Global Oncology Phase 3 Rescue Study
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Medical Affairs
Our highly experienced global Medical Affairs Team provide world-leading expert medical services to support clinical development and Early Access Programs.
Our highly experienced global Medical Affairs Team provide world-leading expert medical services to support clinical development and Early Access Programs.
We have a highly experienced global Medical Affairs Team providing expert Clinical Development, Early Access Program (EAP) and Pharmacovigilance medical support. We are involved in a wide range of Phase 1-4 Clinical Trials and Early Access Programs and our in-house services include:
‘We provide world-leading expert medical services to support clinical development and Early Access Programs.’
Our experienced Medical Affairs Team provide important input to the design, feasibility, site/PI selection and delivery of a wide range of Phase 1-4 Clinical Trial and RWD protocols. In addition, they provide highly experienced global 24/7 Medical Monitoring and Medical Pharmacovigilance support covering Phase 1-4 studies, in a broad range of disease areas, with a high level of expertise in oncology/heme-oncology, respiratory, neurology, infectious diseases and rare diseases.
Patient safety is our priority, and our broad Medical Pharmacovigilance experience includes regular review of all safety and PD data arising in Clinical Trials and EAPs, signal detection and management, medical review of ICSRs including SUSARs, and associated regulatory documents including RMPs, PSURs and DSURs.
We also offer strategic expert medical advice and consultancy, including major contributions to clinical development plans, regulatory SA documents and meetings, clinical protocols, IBs, ICFs, SAPs, CSRs, white papers and regulatory and ethics submissions.
We have extensive, world-leading experience in setting up and supporting global Early Access Programs for patients with a wide range of diseases, particularly in oncology/heme-oncology, rare disease, respiratory, neurology and infectious diseases.
We work closely with our client medical teams to support the development and definition of the initial EAP strategy and need, medical training on the programs, and the development of the upfront Medical Approval Plan and Eligibility Criteria, in order to provide compliant, ethical, and safe medical approval, advice and escalation processes on all physician-patient requests.