Conduct seamless early-phase clinical trials for advanced therapeutics
Greater regulatory support, the growth of patient advocacy groups, and the implementation of hybrid approaches are all making clinical studies significantly more accessible to patients with rare diseases, including rare oncology diseases. However, conventional clinical study protocols don't always apply to rare disease clinical trials, and limited patient populations make recruiting and retaining patients difficult.
TMC Clinical specialises in early-phase clinical trials and full-service clinical development solutions for rare disease, complex oncology and advanced therapeutic modalities. We combine the responsiveness of a specialist pharma services company with the expertise of a clinical research organisation, enabling biotech and pharma companies in Phases 1–3 to accelerate timelines, reduce risk and confidently secure new drug approvals.
Our clinical development services provide complete support across early-phase clinical trials — from site feasibility, key opinion leader identification and submitting your clinical trial application for first-in-human pivotal studies to ongoing site management, medical monitoring and reporting to relevant regulatory agency gateways.
Specialist support for Phase 1–3 clinical studies
Extensive experience in complex indications
Rare diseases affect less than 65 per 100,000 people (source: The World Health Organization). These people are often overlooked as smaller patient populations create momentous challenges in the design and execution of clinical studies for advanced therapeutics. As a result, there's a significant gap when it comes to research and clinical trials for rare diseases.
We understand these innate challenges and have extensive experience in:
- Full-service, first-in-human through to global pivotal studies.
- Complex trial design in oncology and rare diseases.
- Advanced therapeutic modalities, including but not limited to cell and gene therapies (CGT), biologics, RNA-based therapeutics, and oncolytic viruses and other novel immuno-oncology platforms.
Using our knowledge and clinical expertise, we ensure the successful clinical development of your product, including clinical trial study design, overseeing data integrity and managing patient recruitment. We always ensure the clinical study protocol is aligned with patients, incorporating both on-site and decentralised clinical trial elements to improve patient access, recruitment and retention in these difficult-to-reach communities.
Find out more about designing and conducting effective rare disease clinical trials.