Case Studies

Filtered by Service: On-Demand Expertise / Interim Support

Biotech Meets Big Pharma Situation: A biotech company licensed their product currently midstream in development to a big pharma company. The two groups had very different approaches and decision and action speeds in product development.   Solutions: Halloran worked as an intermediary ... Clinical Monitoring Oversight ToolKit Situation: A biotech company elected to outsource their clinical study monitoring.  As a result, the company needed a toolkit for internal use to evaluate and monitor the quality of the outsourced monitoring effort.  Solutions:Halloran developed a Clinical Monitoring ... Clinical Project Management Situation: An innovative life science company with a focus on improving fertility outcomes for women through a modified IVF procedure required expertise and guidance to initiate their first clinical program.  The venture included designing, implementing, and managing the ... 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 ... Electrical Impedance Myography Trial Situation: A virtual operating company in partnership with a patient association focused on a rare pediatric disease identified a promising technology for use in measuring muscle health. The organization wanted to run a clinical trial to compare the technology to standard ... From Bankruptcy to a Deal Situation: A cash-constrained pharmaceutical company, which spent $360MM on two products, sold its later stage Phase 2 asset to a virtual NewCo for development. The asset needed to continue being developed without interruption. Solutions: A Halloran project manager was ... 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 ... 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 ... Navigating Conversion From Paper to e-Diary Situation: Specialized division within large, global pharmaceutical company with innovative preventative medicine pipeline, with strategic initiative to move from capturing subject diary data on paper, to capturing this information directly into electronic form via ... 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 ... On-Demand Development Team Situation: Small virtual biotech with transdermal delivery system and no experience in the drug development process. Solutions: Gap analysis revealed no experience in drug development and approval and limited understanding of expectations . No vendor management competency ... Part Of The Team Situation: Lean biopharma led by expert industry executives with a promising discovery pipeline was in need of a critical path to rapidly select a development candidate in a neurological indication. Solutions: Halloran provided interim project management to help both with ... Preemptive Training to Mitigate Compliance Risks Situation: A global pharmaceutical company acquired a small biotech company with a novel product for seriously ill liquid tumor patients. Upon post-acquisition due diligence, the compliance issues identified in the mid-stream proof of concept trials were alarming, and the ... 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 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 ... 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 ...