The cost of hiring a clinical research organization (CRO) to conduct a clinical trial can be quite high, to the extent of being prohibitive.
In the United States, biotech companies can pay between $1 and $2 million for CRO staffing services alone to conduct a Phase 1 clinical trial —to recruit about 15 patients— not including other third-party expenses (e.g., software tools, payments to hospitals, or monitoring trips).
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Of course, these numbers do not include the manufacturing of the drugs, nor the logistics required to ship them to hospitals, which increases the cost of the clinical study significantly.
Planning and executing a clinical trial is a multi-million dollar task, and the biotechnology and pharmaceutical companies that embark on these studies require several million dollars to complete the development programs for their compounds.
However, is it possible to lower the price of clinical trials? How can a trial be carried out with less money while maintaining international quality standards?
Clinical Trials with Lower Budgets
Not all clinical trial sponsors have large amounts of funding to conduct their research in humans.
In fact, there is a type of clinical research that does not have commercial objectives and is performed with more modest budgets.
At the same time, there are also commercial sponsors who may find it quite difficult to secure the required funding at the right time.
Investigator-initiated academic studies
An example of lower-cost research is investigator-initiated clinical trials, which are usually non-profit academic studies designed by specialized physicians.
In investigator-initiated academic clinical trials, the main objective is not the future sale of a drug, but the advancement of science and the possibility of offering patients new alternative therapies, especially for diseases with a high medical need.
It is common that these academic studies do not have a large budget, since they are not directly sponsored by biopharmaceutical companies, nor are they trials on which the approval of a drug depends.
On many occasions, lower-budget academic clinical trials are funded by research grant programs, frequently in the form of public grants from governments.
Nevertheless, even if they have less funding, academic sponsors need to carry out their clinical trials in compliance with international quality standards.
Commercial studies with limited funding
In any case, investigator-initiated academic trials are not the only studies that may have a low budget.
Even commercial sponsors seeking to bring a new compound to market may need to conduct clinical trials on tight budgets.
Indeed, finding investors and raising large amounts of funding to conduct clinical trials is becoming an increasingly difficult task.
Therefore, it is not uncommon for a small emerging biotech company to have the need to run a clinical trial at a lower price.
How Can a Clinical Trial Be Conducted with Less Money?
When the budget available for research is limited, the key question is: Is it possible to carry out a clinical trial with less money?
Fortunately, the answer to this question is yes, it is feasible to perform a clinical trial with a lower budget.
Running a trial without a CRO?
Sometimes biotech companies consider the possibility of conducting a clinical trial without hiring a CRO, that is, they try to plan and execute the study with their own staff.
A priori, not hiring the services of a CRO might seem like a good option, because, after all, the expensive services that CROs normally offer do not have to be paid for.
Nonetheless, the alternative of not using a CRO is not as simple and happy as it sounds, since running a clinical trial requires hiring and maintaining highly qualified personnel.
In other words, if a biotech company chooses to dispense with a CRO, it will have to invest great efforts in creating and maintaining a structure of specialized clinical trial professionals, including administrative assistants, clinical research associates (CRAs), project managers, data managers, statistical programmers, logistics experts, and quality managers, among several other roles.
Creating and sustaining such a structure also costs money, to which must be added recruitment and training efforts, and the difficult task of retaining employees in a fiercely competitive environment with high turnover rates.
For these reasons, forming an “in-house” CRO within a biotech firm —in an attempt to save costs— can become a time-consuming and complex challenge.
Conducting a trial with a low-cost CRO?
Then, if doing a clinical trial with in-house staff is also complicated, what alternative is left?
Although it may seem surprising, there are CROs that can offer cheaper rates while maintaining good service quality standards.
Below we will explain how a CRO can offer its services at a more economical price, reducing costs for its clients.
How Can a CRO Offer a More Economical Service?
The following are some strategies for a CRO to offer a cheaper service (always maintaining good quality standards):
1.- Lower personnel costs thanks to a leaner structure
When a company is small —it does not have many employees— its internal infrastructure costs are lower, which allows it to offer cheaper prices to its customers and still make a profit.
