Case Studies

Filtered by Service: Organizational Design and Development

An NDA and IPO Tied Together Situation: A small biotech company licensed a compound approved in Japan.  The compound had previously been subject of clinical and pre-clinical development in the United States and Europe over a period of nearly 10 years.   The client's internal resources were ... 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 ... Critical Outsourced Program Has Skill Gaps Situation: Risks were identified around quality of data and cost/timeline management by the management of an early stage vaccine company. Their in-house team did not have the capabilities to adequately manage outsourced programs. Solutions: Halloran created and delivered a ... 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 ... 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 ... Midstream Leadership with Virtual Development Mandate Situation: New leadership joined a commercial stage company after shareholders rejected a strategic acquisition to augment their limited pipeline. The development organization had been formed under the assumption that it would be a fully integrated pharmaceutical company and now ... Multi-Year On-Demand Clinical Development Expertise Situation: An emerging specialty biopharma company in rapid acquisition mode had skill gaps at several levels over a multi-year period, including senior clinical leadership, outcomes research, and clinical quality assurance positions. Solutions: Interim leadership of ... 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 ... Training the Whole Team Situation: A growing global specialty biotechnology company needed external expertise to enhance corporate training initiatives for employees on all aspects of product development. Solutions: Over a multi-year period, short courses were developed and delivered on a regular ...