of Experience (16.49%)
- Other (11.34%)
- Global Reach and Capacity (8.25%)
- Flexibility in Contract (6.19%)
Other variables that didn’t quite make the list, but were still cited by some participants as important, included emerging markets for example, being up to date with recent regulatory changes, and availability in certain regions.
CROs and the Trial Master File
Pharma and bio tech pros already are very familiar with trial master files, and it’s crucial that CROs are familiar with them and how they work, as well. This was another often-cited criterion used for selecting a CRO. Ivan Walrath is the Head of Audit and Inspection Quality at Pfizer. He notes how vital it is for CROs to recognize the significance of the Trial Master File (TMF), stating, “What I’ve seen when these partnerships have worked well is a good level of communication and integration between the people from the CRO and the sponsor working together to execute a trial.”
Most participants in the survey noted that they would usually review contracts only when an issue came up or as was needed on an annual basis. It should be noted that a small handful of respondents cited that reviews for them are ongoing as part of compliance oversight, but not necessarily to switch out CROs. Most also said that changing CROs would only happen “in extreme circumstances of failure to perform.”
Frequency of CRO Contract Reviews and the percentage of participants choosing each answer:
- Only when a problem arises (42.53%)
- Every 2 years (12.64%)
- Every 18 months (1.15%)
- Annually (16.09%)
- Quarterly (6.90%)
- No regular review (5.75%)
- Other (14.94%)
Terminating a Partnership with a Clinical Research Organization
The most common reason given in Pharma-IQ.com’s survey for ending a partnership with a CRO was a lack of quality, with 65% of participants naming it the #1 deciding factor. The next most common reason for changing out CROs was a high level of mistakes, with 12% of the vote. One respondent also stated that a legitimate reason for terminating a partnership with an organization was “significant failure to meet obligations of contract and missing multiple milestones without reasonable cause or appropriate risk mitigation.”
The Top 10 Pharma and Bio Tech Clinical Research Organizations
So, which companies lead the pack of CROs? They are:
- Syneos Health
- PRA Health Sciences
- Fisher Clinical Services
Other firms that attracted enough attention from survey respondents to be recognized as “rising stars” included Pivotal, PSI, PharmOlam, and Charles River Laboratories.
Ivan Walrath also points out the importance of quality in a team that works well together, explaining, “When you have a well-functioning team, even across those organizational boundaries, everybody gets behind what needs to happen from a quality standpoint, from a compliance standpoint, and other important aspects like hitting timelines.”
Working as a Team to Make It Work
Regardless of what each pharma company considers to be its most important consideration in choosing a CRO, all variables, qualities, and factors must come together in a way that complements the manufacturer with which it works; otherwise, progress with medicine development suffers.
Learn more about partnering with clinical research organizations by attending a clinical ops executives summit; reserve your seat now, because space is limited and fills up quickly!