IQVIA, Syneos Health, ICON, and Parexel are some of the world’s largest global clinical research organizations (CROs).
These are full service global CROs with offices spread all around the world and capable of managing both small and large clinical trials across all therapeutic areas.
But, do biotechnology and pharmaceutical companies have an alternative to these gigantic CROs?
What are the advantages and disadvantages of working with these big multinational clinical trial management companies?
Should a small biotech company trust the services of smaller-sized, less known CROs to plan and coordinate its clinical trials?
Is it a risky decision to leave a phase 3, pivotal, international registration clinical trial in the hands of a mid or small-sized CRO?
Perhaps you are a biotech chief executive or scientific officer, or operations manager, thinking about this: Should we go with a large multinational CRO or may we select a less known smaller-sized clinical research organization alternative?
In this article we will discuss the implications of working with large global CROs versus choosing smaller clinical research organizations.
But before starting our discussion, let’s provide some background information about the global CRO market and some preliminary thoughts.
The Global CRO Market
Meticulous Research®, in its publication entitled “Contract Research Organizations (CRO) Market by Services (Clinical Research [Phase II, Phase III], Pre-Clinical [Pharmacokinetics, Toxicology], Laboratory Services, and others), Therapeutic Area (Oncology, Immunology), End User (Pharma and Biotech, Medical Device), and Geography – Forecast to 2027”, indicates that the contract research organizations (CROs) market may grow at a CAGR of 6.5% from 2020 to 2027 to reach $64.4 billion by 2027.
The growth of the clinical research organization market is due to the increasing need for new drugs and a growing number of clinical trials.
Nearly 85% of the global CRO market revenue comes from the clinical CRO market. This is directly related to about 50% of Phase II–IV activities already being outsourced by pharmaceutical and biotech companies [1].
Now, after having gained some insights regarding the CRO marketplace, let’s now get into the large vs. small CRO debate.
The Large vs. Small CRO Discussion
Should sponsors use big or small CROs for their clinical trials?
Let’s evaluate several aspects that can help clinical trial sponsors make the right decision.
Our discussion will be based on the following points:
- Clinical knowledge
- Full service capabilities
- Quality of service
- Local knowledge for good site selection
- Local knowledge of regulatory and administrative aspects
- Geographical coverage
- Technological tools
- Customer proximity and care
- Communication speed and responsiveness
- Price
Let’s start our analysis.
1. Clinical knowledge
One of the most important characteristics to look for in clinical research organizations is the clinical knowledge and experience their staff have about the disease under investigation.
Having clinical project managers and clinical research associates (CRAs) who are highly knowledgeable in the disease under study will of course ensure an improved management of the clinical trial.
The point here is that a deep understanding of a disease can be found in both large and small CROs.
On one hand, a multinational CRO can accumulate a lot of experience across a vast spectrum of therapeutic areas.
On the other hand, a small, niche CRO may not have handled so many diseases but it may be particularly strong in certain types of areas like oncology or medical devices.
Moreover, a CRO can possess clinical experience in certain diseases, but this expertise is also dependent on the actual person (e.g. CRA or clinical project manager) working on the trial.
Often a CRO will hire a CRA with experience in a specific therapeutic area to meet the sponsor’s requirements.
This means that a small CRO has the capacity to provide highly qualified, disease-specific personnel upon demand.
In summary, even though a large CRO can have more extensive experience across different diseases, a small CRO can be perfectly capable of having the required clinical expertise.
2.Full service capabilities
A second key consideration when selecting a CRO is its spectrum of service capabilities.
Clinical trial sponsors should look for CROs that can cover a wide range of services in an attempt to reduce the number of required vendors.
Big CROs are definitely full-service providers having a large portfolio of the capabilities needed in a clinical study.
Nevertheless, you can also find small CROs that are able to take care of most of the study service needs.
For example, it is common to see small and medium sized clinical research organizations offering specialized services like data management and biostatistics, in addition to clinical operations.
In any case, multinational CROs will, in general, provide a more comprehensive catalog of services compared to smaller companies.
For instance, the world’s biggest CROs have their own central laboratories for biological sample analysis and medical imaging.
If you select a small CRO, these central labs would normally be hired using additional suppliers, which increases administrative and operational complexity to the project.
