Contract Research Organisation (CRO)

TRACER specializes in first in-human studies. In early Phase clinical research, the first in human study is the most pivotal. The first in human phase bridges the gap between preclinical and clinical. By replacing a part of the preclinical drug development with exploratory in-human trials, such as Phase 0, we move compounds faster into the clinic. Allowing drug developers to save precious time, obtain early proof of concept, and make an accurate and fast go/no-go decision for a lead compound candidate.

TRACER is a contract research organization with headquarters in the Netherlands. Via our clinical research network, we offer global contract research organization services. However, since we are based in Europe, we maximize the advantages of local and EMA fast regulatory approval processes. Contact us for an optimal clinical site location.

There are several reasons to consider partnering with a clinical research organisation in Europe. Conducting clinical trials in Europe is often fast due to fast regulatory approval. But the advantages don’t end there.

1. Diversity in clinical trials is possible due to varying demographics, ethnicities, and disease prevalence.
2. European hospitals are of the highest standards in the world, with state-of-the-art imaging facilities.
3. There is a vast network for research.
4. There is a high global acceptance and trust in EU clinical trials.

Two disadvantages of EU clinical trials to take into consideration are relatively higher costs compared to more emerging markets and potential linguistic challenges.

Outsourcing clinical trials is a standard practice in drug development. Many drug developers work with a contract research organisation for clinical outsourcing. Outsourcing is providing drug developers with instant access to the expertise and existing infrastructure of a CRO. A full service CRO already has all protocols in place, from regulatory submission to data management. Different specialists are involved in clinical research. By outsourcing clinical trials to a CRO, you don’t need in-house personnel.

TRACER is a pharmaceutical contract research organisation. We work in the biotech sphere, so our clients are mostly pharmaceutical companies, independent drug developers, academia, and university spin-offs. Our clients range from large pharmaceutical companies to small biotech start-ups. As needed in the early phase of drug development, we provide services within the scope of a contract research laboratory and pharmaceutical contract research in the clinic.

Why would you choose to work with a smaller contract research organisation instead of the top contract research organizations? Often small CRO companies are highly specialized. For TRACER, the specializations are imaging and exploratory trials. For you as a drug developer, the notable advantage is the dedication to your project that a small CRO can offer. This trickles down to the clinic because there is continuous personal contact between the CRO and the clinic. In general, there is a high level of flexibility. A small contract research organisation can tailor the situation to the needs of you as a client. Whereas with larger CROs deviating from protocols can be challenging or impossible. Moreover, costs may be lower due to lower overheads.

The expertise of a pharmaceutical clinical research organization mainly consists of compound/device type, therapeutic area, technique, subjects (patients or healthy volunteers), and phases of drug development (early phase / late-phase drug development. E.g., a dermatology contract research organization specializes in skin, nail, and hair conditions while oncology contract research organizations focus on cancer therapies. The choice in CRO can depend on your compound, but also on phase of development and technology. To elaborate further, at TRACER we often use imaging methods such as fluorescent and Raman in dermatology. In oncology clinical trials, targeting deeper tissues, we use PET/SPECT.

Yes, it is not uncommon that drug developers choose for early phase clinical trials small contract research organizations due to a specialty. For the large Phase 3 clinical trial, a larger CRO can be chosen. An important aspect to understand from contract research is that if a study is conducted properly and well-documented, other researchers can easily continue or cooperate.

The best contract research organization is the one meeting your needs the best. Where the contract research organization services are within the scope of your research and where the expertise of the CRO delivers you more relevant data from the same clinical trial.

Contract research organization companies support pharmaceutical and medical device companies in their research. Contract research can be found in every phase of drug development, from discovery to clinical trials and pharmacovigilance. Contract research organisation is an umbrella term. What a contract research organisation does, depends on its type and niche. We compare below this FAQ the most common types of CROs and discuss the scope of their work.

A preclinical contract research organization focuses on laboratory research such as animal studies and in-vitro studies. A clinical contract research organization conducts studies on human subjects. Clinical research involves more regulation, patient recruitment, and monitoring. For you, as a drug developer, it is important to know that part of the late preclinical phase can be replaced with exploratory clinical trials under ICH M3 guidance. TRACER can work together with your preclinical CRO to ensure a smooth translation into the clinic.

What is the difference between a contract research organization and a Medical Research Organization (MRO)? While both definitions are comparable, there are some differences. A contract research organization is a service provider, while a medical research organization often conducts research on its own initiative. For instance, an MRO can be an academic, government, non-profit, or private institution. Their research scope does not have to be focused on drug development and can also include disease mechanisms, health trends, and risk factors. In other words, an MRO can work as a stand-alone organisation, where contract research organization pharmaceutical companies always work together.

What is the difference between a clinical research organization and a contract research organization? The definitions clinical research organisation and contract research organization are highly interchangeable. A clinical research organisation is a type of CRO, that primarily performs research in the clinic, meaning patient studies. There are multiple types of clinical research organizations. The biggest difference is in CRO pharma vs CRO for medical devices. A drug development CRO, meaning pharma, can be specialized in types of compounds. For medical device CROs, differentiation is in the type of device, e.g., surgical equipment, wearables, diagnostic/imaging systems, drug delivery devices, etc.

The SMO Site Management Organization provides support at the research site. This is often in the hospital. Site management can also be a separate function at a clinical contract research organisation or can be part of the project manager’s tasks. At TRACER our physician-scientists are performing the tasks of the SMO organization. Meaning we provide this as an in-house service; our physician scientist works at least one day a week at the site. Tasks of site management organisation in clinical research are study start-up, study conduct, patient recruitment, and quality assurance. By working at the hospital, and being present at relevant handover meetings, good relations and short lines of communication are assured.

CDMO stands for Contract Development and Manufacturing Organization, but can also be referred to as contract research and manufacturing organization. In the past, it was referred to as CMO (Contract Manufacturing Organization), but to avoid confusion with abbreviations for Chief Medical Officer and Clinical Monitoring Organization, the D from Development was added. A CDMO differs from a CRO in the manufacturing/development aspect. Often a CDMO manufactures the material for the clinical trials but can assist drug developers at a wider scale, from formulation development to eventually commercial production. They can manufacture for the contract research organization clinical trials materials.