What is a clinical research organisation?
By definition, a clinical research organisation (or ‘CRO’) is a company contracted by a pharmaceutical, biotech or medical device manufacturer to manage clinical research and other services to support drug discovery and development.
The main role of a CRO is to facilitate clinical studies, ensuring they’re conducted efficiently, ethically and in compliance with regulatory requirements.
Clinical trial design and planning. Navigating the complex regulatory requirements needed to start and run clinical studies. Patient recruitment and site management. Data collection and management. Continuous drug safety monitoring. Preparing reports and regulatory submissions. These are some of the key responsibilities of a CRO.
But at TMC, we’re more than just a CRO. At the heart of everything we do are the patients we aim to serve through clinical studies and research.
We’re a global clinical research organisation dedicated to supporting the progression of life-saving drug development solutions for rare conditions and diseases that are often neglected.
Defining a ‘rare disease’
A disease that affects less than 65 per 100,000 people. That’s the definition of a rare disease according to The World Health Organization (WHO).
Yet, cumulatively, rare disorders and diseases are not so rare at all. There are approximately 300 million people living with a rare disease worldwide.
So, why is there still a significant gap when it comes to clinical studies and research in this area?
Ultimately, this gap comes down to funding and investment. Medical research is driven by commerce — whether we like it or not — so biotechs and pharmaceutical companies must weigh up the costs of drug development compared to the returns for eventual commercialisation.
In the case of rare diseases, smaller patient populations limit the market potential for products and create significant challenges in the design and execution of clinical studies for new therapeutics, meaning these patients are often overlooked.
As a result, around 95% of rare conditions lack a regulatory-approved treatment, and the average time for an accurate diagnosis is four to eight years.
We believe this needs to change. Those affected by rare conditions and diseases shouldn’t feel marginalised or neglected, which is why it’s our mission — indeed our passion — to offer drug development solutions in this area.
For nearly 25 years, our experts have dedicated their time to supporting the progression of life-saving treatment for rare diseases worldwide. We understand the innate challenges that come with this, working with small-to-medium biotech and biopharmaceutical companies to bring treatments for rare disorders and diseases to the market.
There’s a long list of rare diseases, and we have a wealth of experience in a breadth of rare disease areas — particularly in our key focus areas of oncology, neurological disorders, respiratory diseases, haematology, ophthalmological conditions, neonatology, hepatology and nephrology diseases.
Drug development solutions for rare diseases
Our aim is to leverage our experience and expertise in rare diseases — partnering with our clients to bring potentially life-saving treatments to patients as cost-effectively and swiftly as possible.
We’re people-driven, patient-focused and proud of our philosophy of providing a service that’s flexible, integrated and tailored (‘the perfect FIT’) — with a focus on achieving the best possible outcomes for our clients and their patients.
Because every person matters.
Our services span all the drug development stages, including regulatory affairs, pharmacovigilance, clinical development and combined medical services.
So, what is a clinical research organisation?
To us, being a CRO is about working to a flexible model — with an integrated approach and a focus on tailored solutions.
We believe a CRO should have a knowledgeable and highly skilled network to call on, allowing them to adapt to the unique needs of every project and ensure the swift deployment of resources to efficiently and cost-effectively drive drug discovery and clinical development programmes.
They should want to achieve the best possible outcomes — not only for their clients, but also for the patients the clinical studies and research aim to serve. This success can only be achieved through collaboration.
Equally, they must understand that no two drug discovery and development programmes are the same — just as no two patients are the same. To provide tailored drug development solutions and bring treatments for rare disorders and diseases to market quickly, efficiently and cost-effectively, we need to understand each patient’s journey.
The patient must always come first.
This core belief, combined with our ‘perfect FIT’ approach, is why we’re more than just a CRO.
Together, we can ensure novel, life-saving therapies reach the patients who need them — faster and more effectively. Find out more about our services and how we can support you as your clinical research organisation.