In short, working with global CROs may allow sponsors to reduce the number of different vendors by benefiting from a more complete, unified service offering.
3.Quality of service
CRO service quality is of utmost importance when it comes to clinical trials.
The quality of clinical trial operations and the reliability of the resulting data becomes crucial when seeking the commercialization of a drug.
One of the main reasons sponsors may select a global CRO is the assurance that these large organizations have plenty of experience managing clinical development programs and bringing new drugs to the market.
Therefore, going with a multinational CRO is considered as a safe bet, as far as quality is concerned.
However, there are not so many reasons to think that a small CRO is likely to fail in terms of quality.
There are effective mechanisms to ensure that a small CRO meets the quality aspects required to manage a clinical study, one of them being audits.
Actually, a sponsor should always audit a CRO before confirming its selection.
Through audits, a sponsor will be able to review the quality system of a CRO; its expertise, capabilities, structure, standard operating procedures (SOPs), and resources.
In general, CROs (regardless of their size) comply with the quality standards expected in the clinical research industry.
Quality is essential in clinical trial management so a CRO lacking quality is not likely to survive for long.
In summary, high-quality service can be obtained from both large and small CROs. Then, quality management as such is not so directly related to company size, as long as a strong internal quality system is in place.
4.Local knowledge for good site selection
Site selection is a critical factor for the success of a clinical trial.
Having the right hospitals and principal investigators becomes the building block to ensure that sufficient patients will be recruited on time.
CROs can play a key role when it comes to selecting clinical sites in a given country. This is particularly relevant when the sponsor is planning a study overseas (e.g. a US biotech conducting a trial in Europe or in Asia).
Therefore, a CRO with strong local knowledge becomes a valuable asset to identify good investigators and sites that can provide the patients the sponsor is looking for.
Based on their prior experience in previous trials, CROs possess clinical site and investigator contacts and databases that can be very useful in the site selection process.
Normally, due to their wider experience and larger number of previous studies, bigger CROs may have a more extensive list of recommended sites and principal investigators classified according to therapeutic area.
Smaller, niche CROs specialized in specific therapeutic areas, may not have so many references of sites and investigators outside of their area of expertise.
In any case, depending on the disease under research, a sponsor might consider working with a small CRO that is well experienced in a specific niche.
For example, a small CRO specialized in oncology, and particularly in rare tumors, will be the perfect option to identify and select top sites able to recruit well patients with those cancers.
When talking about site selection, the local knowledge of the CRO is a decisive factor.
Assuming that both the small and the multinational CRO have local physical presence in a given country, both organizations are in a position to help the sponsor select the right sites.
It is worth noting that small, boutique CROs may have more personal links with networks of local academic investigators, working on specific diseases, which can facilitate a quick identification of suitable sites.
5. Local knowledge of regulatory and administrative aspects
Conducting clinical trials in any country requires interaction with local regulatory authorities (e.g. FDA in the United States, MHRA in the United Kingdom, or AEMPS in Spain).
National regulatory authorities supervise the use and commercialization of drugs and evaluate clinical trial applications.
A clinical trial cannot be performed unless the corresponding regulatory authority has given the green light.
Clinical research organizations —regardless of their size— are capable of adequately handling the regulatory aspects of clinical trials.
Both large CRO corporations and small CROs are knowledgeable about local regulatory requirements, processes, and authorizations.
Therefore, regulatory expertise is not a critical factor in favor or against big or small CROs. They all can do equally well.
The same happens with other administrative study-related aspects such as interactions with ethics committees and local site contracting.
Large and small-sized CROs having local staff in a given country should be able to handle this paperwork with proficiency.
6. Geographical coverage
When a clinical trial needs to be performed internationally —involving various countries— the geographical coverage of the CRO becomes crucial.
Large global studies can include a long list of countries in different continents and the operational complexity of the project can be quite high.
In these types of large clinical trials —including multiple countries and a high number of patients— global clinical research organizations can be particularly effective.
Companies like IQVIA, Syneos Health, ICON, or Parexel will have offices and staff in several countries ensuring the required bandwidth to cover large-scale studies in many territories.
Small local CROs do not have this kind of wide geographical reach and sponsors planning big global trials may not want to use a small CRO unable to manage such multinational projects.
