Case Studies

Filtered by Client: Medical Devices

ARO Organizational Gap Analysis Situation: A multibillion dollar medical device company was seeking to accelerate their time to market in both the United States and Europe.  The product was a class II device in the US requiring clinical trials. Solutions: Halloran developed a regulatory strategy ... 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 ... Clinical Process Roadmap For A Global Operations Group Situation: A global medical device company with clinical operations staff in multiple locations that had grown through acquisitions wanted to harmonize their SOPs into a single repository of global SOPs. They wanted a mechanism to organize the procedures into a useful job ... Clinical Strategy Development and Leadership Support Situation: A mid-sized medical device company focused on developing class II surgical products needed assistance in developing clinical strategies for a number of products in their pipeline. The company also needed an interim Clinical Director to help build the clinical ... Clinical Strategy for Growing Device Portfolio Situation: Division of large medical device company with no clinical capabilities needed to develop a post-market clinical strategy for several key product lines. Solutions: Interviews with divisional and corporate stakeholder groups provided an understanding of objectives ... Expertise in Ethics and Study Conduct On-Demand Situation: A virtual start-up diagnostics company desperately needed clinical expertise to get a program up and running coincident with a fundraising effort. Halloran was asked to put someone in an operating role with the start up because precious time was being lost; the ... Gaps in Senior Leadership Situation: Halloran was asked to conduct a Gap Analysis on a Phase 3 clinical study for a biotech company.  The trial was 12 months old and already running six months behind schedule on site activation and patient recruitment.  Solutions: Halloran utilized a team ... Global Program Steered Back On Track Situation: During a Vendor Management training program conducted by Halloran, additional issues were brought to the forefront by the participants. The company was in crisis at a critical time with a major global trial starting and alarming turnover within the clinical ... Global Strategy For Reclassified Device Situation: Mid-sized, established medical device company needed to develop a post-market surveillance program in response to public health questions posed by FDA. Solutions: Halloran developed responses for FDA that allowed the company to respond to safety and efficacy ... Integrating Clinical Operations at a Major Medical Device Company Situation: A large, diversified medical device company had grown a division through acquisitions over a number of years without integrating clinical organizations. Solutions: An organizational and quality system assessment of the various clinical groups revealed ... New Entrant into the Medical Device Arena Situation: A global industrial products company with a Class II device for hospital emergency departments needed help with vendor selection for an economic study to support hospital purchasing decisions. Solutions: Halloran identified qualified CROs, managed the RFP ... Quality System Optimization For An Industry Leader Situation: Halloran completed a quality systems gap analysis for a large, global medical device/pharmaceutical company which identified a number of areas for compliance remediation. Halloran implemented an extensive remediation plan that included process re-design, SOP ... 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 ... Regulatory Due Diligence and Clinical Strategy Development Situation: A large medical device company needed help with regulatory and clinical due diligence to effectively position itself for decisions on a target technology acquisition. Solutions: Based on Halloran's competitive intelligence in the therapeutic area, the market, ... Regulatory Strategy and Risk Benefit Analysis Situation: A multibillion dollar medical device company was seeking to accelerate their time to market in both the United States and Europe.  The product was a class II device in the US requiring clinical trials. Solutions: Halloran developed a regulatory strategy ... Regulatory Surveillance via Quarterly Newsletter Situation: Large global medical device company with a diverse pipeline ranging from surgical products to radiopharmaceuticals had a communication gap within a particular business unit. Clinical Operations had difficulty staying abreast of evolving medical device regulatory space ... Starting Off On the Right Foot Situation: Venture capital seeded start-up biotech with novel therapeutic modality sought to identify possible first targets based on scientific and clinical development criteria. Solutions: Halloran attended launch meetings with the entrepreneurs and investors to flesh out ... Systems Implementation Situation:  The clinical division of a large medical device company with 10+ global locations and 50+ active clinical trials chartered an enterprise-wide systems initiative to automate and optimize processes for data collection/management, safety event processing, site ... 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: ...