Which are the criteria to choose a Clinical Research Organization (CRO)?
Key criteria to select a CRO include its service catalog, experience, knowledge of the disease, access to patients, geographical coverage, quality management, responsiveness, staff continuity and proficiency, technology, financial stability, and pricing.
Service catalog
One of the first questions to be asked when selecting a CRO is whether it provides the range of services required for the clinical trial.
Clinical trials involve many tasks, so it is advisable to hire a full service CRO able to cover as many areas as possible, in order to keep the number of vendors low.
Basic services CROs should be able to offer include regulatory affairs, site selection and activation, site management, monitoring, data management, logistics, pharmacovigilance, biostatistics, medical writing, and project management.
Experience
One key consideration to choose a partner CRO is the verification of its experience.
How many years has the CRO been in the business for? How many trials has it managed? In which phases? In which countries? Does it have expertise in specific therapeutic areas?
Not only should the CRO have experience providing service as an organization, but it should count on seasoned staff mastering the ins and outs of clinical trial management.
Knowledge of the disease
The CRO staff’s knowledge of the disease under investigation really makes a difference when managing a clinical trial.
For example, project managers, clinical research associates (CRAs), and data managers of a niche CRO with expert knowledge in cancer studies will greatly help and guide the sponsor in trial design, monitoring, and data management.
Which clinical aspects should be considered when writing an oncology protocol? Which tumor assessment data are critical to ensure robust results? Which endpoints should be selected? What is the best monitoring strategy? Which details should be closely monitored to avoid undesired protocol deviations? Knowledgeable, niche CRO personnel can make highly valuable contributions in all these facets.
Access to patients
One of the valuable benefits CROs can offer to clinical trial sponsors is quick access to sites with high enrollment potential.
CROs continually interact with many hospitals and investigators, so they can recommend sites able to recruit the type of patients needed in a specific trial.
Does the CRO have contact with investigators specialized in the disease to be studied? Can the CRO provide access to hospital networks with strong recruitment capabilities?
Sponsors should select a CRO that will facilitate access to trial participants, saving them time in site selection.
Geographical coverage
Territorial service coverage becomes very relevant in clinical trials of larger size, which require the involvement of various countries.
For instance, phase 3 multicenter international trials (particularly those studying rare diseases) will need local services in each of the many countries where the research is conducted (e.g. regulatory services, onsite monitoring).
Does the candidate CRO have trial management capabilities in several countries? Is the CRO able to conduct studies in the United States and Europe? Or will it be necessary to hire more CROs to cover additional nations increasing thus the list of vendors?
Quality management
The importance of quality assurance in clinical trials cannot be overemphasized. Compliance and high quality data is everything for trial sponsors, as this is the ground on which their drug development programs rest.
Reliable CROs have quality management systems in place, in order to meet the principles of Good Clinical Practice (GCP), and international quality standards (e.g. ISO 9001).
Study sponsors should conduct vendor audits at the CRO’s facilities, for an onsite authentication of its quality control practices.
How does the CRO handle protocol deviations? Are CAPA plans effectively managed? Is the CRO’s personnel well trained? Is the company ISO 9001 certified? Sponsors should look into these aspects before delegating their projects.
Responsiveness
Although it should not be the case, getting poor attention from vendors is sometimes a reality. Some suppliers show neither closeness nor responsiveness to their clients, and this might also happen with CROs.
Clinical trial sponsors should choose a CRO fully committed to their needs, a loyal team that pays full attention to their requests.
It may happen that larger CROs could prioritize bigger clients, while leaving aside smaller projects. In these cases, a small-size, more agile CRO can be a better option.
Sponsors should detect whether they are getting appropriate attention and quick responses from the candidate CRO from day one, and highly value this service commitment when making the final choice.
Staff continuity
Many CROs have problems with staff retention, even with turnover levels above 20% for seven of the last ten years, according to a report [1].
Continuous personnel changes in a CRO can negatively affect service quality and the relationships between the CRO, the sponsor’s team, and the clinical site staff. On the other hand, long-term CRO staff continuity improves and consolidates clinical trial management processes.
Sponsors need to revise the CRO’s turnover rates to verify whether a solid skilled team will provide seamless support during the course of the study.
Staff proficiency
The CRO’s workforce should not only show continuity but also technical proficiency. Clinical trials must be handled by qualified specialists.
In order to guarantee technical ability, sponsors can audit the CRO’s internal training policies and records.
In addition, detailed CVs of the CRO’s personnel assigned to the study should be reviewed to check employee education and expertise.
Technology
Clinical trials involve multiple complex processes that generate large amounts of data. Technology plays a crucial role to ensure efficient study management and streamlined data collection, cleaning, analysis, and reporting.
Does the CRO use advanced tools to increase trial management efficiency? What kind of Electronic Data Capture (EDC) and electronic Trial Master File (eTMF) systems will be used? Have these tools shown good results in other studies?
Sponsors should look for CROs with strong technological capabilities that optimize study management and guarantee data quality.
Financial stability
Clinical trials are large projects implying substantial investments, and having to change a CRO in the middle of a study is a risk that causes technical and financial problems.
A CRO must be a trusted long-term partner not exposed to serious financial hurdles. Sponsors want to work with solid companies that insure continuity of service.
How many clients does the CRO have? How long has the company been operating for? Have revenues been increasing in recent years? Is the CRO experiencing growth?
Sponsors are advised to check the CRO’s financial health to verify the stability of such an important partner.
Pricing
Last but not least the CRO’s service rates should be evaluated. The price of service offerings may not be the most important factor when selecting a CRO, but still sponsors need to conduct their trials within budget.
Sponsors must expect sound, well structured, and detailed budgets from CROs. A number of different financial proposals should be requested, assessed, and compared.
Is the bid well organized with clear cost breakdowns and justifications? Are hourly rates within market standards? Is any budget item unclear or overpriced?
Conclusion
CRO selection requires careful examination. In order to make a well-grounded decision, sponsors should focus on evaluating the CRO’s service portfolio, expertise, clinical knowledge, access to patients, territorial reach, quality of service, workforce continuity and skills, tools, financial strength, and costs.
[1] CRO industry still plagued by CRA turnover: Report
