Clinical How to Choose the Best Contract Research Organization (CRO) for Your Clinical Trial

Your product is in a crucial stage, requiring a thorough clinical investigation to further assess its safety and efficacy. It’s time to choose the best team to monitor your clinical investigation, but which Contract Research Organization (CRO) will you entrust your study to?

A CRO is a research center hired to take over designing, managing, and monitoring a clinical investigation for you, the Sponsor (the person or entity looking to investigate the safety and efficacy of a potential treatment).

A reliable CRO should have a quality management system (QMS) in place to meet the requirements of ISO 14155, Clinical Investigation of Medical Devices for Human subjects – Good Clinical Practice (GCP). Its staff should be well-versed, trained, and certified on the standard and must implement it daily.

Geographical Expertise

CROs should have expertise in the geographical area of the trial as well as the disease to be studied.

For example, suppose you would like to begin an early feasibility clinical investigation in a country outside of the United States. In that case, the CRO you choose must:

Have expertise in the region’s regulatory requirements for clinical trial submissions

Understand and meet the Ethics Committee/Institutional Review Board (EC/IRB) requirements

Have contacts for potential Principal Investigators (PIs) and Clinical Research Coordinators (CRCs)

Know how to export the device, the average procedural costs, data security requirements, etc.

As another example, if you have a device for treating atrial fibrillation, choose a CRO that has not solely worked on pediatric-related drug trials. Device trials tend to be simpler than drug trials, but you would likely need to conduct extra training for the CRO as the group may not be as familiar with adult-related device investigations.

Britnee Ochabski

Senior Clinical Research Associate,
ACRP CCRA, CRP

Relationships

It is valuable to select a CRO with access to many investigational sites with experienced research staff and the potential for high enrollment rates. Choosing a CRO with multiple contacts fully committed to your needs as the Sponsor is highly beneficial.

If you are a small team with minimal funding and decide to hire a large CRO for your project, the staff involved may prioritize more prominent clients while leaving aside smaller projects that produce less revenue. Should you receive inadequate services from your selected large CRO, a small-size, more energetic CRO is a better option.

Remember, the ideal CRO should consist of loyal and trustworthy team members who can commit to constant communication with you and your selected investigational site staff. The CRO/Sponsor relationship (as well as the CRO/Site Staff relationship) should be professional, consistent, and transparent from the beginning to avoid miscommunication and duplicate activities.

Technologically Savvy

An experienced CRO can offer services for single-site and multi-site investigations, such as regulatory support, study and site start-up logistics, site management, monitoring, data management, medical device vigilance, biostatistics, report writing, and overall project management. It would help if you also looked for a group with strong technological capabilities that optimize study management and guarantee data quality.

Choosing a CRO that has experience with multiple Electronic Data Capture (EDC) systems, Electronic Medical Record (EMR) systems, electronic Trial Master Files (eTMFs), and electronic Regulatory systems (eReg) can allow your study to move quickly and smoothly as familiarity with systems can result in less time for training the CRO staff, allowing them to work quickly and independently.

Additionally, choose a technologically experienced CRO. Its selected staff can provide resources on which systems to choose for your study (which EDC is the best, which eReg system is the most affordable, which eTMF system is the most commonly used, etc.).

Affordability

Most new Sponsors have a relatively low budget and select an affordable CRO with little experience. Sometimes, they may even try to run the study themselves before realizing they need to hire a CRO.

For more experienced Sponsors, the price may not be the most critical factor when selecting a CRO but the experience and quality of the CRO. However, even experienced Sponsors have a limited budget and, ultimately, must opt for the CRO that can offer and deliver the most value for their budget.

Whether or not you are an experienced Sponsor, you should always choose a seasoned CRO at an affordable rate to ensure you stay within your specific budget without compromising the quality you expect.

Specific Characteristics

When interviewing a CRO, you should be looking for the following characteristics among staff members:

Multi-Disciplinary

Staff should have experience and knowledge across multiple disciplines to approach and manage numerous studies. Often CROs have various members with a myriad of specific specialties to meet the needs of any Sponsor.

