Case Studies

Filtered by Service: Gap Analysis

Clinical Operations Best Practices Situation: Established biotech company with a small pipeline of novel products was at a key juncture and wanted to position itself for actionable reflection on its clinical operations using an independent assessment. Solutions: Halloran conducted a gap analysis on ... Growing Company Needs Operational Infrastructure SItuation: Company with targeted therapies in all stages of clinical development in oncology. Operational strategy was to scale capabilities to manage development programs in-house in preparation for an initial public offering. There were scientists and physicians on board but ... Interim Project Management Support and Clinical Quality System Gap Analysis Situation: A small biotech company, with a novel technology to develop, produce, and commercialize therapeutic proteins, was embarking on a global Phase 2-3 clinical program and was in need of a strong project manager for three global clinical trials, including vendor selection ... Phase 3 Readiness Situation:  A mid-sized pharmaceutical company preparing to begin a global, pivotal clinical program for their key product needed an assessment of organizational compliance and readiness. The program was highly complex with >10 vendors and over 100 sites in 12 countries. ... Quality Systems Gap Analysis and Remediation for a Medical Device Leader Situation: A market leading medical device company with a robust pipeline of Class II and III surgical devices recognized challenges in quality and delivery in their clinical organization and requested an organization-wide gap analysis. Solutions: Halloran conducted ... Submission Readiness Evaluation Situation: Established biotech company was filing its first NDA with new clinical and biostatics leadership after a five-year pivotal study. Company was concerned with compliance "drift" over the course of the study and sought external review and critique of clinical systems, ... TMF Inspection Readiness Strategy Needed for Pivotal Clinical Trials Situation: A large biopharmaceutical company with pivotal clinical trials underway required strategic support and a unified approach to ensure trial master file (TMF) quality while safeguarding inspection readiness of pivotal trial documentation. Solutions: Halloran conducted a ... Training the Right People to Do the Right Work Situation: A global healthcare company specializing in medical imaging and diagnostics asked Halloran to assess whether their training curriculum was sufficient to build relevant skills for implementing scientifically sound and compliant clinical research. Solutions: ...