This is also true for CROs. Multinational CROs with thousands of employees offer their services at higher prices to cover their expenses and make the required profit.
On the other hand, smaller CROs —which may even have fewer than 100 employees— have the ability to offer reduced staffing rates, which makes them more competitive on price.
In this way, a smaller CRO with a lighter operating structure has the advantage of being able to offer lower budgets, making it an ideal partner for sponsors who need affordable prices.
2.- Lower-cost qualified personnel located in other countries
Another factor that directly impacts a CRO’s personnel costs is the location of its human resources.
In countries with strong economies —such as, for example, the United States, the United Kingdom, or Switzerland— employee salaries are high and, as a result, CROs that use staff in these territories offer high prices.
However, if a CRO employs people located in countries with less powerful economies, there is the possibility of offering much more competitive prices, which is very convenient for clients.
It is sometimes mandatory to use local staff for certain tasks within a country.
For instance, if the trial is conducted in the United States, it will be necessary to employ professionals who live in the United States for activities such as monitoring in hospitals, which requires face-to-face visits in American cities.
Despite that, clinical trials include tasks that can be done remotely, such as data management and statistical programming.
A CRO managing a study in the United States may choose to use some local resources within the US but also people located in Europe —or other continents— for remote activities that are not affected by time zones.
This strategy of using specialists in different countries —where labor is cheaper— allows the CRO to offer more competitive prices, thus saving costs to its clients.
3.- Recruiting clinical centers located in more economical countries
One of the most expensive budget items in clinical trials is the amount of money to be paid to hospitals for medical tests and procedures, for each patient recruited into the study.
In the area of oncology, for example, these expenses would include blood tests, radiological tests for measuring tumors, hospitalization of patients, chemotherapy treatments, etc.
The reality is that the money needed to pay hospitals in some trials can be substantial.
As a matter of fact, a highly prestigious hospital in the United States may charge between $30,000 and $60,000 per patient in an oncology trial to cover the tests and procedures of the study, not counting start-up costs.
If 50 patients are included in such a trial, we would be talking about a total of up to $3,000,000 for these items alone.
In view of these high figures, the alternative is to look for clinical centers where the price per patient is cheaper.
Lower prices per patient can certainly be achieved if the sponsor decides to open participating hospitals on other continents.
To give an example, the costs per patient that can be obtained in hospitals located in Spain or in Eastern European countries can be 30% to 40% lower.
4.- Cheaper but equally good technological tools
Finally, another very relevant source of savings is the selection of the technological tools that will be used in the trial.
At least two software tools are essential in clinical trials: the electronic Case Report Form (eCRF) and the electronic Trial Master File (eTMF).
eCRF and eTMF applications of different prices are currently available on the market.
The most expensive eCRFs —for studies with many patients— can cost about $6,000 per month, while a high-profile eTMF can be priced at about $3,000 per month.
The good news is that there are considerably cheaper eCRFs and eTMF providers —of guaranteed quality— that can cost as little as $1,500 and $500 per month, respectively, which means more than remarkable savings.
In short, there is always a way to do things well while spending less money, and this is what many clinical trial sponsors need today.
Sofpromed: The Low-Cost (and High Quality) CRO
Sofpromed is a CRO that stands out in the market by offering high quality services at very affordable prices in the United States and other territories.
According to our estimates, our prices allow for savings of at least 30% compared to large CROs.
Sofpromed is a small CRO with a lean structure —under 100 employees— which positions us perfectly to offer highly competitive staffing rates, even for trials in the United States.
Some members of our teams operate from Europe, so we can offer better rates and guarantee the completion of trials involving hospitals located in European countries (Spain, France, Poland, Slovakia, among others).
Moreover, our CRO distinguishes itself as a fast and responsive partner, a feature of great value for our customers.
Biotech companies developing new drugs do not have to resign themselves to spending large fortunes to carry out their clinical trials.
It is possible to conduct clinical trials with excellence at a competitive price if the recommendations and strategies discussed in this article are considered.
Sofpromed offers affordable prices —while ensuring international quality standards— and enables emerging biotech companies to develop their clinical programs while gaining the most out of their investment.