Curious

Staff should be asking questions about vague concepts and topics requiring more discussion. A good CRO does not take documents at face value but asks the Sponsor questions along the way to ensure they meet the requirements of both the study and the Sponsor.

Empathetic

Staff should be able to understand and empathize with the needs and feelings of both the Sponsor and site staff to deliver messages appropriately, make necessary updates, etc. While CRO monitors are known for being strict and cold, if the Sponsor and site staff respond well to empathetic monitors, they may be more willing to provide data quicker and with more accuracy.

Critical Thinkers

A good CRO is rational, skeptical, and unbiased when evaluating factual evidence. Staff should be able to review available facts, evidence, observations, and arguments to conduct a final, impartial study data analysis.

Ethical

CRO personnel should be well-versed in the influential codes of ethics and regulations that guide ethical clinical research, including the Nuremberg Code (1947), the Declaration of Helsinki (2000), the Belmont Report (1979), and the U.S. Common Rule (1991). Staff should also be certified in Good Clinical Practice (GCP) to display their competence in the international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical investigations.

Honest

CROs should always display honesty and integrity as clinical trial staff. The staff should only align their actions with the protocol's requirements and local and federal regulations.

Flexible

Staff should be able to adapt quickly when unforeseen circumstances arise. A good CRO is flexible, versatile, resilient, and responsive to change. If staff seem to have a support network, they are more likely to be understanding and open-minded to change.

Great People Skills

CROs often work in teams and already have excellent people skills. However, it would be best to analyze it closely during your interview. Specifically, you should examine the following:

How do staff get along with each other and new people?
How do they demonstrate leadership?
Do they seem organized and thoughtful in their conversation?
Can you detect a sense of humility?

Track Record

There is a wide variety of global CROs who all have different expertise. Some CRO groups are privately owned and funded, while others are publicly held companies. When comparing one organization to another, you must look at each company. Do both companies have similar expertise, budgets, timelines, and overall experience? Which company do you find to be more flexible, curious, and empathetic?

Choosing the right CRO after conducting only a few different interviews may be challenging, so reaching out to various colleagues for advice on the best CRO company to fit your needs and who they have had a good experience with is helpful. Remember, a CRO's overall track record in the industry is vital to consider, and in fact, word of mouth is how many CROs are hired.

The Biotex CRO, A Reliable Choice

The Biotex CRO operates as both an in-house CRO for Biotex's novel medical technology and as a contract CRO for outside Sponsors looking for a group to monitor their upcoming clinical investigations. We provide:

Study and site start-up services
Documentation writing (including protocols, informed consents, case report forms, etc.)
Virtual and in-person monitoring
Data management
Regulatory documentation management
Expertise relating to data monitoring committees and EC/IRB submissions/approvals
Investigator and staff training
Regulatory affairs consulting, safety management
Biostatistical consulting
Other related services

Our team consists of motivated and experienced Clinical Research Associates (CRAs) to assist clinicians, scientists, engineers, and fellow researchers in bringing their life-saving products to market.

When you choose Biotex as your CRO, you are not only selecting an experienced organization, but you are also teaming up with a group known for being analytical, principled, authentic, and compassionate. We have a myriad of clinicians, Sponsors, and Investors that have previously endorsed Biotex as a company they can rely on.

Contact the Biotex CRO for more information on how we can help you with your clinical investigation needs.

About the author:

Britnee Ochabski is a Senior Clinical Research Associate (CRA) with an ACRP certification for CCRA and CP who developed the clinical program at Biotex and currently manages the Biotex CRO+. Since 2015, Britnee has managed several clinical investigations involving devices and drugs at various institutions and sites inside and outside the U.S., involving national and international travel. She is a reliable CRA with knowledge in all research areas, including clinical and regulatory requirements for a seamless U.S. or OUS EC/IRB approval. She is known for her strong ethics and commitment to quality patient care.