Experience covering numerous Orphan and Ultra Orphan indications; specialist knowledge in complex registration programmes with limited data.
Our knowledge includes Inborn Errors of Metabolism, rare Oncology and Haematology conditions and inherited neurodegenerative conditions.
Design and conduct of post-marketing studies and registries to augment pre-registration data and meet regulatory commitments.
Haematology & Oncology
Knowledge covering all mechanisms including targeted therapy, immunotherapy, companion diagnostics, cancer vaccines and novel cytotoxics.
Clinical experience in numerous solid tumor and hematological malignancies, including epidemiology, pathogenesis, diagnosis, prognosis, biomarkers, standard of care treatment, and investigational therapies.
Broad experience with a wide range of non-malignant hematologic disorders involving red cells, white blood cells, platelets, and coagulation factors. Expertise managing complex oncology and hematology trials in Phase I-IV.
Experience covering all phases of Cardiovascular, Diabetes, Gastroenterology and Immunology drug development, including numerous successful MAAs.
Clinical experience in cardiovascular and diabetes including epidemiology, pathogenesis, mega trials, endpoint driven trials, standard of care treatment, and investigational therapies.
Proven successes in late phase Immunology and Gastroenterology development.
Immunology & Infectious Diseases
Knowledge covering broad range of Infectious Diseases, including HIV, hepatitis B and C, pneumonia, skin infections, cystic fibrosis and septicemia.
Clinical experience with agents including antibacterials, antifungals and antivirals. Specialist knowledge in complex combination therapy studies and registration programmes.
Advanced Therapeutic Medicinal Products (ATMPs)
Recent experience with ATMPs, including adult and embryonic stem cells.
Working to develop submission strategies for this class of therapies in the US and the EU.
Strategic insight into design and development of CNS trials including use of biomarkers.
Direct experience of major submissions in multiple CNS areas, including Alzheimers, Depression, Schizophrenia, Anxiety and Insomnia.
Urology and Gastroenterology
Clinical development insights from both small molecule and biologics development plans in IBS, pancreatitis, Crohn’s Disease and Ulcerative Colitis.
Major submission and common technical dossier development across multiple GI and Urology indications including constipation, renal failure and pancreatitis.
Recent experience in rare, genetic, age-related and degenerative ophthalmologic conditions with both EMA and FDA.
Strategic support to Ophthalmology products undergoing scientific advice procedure in both US and EU simultaneously.
Experience in developing Paediatric Investigational Plans (PIPs) to support EU registration strategies.
Including the conduct of PIP compliance checks, and submission of paediatric waivers, deferrals and modifications.
Contact us today to discuss your project – call +44 (0) 1494 957366