Quite often the excitement of new opportunities and expansion is tempered by the limitations of existing processes, structures and resources. Realizing such opportunities demands a rapid redefinition of business processes.
A strategic portfolio review by our leading US biopharma client revealed they had a vast array of clinical development needs that were rapidly expanding. This was driven by their investments and success in the areas of immunology and immuno-oncology. It was clear a successful drug could engender clinical trials across a wide range of indications. This strategic need to foster exponential growth in new data generation demanded a rethinking of their clinical development activities and clinical trials.
However, the client’s development and medical teams were not ready. Their processes were not consistent or standardized. Additionally, internal capacity was limited and they lacked experience in externalized clinical development. Therefore, they asked a-connect to enable their move to a fully outsourced and scalable clinical trials delivery model. They needed to:
Over a twelve-week period, our team of consultants collaborated with a 10-member client team to conduct extensive diagnostics on existing activities to map all key processes. We identified responsibilities and capabilities for key internal groups across clinical development and medical. Engagement levels and governance were also defined for work with CROs, while analyzing performance data and aggregating external expert perspectives. This helped develop end-to-end process maps for future state operations.
Throughout the project, particular emphasis was placed on the anticipated expansion in post-marketing clinical trials across potential indications and immunology-based therapeutic areas.
Our team developed recommendations and a roadmap for the key clinical operations processes, with a focus on the entire post-marketing planning and delivery lifecycle. This was fully endorsed by the client leadership team which gave the go ahead for planning and action on a first wave of CRO and pilot studies. Based on the process improvements identified, a pilot program was started; our client felt confident that they could deliver three-year, 30%+ annual growth in post-marketing studies without increasing internal resources.
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