Leading Biotech Company

The Client

One of the largest and leading biotech companies with over 91,000 employees worldwide with a focus on research, development, manufacturing, and marketing of drug products used in treating serious or life-threatening medical conditions.
 

 

The Challenge

The client established a mandate to add efficiency and oversight into its global dossier submission process. The mandate identified several performance indicators that were to be impacted by this project. These included the reduced time between submissions, increased visibility into active submissions, and improved efficiency in authoring documentation.

The client’s solution was to develop a custom global system to streamline the process of submitting dossiers to health authorities for approval. A solution was developed to support dossier planning, authoring, and submission activities, in addition to enabling users to be more efficient when responding to country-specific regulatory changes. The new global system solution would affect over 10,000 submissions in over 120 countries annually.

Abilaire's Solution

The client commissioned Abilaire to provide performance analyses and develop a performance support strategy that would effectively train and support users in a global environment and identify how it enables their submission processes. The solution impacted over 1200 users, in over 20 countries, each with variable needs in the system, and variable experience in the processes.

Performance Analysis

Abilaire conducted a series of performance and change analyses impacting a global audience, and consisting of a comprehensive front-end analysis, organizational change impact analysis, change resilience assessment and a hierarchical task analysis. The analyses resulted in the mapping of process tasks to enable system steps, identification of potential gaps, recommendations for risk mitigation during implementation and sustainment, and an end-to-end learning and performance support strategy.

Solution Proposal

Abilaire developed a learning solution that addressed all five performance moments of need. Abilaires’ proposed solution recommended and ultimately implemented a blended learning approach comprised of pre-and post-learning activities consisting of elearning, classroom training, micro-learning, electronic performance support, training sustainment strategies, and static performance support tools.

Implementation

Using systematic analyses, Abilaire provided the right solution to the right stakeholder at the right time. All while developing checkpoints built into the process to allow for formative evaluation to ensure the developing solution continued to “Meet the Need” and identify post implementation checkpoints to embed a continuous improvement mindset into the product.

Measurement

On account of Abilaire’s performance and responsibility based training, and performance support solutions, the client was able to establish measurable baseline metrics. These baseline metrics allowed the client to measure the impact of the developed solutions against the core Key performance indicators. All while addressing the ultimate need of the learners to have a End to End awareness and comprehensive training on the client’s submission process and the System functionality that enables it.

Abilaire in partnership with the Client developed a programmatic training strategy that is driving sustainable competency in the system, but more importantly in the client's internal processes.

Solutions Applied

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