At InClinica, we empower our employees. We believe in their strengths, equip them with the tools to tackle any challenge and foster continued growth at all levels within the company. Here is just a handful of our many individual stories of accomplishment.
Although I have worked at several pharmaceutical, biotech, and CRO companies over the last 24 years, I feel that I had the greatest impact during my work in a development program for a transplant drug.
I worked on this program for 10 years, managing studies during phases I-III and helping to finalize the clinical development program. When I first started working on the program, I was managing a dose-ascending, phase I safety study. We progressed into phase II, where I had the opportunity to work with various US investigators, who were quite excited about this Proof of Concept study. The study met its endpoint, and we proceeded into phase III. I was assigned management of the pivotal global phase III study which showed the efficacy and safety of the compound in kidney transplant patients. I initiated sites globally, conducted investigator meetings and met study timelines. I participated in the preparation of the NDA, as well as the FDA Advisory Board meetings. The result was FDA and EU approval of the product. I felt that my contribution to the program, including management of multiple vendors and transplant sites around the globe, contributed to the approval of this product and ultimately made a difference in the quality of life for patients living with a transplanted kidney. — Global Clinical Trial Manager
I had one of those projects once that weren’t the typical “bread and butter” of a clinical CRO. I had to educate a Sponsors medical liaison team about a disease, its prevalence, and the relevance of the Sponsor’s compound to the disease. I had to internalize the results of a large epidemiologic study and then spearhead the development of a trial overview presentation and extensively train the team on critical elements of the study (patient inclusion/exclusion criteria, laboratory levels and patient-reported symptoms. The presentation provided valuable data for the medical liaison reps to highlight appropriate patient selection for the compound in clinical practice. The Director at the sponsor company told me the clinical team gained important insight into the prevalence of disease and selection criteria to help physicians identify patients who would benefit optimally from therapy. — Project Management Director
I was involved in the successful re-start of a U.S. juvenile diabetes III program. About 330 patients needed to be enrolled in a study to compare whether the vaccine would preserve the body’s own insulin-producing capacity in patients recently diagnosed with type 1 diabetes.
I helped develop the critical strategies required to drive site enthusiasm and patient enrollment. We expanded the site list to include academic research hospitals; educated site staff on therapeutic benefit; streamlined the process for collecting multiple consent forms per patient (overall, 452 ICF consents); empowered study coordinators; and created patient-friendly study in-take processes.
At the end of a two-day audit meeting, the client complimented the project team on our work. — Global Clinical Trial Manager