As oncology drug developers, you likely know that selecting the proper Contract Research Organization (CRO) for your Phase 1 clinical trial is a crucial step in bringing your treatment to the market. This article provides insights for oncology drug developers when selecting a CRO for an Early Phase Oncology Trial.
What is a CRO?
A CRO is a company that specializes in contract research and development. They help companies by providing the services they need to conduct their research – from designing and carrying out tests to procuring and shipping samples to researchers. CROs typically have a wide range of experience, from conducting fundamental research to more complex projects. In addition, most CROs offer their clients access to a large pool of talented researchers.
Benefits of working with a CRO for your Early Phase Oncology Trials
A contract research organization (CRO) can be a valuable asset for oncology drug developers. Benefits of using a CRO include:
- Reduced cycle time. A CRO can help speed development by providing resources and expertise in data management, clinical trial design, and study monitoring.
- Increased efficiency. A CRO can help reduce the number of interactions required with various stakeholders, allowing more time to focus on the actual development of the drug.
- Reduced risk. A CRO is typically more experienced and knowledgeable than individual researchers regarding complex clinical trial protocols and study designs. This means there is less risk of errors or missteps during development.
- Improved communication and collaboration. A CRO can help ensure that all stakeholders are up-to-date on project milestones and developments, leading to improved collaboration and communication between team members.
One of the challenges for oncology drug developers is finding a CRO specializing in Early Phase clinical trials. Adding oncology to the mix makes that challenge even more significant.
A CRO with Early Phase Oncology Expertise
So, a CRO’s focus is essential. Be sure to enquire about their organization’s expertise in early phase clinical trials. Some CROs may focus more on this type of trial, while others may be more generalists. Suppose a CRO only has experience conducting later-phase clinical trials. In that case, it may not be able to adequately guide your project through all of the unique challenges and pitfalls that can occur during early phase clinical trials.
And find out whether the CRO has any experience working with your target cancer type or drugs. For example, if your target cancer is rare or your drug is not yet available on the market, a CRO that is inexperienced with this type of project may not be able to provide adequate support.
Things to keep in mind when choosing a CRO for your Phase 1 Oncology Trial:
- Make sure the CRO has the experience you need. They should be able to provide you with information on specific projects and research areas and help you find researchers who can meet your needs.
- Make sure the CRO is reputable. Look for organizations that have been in business for many years and have a good reputation among scientists.
- Be sure to discuss your project with the CRO before starting it. They can advise on how best to carry out your research and help you find the resources necessary for your project. When hiring a CRO, it is essential to ask these questions: – What kind of projects does this company do? Do they have a variety of research areas?- What kinds of services will the CRO provide? Will they assist in finding suitable researchers or other individuals to work on your project?- How long has the organization been around, and what are its credentials?
- Ask whether the CRO is affiliated with a university or medical institution. Some CROs are affiliated with academic institutions, which can provide additional resources and support.
- Determine whether the CRO has national accreditation and, if so, what type of accreditation it holds. Accreditation indicates that a CRO has demonstrated professionalism and experience conducting clinical trials.
- Check the CRO’s website to learn more about its history and areas of expertise. For example, a well-established company will have many years of experience in the field. In contrast, a new company may be focused on particular types of clinical trials and research endeavours.
- Contact references from previous clients to find out what kind of support they received from the company or service. A good service provider will have several satisfied clients who can attest to the quality of its services and its responsiveness to the needs of its customers and patients.
Like anything else you purchase, or consider purchasing, make sure you’re getting value for your money.
How CROs are Used in Early Phase Oncology
Contract research organizations (CROs) have become an integral part of the drug development process for oncology drugs. They play a vital role by providing a cost-effective means to test new cancer therapies in humans. Additionally, CROs can help speed up drug development by performing preclinical and clinical trials more efficiently. However, choosing the right CRO is crucial for success in oncology drug development.
Below are five tips for selecting the best CRO for your oncology drug project:
1. Evaluate your project’s needs. Before hiring a CRO, it’s vital to assess what services they offer and whether those services are necessary for your project. For example, some CROs specialize in certain areas of drug development, such as clinical trials or preclinical testing. Make sure to ask which areas of drug development they are experienced in and whether they have the necessary resources to complete your project successfully.
2. Consider budget constraints. Although not all CROs charge equal rates, budget is always a factor when choosing a CRO. It’s crucial to find a CRO that charges a reasonable rate that reflects the quality of its services. Some good quality indicators include experience, track record, the number of clients the CRO works with, and professional accreditation.
