USA: +1.610.230.0150
Europe: +44.330.122.0695
Central/Eastern Europe: +30.693.227.9127
Asia/Pacific: +03.2713.1956
Israel/Middle East: +972.77.693.5033

Clinical Trial Management

The InClinica team has a diverse range of experiences culled from years of work in industry and in clinical contract research organizations.

We have initiated international clinical trials (Asia, Australia, Europe, Russia, South America, and Canada), performing onsite monitoring and pre-study and site initiation, routine monitoring and close-out visits, as well as preparation of monitoring plans and supervision of clinical research associates (CRAs).

Our team has expertise in managing global budgets for studies and vendors (study sites, CROs and central labs) and managing third party vendors (subcontracted CROs, central ECG reading, IVRS’s, web portals, and central laboratories).

A few key members of our team:

Chief Medical Officer, Edward J. Brennan, Jr: 20 years’ experience in clinical research and development in industry and clinical CRO; extensive experience across all phases of clinical development, and across multiple therapeutic areas, including oncology, infectious diseases, immunology and critical care. Led teams that have filed more than 10 Investigational New Drug Applications, as well as multiple New Drug and Supplemental New Drug Applications.

Clinical Trial Manager: 19 years’ experience in global clinical operations — phases I-IV, in oncology (non-small cell lung, breast cancer, colon cancers, leukemias) and infection disease.

Clinical Trial Manager: 23 years’ experience in global clinical operations — phases I-IIIb — in oncology, transplant, vaccines, diabetes, and respiratory disease; worked in industry and in clinical CROs.

Project Director: 20 years’ experience in project management, scientific communication, program delivery and knowledge management in drug development. Expertise in clinical trial conduct, from consultation with sponsors, coordination of vendors, operations with global clinical teams, data management and scientific analysis, through marketing and communications of outcomes.

Executive Director, Project Management and Clinical Operations: 20 years’ experience in leading global clinical and regulatory efforts to submit registration packages in several diverse therapeutic areas, including oncology, analgesia, GERD, and schizophrenia, key roles in audits, operational efficiency, critical path issues/solutions, resource allocation, project management, budgeting, contract management and finance management.