Clinical Support

Clinical Support

Our mission is to apply our in-depth experience and expertise in clinical research and development to lead our clients’ compounds and devices toward regulatory approval.

InClinica is a global clinical CRO that specializes in leading companies through clinical trials. The company was founded in 2016 through the acquisition of an existing global clinical CRO.

Our senior management team has more than a century of internal drug development experience.

We have experience in multiple diseases and device technologies, conducted across all stages of clinical trials, in North America, Asia/Pacific, Europe and Latin America.

At InClinica, the team is everything to us and, we believe, to our clients. We have recruited and retained clinical trial professionals who understand, first, the Sisyphean task of finding a compound or fabricating a device that . . . actually . . . works. These professionals are also fully cognizant of what it means to a client who has endured and developed this drug or a device.

Our General Managers – in the USA, in Europe, and in Asia-Pacific – each have 20 to 30 years’ experience in clinical development, laboratory science, commercialization of therapeutics and diagnostics, and related fields.

Showing its commitment to Quality in all of its work, InClinica hired Danielle Bradbury as its General Manager in the USA. Before joining InClinica, Dani developed her quality and compliance experience while working at Johnson & Johnson in the Quality and Compliance Department and went on to build Clinical Quality Departments for Actelion Clinical Research and BTG International Inc. where she provided quality and compliance guidance for global clinical trials. Before entering industry, Dani was a nurse working at the University of Pennsylvania in their Cardiac Intensive Care Unit and in the Cardiac Catheterization Lab. While there, she conducted sponsor- and investigator-initiated studies in drug, device and combination products. Dani’s expertise includes SOP management, inspection readiness and quality compliance. Ms. Bradbury’s therapeutic area experience includes: pulmonary, gastrointestinal, cardiovascular, and oncology.

Another major contributor of clinical and therapeutic knowledge is InClinica’s Chief Medical Officer, Edward J. Brennan, M.D. FACS. Ed possesses detailed knowledge of the clinical trial needs of biotech and pharmaceutical companies based upon years of performing clinical trials. Furthermore, he has experience as a principal investigator, providing additional value to clients. More important, Ed’s background in clinical pharmacology gained during his tenure at GlaxoSmithKline’s Center of Excellence in External Drug Discovery gave him keen insight into the discovery and development processes of small biotech companies who looked to partner with GSK. Ed was responsible for the development of multiple compounds from pre-Candidate Selection through Proof of Concept. Before joining GSK, Dr. Brennan held clinical development positions of increasing responsibility at both Johnson & Johnson and Wyeth. Dr. Brennan has extensive experience across all phases of clinical development, and across multiple therapeutic areas, including oncology, infectious diseases, immunology and critical care. He has led teams that have filed more than 10 Investigational New Drug Applications, as well as multiple New Drug and Supplemental New Drug Applications.

InClinica is a well-rounded clinical CRO with experience of executing clinical trials in many different therapeutic areas. Our regulatory advisors have held positions in the FDA and EMA, have worked in industry, and can provide strong strategic regulatory guidance to early stage programs in drugs or devices