3. Ask about time constraints. When considering a potential CRO, ask if they have time constraints when it comes to completing your project successfully. For example, for some projects, you need to work quickly and expect that the CRO will be able to complete the project within a specific time. If this is the case, ask when that period is and how long it usually takes them to complete such projects.
4. Consider how many people will be working on your project at a given time. Certain CROs may not have enough people available to work on your project at all times, but others do have the staff resources you need when needed most. To find out which kind of CRO will be able to deliver the best results, you need to ask the right questions. For example, ask how many employees work there, their experience level and what type of projects they can complete most successfully.
5. Consider where your project is being done. You likely want a CRO that can do what it takes to deliver on time and with the quality, you’re looking for – especially if you’ll be paying them for the project. Consider whether or not this company offers finished products in your country and if they have previously completed other projects in your area of expertise.
As a drug developer, you have many responsibilities and tasks that need to be completed to bring your product to market. One of the most important decisions you will make is who will do the contracted research on your behalf—choosing the proper contract research organization for your project and some key considerations to keep in mind. By following these tips, you can ensure that your contracted research is executed successfully and meets all of your expectations.
Biomapas Nordic AB Appoints Ola Jeppsson to CEO & Business Development Director
August 2021 Ola Jeppsson has taken on a leading role as Business Development Director. In addition to his new role, he was appointed as a Chief Executive Officer at Biomapas Nordic AB starting August 2021.Having a management and business development background in the...
7 Reasons To Include Eastern Europe In Your Clinical Trial Strategy
Choosing the right set of countries, sites and investigators for a clinical trial are critical success factors in any clinical development program. They can guarantee speedy patient recruitment and timely delivery of study results. It also ensures that you conduct...
Clinical Study Start-Up: Is there any Difference Between Western and Eastern Europe?
This article reviews Clinical Study Start-up Differences Between West & East Europe, timelines, and processes. Medicine is constantly evolving to invent effective ways to treat diseases. This progress is a never-ending process: the life science industry develops...
Running a Clinical Trial in Ukraine
Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction, country has utilized only 15% of its current potential for hosting clinical trials. During 2017, the European Medicine Agency (EMA) gave positive recommendations on 94 new drug applications and 49 of them were tested in clinical trials in Ukraine. During the same year, the US FDA approved 151 new drugs, and 28 of them were also studied in Ukraine.
What You Need to Know about Running a Clinical Trial in Russia?
Russia is a very perspective country for international clinical trial conduction. The first international clinical trial was set up in Russia about 20 years ago only, and from than country kept a great potential for market development. In 2018 health authorities (HAs) approved 653 clinical trials (CT) in Russian Federation, less in overall numbers compared to the same indicator from 2016 – 898 approved CTs. However, this decrease was observed across all types of clinical trials except for international multicentre clinical trials (IMCT).
The CIS Region: Excellent Potential for Patient Recruitment but is there any Risk to Quality?
The number of clinical trials worldwide is increasing more than 10% each year due to the new diseases, further research for better health products and development of new drugs. Though, for a successful clinical trial, there is a major challenge – patient recruitment, which is essential and the most challenging factor due to the increasing number of new clinical trials. In order to achieve the required patient recruitment, sponsors are looking for different solutions.
Running a clinical trial in the Baltic states
In the past five years, an average of 175 clinical trials are being initiated in the Baltic states each year. An average of 64,8% of the population in the Baltic states are in the age from 15 to 65 years old, the main target audience for clinical trials. Furthermore, a large pool of treatment-naïve subjects is available compared to other EU countries or the US. Patients with special therapeutic diseases are transferred to the main central hospitals.
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)
On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.
Tuberculosis Medicines Clinical Development in Eastern Europe and CIS
World Tuberculosis Day is commemorated every year on 24th March to raise awareness of tuberculosis, which is still causing death of nearly 1.5 million people each year, mostly in developing countries. It marks the day in 1882, when Dr. Robert Koch announced that he had discovered the cause of tuberculosis, the TB bacillus. In comparison to other infectious diseases caused by a single infectious agent, tuberculosis is the second biggest killer worldwide.
AICROS Annual Meeting: insights and future perspectives
The Association of International Clinical Research Organizations (AICROS) is a network of small to mid-size CROs, which provide clinical research services to the pharmaceutical, biotech and medtech industries. Biomapas joined AICROS in 2014 and since then has been an active member of the association. On the 20-22 February, Biomapas’ CEO Audrius Sveikata participated in the AICROS Annual meeting, which took place in Tel Aviv, Israel. Audrius shared his insights about the meeting and the future perspectives of the association.
