At LS-SACS, we believe that customizing best practices in traditional business consulting methods, processes and tools is critical to drive transformation of individual functions  of the life sciences industry.  

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We are aware of the various functional challenges and opportunities and have developed specialty focus on selected functional areas - Clinical operations, pharmacovigilance & patient safety, regulatory affairs, medical affairs, procurement & strategic sourcing and commercial operations.  ​

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Context:

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Clinical Operations - Several new approaches (e.g., Digital Clinical Trials - DCT) have created exciting opportunities to rapidly meet the unmet needs of patients.  There are several factors that challenge the industry’s efforts to conduct faster trials and getting approval of the products.  These include complex trial protocols, design and implementation of new operating models, increased (and evolving) global / regional regulations and number of trials, limited availability of patients and increased cost.  

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Pharmacovigilance / Safety:  As the pharmaceutical industry expands its portfolio of products (e.g., Cell Therapy, Gene Therapy) and global reach, they are also shifting their focus from being “reactive” and push towards a “proactive patient safety” culture, processes, and technologies.  They have to transform their global PV operations to become nimble and improve their ability to manage varying global case volumes effectively for improved compliance. 

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Regulatory Affairs:  As clinical trials expand globally to meet unmet needs and diverse patient populations, the role of regulatory affairs is increasingly key to both commercial success and growth.  E2E product lifecycle management leveraging regulatory intelligence to operations and analytics is critical to success.  Regulatory operations are striving to deliver “First time right” quality and “zero compliance errors”. 

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Clinical Data Sciences:  Clinical Data Management (CDM), Biostatistics and Statistical Programming are critical for ensuring that the most accurate data from clinical trials are processed and shared with decision makers in as close to real time as possible.  AI is making it much easier data scientists to perform their tasks from data cleaning to predictive modeling to adaptive trial design & Central Monitoring and is driving the changes across process, people / roles and technology.  This would require changes in the operating model and how data scientists will collaborate with other parts of clinical operations in the future.  

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Services​

 

LS-SACS has customized best practice services in validating, redesigning operating models, processes, staff roles / training, and leveraging digital technologies to meet the changing needs of of life sciences organizations:   ​

• Redesign the future operating models (TOM) in clinical, safety, regulatory or other areas using a combination of internal capabilities and partners / alliances, digital / AI technologies and people skills.

• An OCM strategy that is customized to meet the digital and other transformation initiatives across clinical, safety, procurement, regulatory, commercial and other functions.

• An effective communications approach that is aligned with the change management plans and the specific needs of the client and their stakeholders / customers. 

• A razor focused approach that leverages industry experts "on demand" to ensure delivery of the transformation initiatives' expected outcomes.