Brizzey Turns 3 (and a bit)

Brizzey turned three in February and it’s fair to say that time has flown.  Since our last communication, we’ve continued to work hard within our mission and vision, supporting existing and new clients in their important drug development endeavors and we wanted to share some of what we’ve been up to.

If anything here resonates with a problem you’re facing or with an opportunity with which you could use some help, we would be glad to hear from you.  [email protected]​
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Process, Systems and Tools

• Process development and architecture continues to be a cornerstone of our business and not just within clinical supplies.  Last year we worked with a Clinical Operations group to develop their process architecture, a baseline process model and associated modelling standards. 
• We helped a medium sized company develop a risk assessment and contingency planning process for their clinical supply chain.
• We’ve worked with a small client to develop the framework for them to gather country-specific data on regulatory and import requirements.
• We’re currently working with a client to help them develop phase-appropriate GMP requirements.
• We’ve worked with a client to develop an alternate source for a difficult to blind comparator product class.
• We developed a clinical supply planning template and associated business rules for a small sponsor company.
• We’ve worked with a service provider to help them address a number of Quality System related process improvements.
• We are working with a clinical supply group to develop a high-level, interactive, end to end process map, with links to tools, RACIs, templates and training. 
• We have worked with a small client to improve their operational processes, Site Master File and Quality Manual.
• We’ve worked with a client to conduct risk assessment and mitigation planning for their cold chain storage facilities.
• We have conducted surveys of the industry on behalf of a number of companies to determine what IT based clinical supply inventory management systems are in use, available commercially and best suited to their needs.
• We have assisted a small client specify and implement a commercially available clinical supply forecasting and inventory management system.

People and Partnership

• We’re proud to have developed a comprehensive, multiple module training program, adaptable to an on-line or in-person training environment (we prefer the latter), designed to give new and seasoned clinical supply professionals a solid grounding in the pharmaceutical industry, drug development, clinical study design and execution, import/export and risk assessment and mitigation.  All our modules can be tailored to specific client needs and learning environments. 
• The unique perspective we’ve gained, having worked both independently and, in the past, for sponsor companies, has enabled us to help several clients to manage the essential partnership between these two entities in order to sustain successful clinical trials.
• We’ve been able to use our observations on the characteristics of different types and sizes of sponsors and how these characteristics influence their approach to clinical supplies into training materials, which will benefit both CMOs/CROs and sponsor companies going through or anticipating a merger.
• We helped a medium sized company to establish clinical supply group objectives and, in conjunction with our strategic partner, Crux Move Consulting, to carry out Team Development activities.
• We worked with a sponsor and service provider to identify and develop a set of proposals on areas for improvement for their relationship.

Strategy & Planning

• ​We continue to support several small pharmaceutical and biotech companies as they prepare for and execute their first clinical trials.
• We investigated current approaches to Compassionate Use Studies and Investigator Sponsored Studies for a small sponsor.
• We are currently helping a company prepare themselves in case of a merger.

For more information on any of our services, please drop us a line:

[email protected]