Nevertheless, small CROs are still able to manage international studies covering some countries. For example, a small-size CRO in Spain could be able to lead an international trial including other EU countries like Italy, France, and Germany.
A small CRO would typically do this by partnering with other similar CROs in those other countries.
This multi-CRO approach is not a bad solution if the total number of involved nations is not so large.
However, this multiple CRO collaboration model becomes a challenge from an operational point of view when the amount of countries is too high (i.e. 6 countries or more) since a lot of international coordination is required.
Small and medium-sized CROs are still a good option if you do not need to manage vast territories.
In any case, if your study is truly large and global, hiring a multinational CRO may be the best choice.
7. Technological tools
Clinical trials require the use of different technological tools such as electronic data capture (EDC) systems, electronic trial master files (eTMF), interactive web response systems (IWRS), and medical imaging platforms, among others.
These types of technologies can be provided by both large and small CROs alike, so there are no real implications in the use of electronic systems when considering the size of a CRO.
Well known EDCs like Medidata or eTMFs like Veeva are supplied by multinational CROs as well as by small niche CROs.
Therefore, clinical trial sponsors should be able to count on the right systems regardless of the CRO size they select.
Of course, they should make sure that the selected CRO will be able to facilitate the right technologies.
There are small CROs with a very strong technological background. However, this is not always the case.
8. Customer proximity and care
Customer proximity and care is a highly important aspect when selecting a clinical research organization.
I will not say that global CROs do not care about small sponsors, but normally these large organizations tend to focus on their big pharma clients and this may have an impact on the level of attention obtained by small biotech customers.
On the other hand, small CROs tend to be more personal. A small organization will typically dedicate close personalized attention to their clients, making efforts to quickly respond to their needs.
Many small CROs —as it happens in any sector— see customer care as a chance to gain a good reputation and grow their business.
We are not saying that global CROs will not offer a good service, of course, but when it comes to showing customer proximity and care for small biotech, smaller companies tend to be more devoted to the client.
9. Communication speed and responsiveness
Something closely related to customer proximity and care is communication speed and responsiveness towards the customer.
Again, very large companies —and this is normally the case in any industry—, due to their large and complex organizational structures, may be slower and less responsive.
For instance, when you request a quote to a very large company, this can take a longer time because the administrative internal processes of the organization are more complex and bureaucratic.
In principle, you may be able to obtain a quote from a small CRO in a shorter period of time. A more simple organizational structure usually means less administrative burden, and therefore more responsiveness.
Certainly, there are also multinational CROs that will respond quickly, and there are small-sized CROs that are slow to answer. We are talking about general trends.
In short, I believe sponsors will get faster service from smaller CROs, as a general rule.
10. Price
Finally, let’s consider pricing.
In general, bigger companies normally charge higher rates because they need to maintain larger structures and face higher corporate costs.
The clinical research industry is not an exception with respect to this principle. Multinational CROs will tend to offer higher prices compared to those proposed by smaller CROs.
Nevertheless, many sponsors do not see price as a decisive factor as long as the quality of the trial is guaranteed.
There is a lot of money at stake in a drug development program so you really want to ensure that your clinical trials are well done. Paying what is needed to ensure quality is a wide decision.
At the same time, you can also find smaller CROs providing high quality service at lower rates. Having a trial well managed at a lower price is twice as good.
So, what should sponsors do? Pay always more to large CROs to ensure high quality services? Or should they try to use smaller CROs in an attempt to keep good service and save some money?
My advice would be to consider the particular characteristics of your study.
Smaller CROs may provide cheaper service. I would use them to save money if this does not pose a risk in terms of quality.
Conclusion
Choose the CRO that is right for your clinical trial. How do you do this?
Both multinational CROs and small/medium-sized local CROs can do well in different scenarios.
If you are planning a rather small early phase study (e.g. phase 1) —with a moderate number of patients and one or few countries— considering a small niche CRO is always a good idea.
In this case it is very important to ensure the service quality of the CRO through an audit before the study begins.
If you are going to conduct a global, late-stage, or pivotal trial, with a very large number of patients and countries involved, using a multinational CROs can be a wise choice.
If you need more information about CRO services, please contact us: info@sofpromed.com
References
[1] Clinical Research Organizations Category Intelligence
