Life Sciences industry is at the throes of innovation and transformation.  Targeted therapeutic approaches for cancer and rare diseases and rapidly evolving genomics and molecular medicine approaches are translating into Precision medicine and individualized therapeutic protocols. Gene therapy and Gene editing are beginning to transform the industry at a fundamental level. Decentralized Clinical Trials (DCT) are aiding the transformation, facilitating a patient-centric approach and leveraging a variety of digital technologies.  Recent application of mRNA-based platforms, expeditious trials and submission have led to the approval of highly effective vaccines for COVID-19.  These new approaches provide increased confidence to the life sciences industry and the patient population in the potential of next generation treatments. 

 

Multiple operational levers are being evaluated, leveraging "Digital Clinical" infrastructure and associated processes and trained staff and applied to increase the efficiency of clinical trials: 

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• ​Adaptive designs, patient-centric and Real-World Evidence (RWE) based.

• Operational agility to conduct decentralized clinical trials (DCT), remote monitoring of sites, remote patient engagement and leveraging a variety of digital technologies (e.g., m-Health devices).  

• Define and implement better data standards and deliver improved data quality.

• Establish "Best In Class" governance to enable sharing of real time insights across functions internally and externally (e.g., CROs, regulators and other industry peers) to drive better collaboration and improved outcomes for patients.

• Ensure enterprise-wide adoption of digital, AI, machine learning and cloud technologies to accelerate time to market and achieve real transformation  

 

As industry pursues a diverse set of global and submissions, there is added pressure on Pharmacovigilance, Regulatory affairs and other functions to improve their operational agility, digital technology capabilities and understanding regional regulatory agencies' requirements for successful submissions.  Hence the need for business transformation and a dependable set of external providers that offer scalable, flexible and high quality services for a variety of “Future-ready” operating models has become a critical. 

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LS-SACS approach to assisting clients in their Transformation efforts

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Life Sciences Sourcing Advisory and Consultancy Services (LS-SACS) is committed to assisting and driving the transformation of the industry.  We offer advisory and consulting services in two main areas of transformation in the industry - Clinical operations transformation and Strategic Sourcing and Outsourcing.   Our proven approach will enable our clients to become more efficient, reduce clinical development cycle time and cost of operations, while ensuring highest quality, patient safety and satisfaction. 

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• ​Strategic Sourcing / Outsourcing Advisory Services:  We provide "end to end" sourcing services from strategy through RFP process followed by post contract implementation and governance. We ensure established contracts and agreements with the optimal set of global and regional CRO, FSP and Technology vendors that fits your needs. Service areas include  

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• • Clinical monitoring / operations

  • Clinical data services (e.g., CDM, Biostatistics / programming, data standards / conversions)

  • PV / drug safety

  • Complaints management 

  • Regulatory affairs

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• Business Transformation across Clinical, Pharmacovigilance and Regulatory Operations: We bring proven frameworks, experience, and expertise to help you define your clinical, PV or regulatory operations future vision that is aligned with industry trends.  We help redesign internal processes and align technologies. We assist in refining the skills and redesign of the roles and responsibilities of staff across clinical operations, clinical data services, pharmacovigilance, regulatory affairs and other areas. 

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We bring the Ideal combination of strategic sourcing experience with all types of engagement models and the diverse domain / functional expertise needed to enable transformation.