Pharmacovigilance services for rare conditions and diseases

We provide proactive pharmacovigilance solutions for the routine and ad hoc monitoring of the safety of your product, whilst ensuring your regulatory compliance — from the first moment it’s given to a patient and throughout its life cycle.

For rare diseases, monitoring the safety profile of a drug is more complex due to the challenging nature of the underlying disease characteristics, a much smaller patient population from which to develop research expertise, and a limited understanding of the natural history of the disease in the medical community. Our integrated approach enables us to adapt to the unique requirements of clinical studies in this area — looking at current implications and identifying safety signals early, but also anticipating future challenges in the drug development process — to support the long-term success of your product.

At TMC, we will guide you, as your partner, through every stage of drug development. We’ll use our expertise in the intricacies of pharmacovigilance for rare diseases to help you navigate challenges and ensure the safety and efficacy of your products — from early drug development to post-marketing activities.

At the heart of our pharmacovigilance services is our mission — indeed our passion — to support drug development solutions that improve patients’ lives. By working with TMC, you can benefit from our deep understanding of the intricacies of safety monitoring requirements for rare disorders and diseases, ensuring patient safety and regulatory compliance throughout the drug development process.

Comprehensive safety monitoring and risk management plans

As a specialist clinical research organisation, we have extensive experience providing pharmacovigilance services for rare diseases — particularly across our key therapeutic areas of oncology, neurological disorders, respiratory diseases, haematology, ophthalmological conditions, neonatology, hepatology and nephrology diseases.

Our expertise in these fields allows us to support drug development solutions that consider the nuances of clinical studies for rare diseases. We can advise on the careful balance between the benefit to the patient and the risks a therapy could potentially pose, helping you build a robust safety profile to ensure a seamless transition through the various stages of drug development.

At TMC, our services cover the entire drug development process, including developing integrated risk management plans and comprehensive signal management programmes that link safety data with clinical outcomes to identify and address safety signals early. We can also assist with the creation and maintenance of compliant pharmacovigilance system master files and safety reporting documentation. Our team is skilled at processing adverse events and serious adverse events, with thorough analysis and reporting across all regulatory territories.

The perfect FIT for pharmacovigilance

We help you bring innovative therapies to patients with rare disorders and diseases — safely and efficiently — through our flexible, integrated and tailored services.

Flexible model

We’ve developed a close bond with our global network of trusted and highly skilled associates, enabling us to adapt our business model to ensure the swift and cost-effective deployment of resources. Our services are tailored to meet the specific requirements of your drug’s life cycle and region, from early clinical studies to post-marketing safety monitoring. We adapt to your project’s needs, providing scalable pharmacovigilance support across global markets.

Integrated approach

From the moment a patient first receives a drug in a clinical study and even after it’s licensed, safety monitoring is critical. Collaboration is essential throughout the drug life cycle to develop integrated risk management plans, signal management programmes and effectively process adverse events or serious adverse events. That’s why our people are your people. We support you at every stage of your drug development journey, working closely with our medical, clinical and regulatory teams to prioritise patient safety.

Tailored solutions

No two drug discovery and development programmes are the same — just as no two patients are the same. Our extensive experience in good pharmacovigilance practices and rare diseases allows us to understand the complexities of safety monitoring requirements in this area and explore creative and effective solutions that improve patient outcomes whilst ensuring safety and regulatory compliance.

Get In Touch

Together, we can develop novel therapies that are both safe and effective, ultimately improving the lives of patients with rare diseases. Email our team today or contact us below to discuss how we can support your pharmacovigilance needs and help you navigate the complex landscape of drug safety monitoring and compliance for rare conditions and diseases.