Management Consulting Services
"I worked with Krishnan on a couple of programs where we implemented AI based technology solutions in the clinical trials space. He was an excellent partner who genuinely fostered a collaborative atmosphere. He and his team went the extra mile in helping us tailor the solution to our needs and implemented cutting edge technologies to create data visualization tools. Krishnan had a keen interest in this area and will be of great help to health care companies looking to move into time data visualization and analysis of clinical trial data" - Dr. Niranjan Rao, Senior Vice President, Development Sciences at Asana Biosciences, LLC.
Management Consultancy Services
For Life Sciences Clients:
We bring proven consulting and transformation frameworks, experience, and expertise that are customized to Life Sciences clients across Clinical Operations, CDM, Biostatistics and Programming, Pharmacovigilance, Regulatory Affairs and other areas.
We help you transition to the "Best In Class" Target Operating Model through structured, seamless and timely implementation plans. We assist in redesigning internal processes, technologies and tools (e.g., Digital, Automation, AI / ML), while ensuring the redefined roles and responsibilities, training and Organizational Change and Communications (OCM) are integrated into the plan.
We collaborate seamlessly with your leadership and operational teams in helping you achieve the desired outcomes (e.g., quality & compliance, productivity, cycle times, customer satisfaction and cost) in a timely manner
For Service Providers and Investors:
We assist Life Sciences Technology product companies in the review, competitive positioning, and Go To Market approach of their product portfolio and business model.
We also assist PE and other investment companies in their evaluation of potential investment opportunities across Healthcare / Life Science Tech companies, CRO, BPO, and IT services, in the context of current and future industry trends, competitive positioning and growth potential
Life Sciences industry is undergoing real transformation that was further propelled by COVID-19 pandemic over the past couple of years. The increased collaboration between Pharma and biotech, governments, payers, providers / health systems, service providers and retail pharmacies is driving innovation and increased benefits to patients. Digital health, telemedicine, and virtual trials / DCT along with virtual / work anywhere environment is pushing life sciences companies to ensure highly efficient operations and collaboration and increased productivity.
LS-SACS is prepared to assist life sciences clients in their preparedness to meet the challenges and opportunities of the transformation journey with a targeted set of consulting offerings. We believe that these offerings will meet the most critical needs of the industry either on a stand-alone or as a combined End-to-End solution. We are committed to delivering improved outcomes across customer satisfaction, quality, safety, time to market and cost, while helping our clients progress through the transformation journey seamlessly.
Our Core Consulting Offerings include:
Business / Functional Strategy Development
Business Operations and Performance
People & Organizational Change / Communications
Technology Strategy (Digital, AI / ML)
Transformation roadmap Implementation, Metrics Tracking and Measurement
LS-SACS' has leveraged best practices frameworks, tools and methodologies and customized them to Clinical Operations, Clinical Data Services, Pharmacovigilance, Regulatory Affairs and other areas:
Decentralized Clinical Trials (DCT) are aiding the Life Sciences industry transformation, facilitating a patient-centric approach and the adoption of variety of digital technologies. Multiple operational models and levers are being evaluated and applied to increase the efficiency of clinical trials: While these new approaches have created exciting opportunities for meeting the unmet needs of patients, there are several factors that challenge the industry’ 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. The establishment of global vendor(s) / partner(s) is a critical component that would complement industry efforts
LS-SACS' proven transformation frameworks, network of experts and collaborative approach is designed to assist clients in evaluating their current processes and technologies, map them against their future vision and industry best practices / trends, identify gaps and develop a tangible plan to close the gaps and establish a robust clinical transformation roadmap and key milestones
Pharmacovigilance / Patient Safety
As the pharmaceutical industry expands its portfolio of products and global reach, their Pharmacovigilance functions must keep up with product innovation, advances in technology, and changing regulatory requirements while at the same time delivering on their risk management responsibilities in a reduced budgetary environment. Life Sciences companies have been 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.
LS-SACS partners with clients to establish a globally integrated 24x7 operating model, delineation of core Vs non-core activities, identification of long-term partners and selecting / optimizing digital technology platforms and tools to streamline their operations for proactive quality, safety, compliance, cycle time and cost.
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”
LS-SACS assists clients in their efforts to move to a “one team” approach with centralized regulatory policy, while ensuring local flexibility, globally harmonized processes and governance and a flexible Regulatory Information Management (RIM) system, dashboards and decision-making in a collaborative mode and with the right team of experts.
LS-SACS APPROACH TO BUSINESS TRANSFORMATION CONSULTING PROJECTS
Key activities and deliverables as part of our Business Transformation consulting projects
Define and implement "To Be" operating models and achieve transformational objectives such as Patient Centricity (e.g., Decentralized Clinical Trials, Virtual / Central monitoring), "Proactive pharmacovigilance / patient safety", and "First time right" regulatory submissions.
Ensure alignment of clinical, PV and regulatory operations objectives and metrics with overall R&D and clinical development strategy (e.g., Balanced Score Card)
Leverage proven Business Process Mapping and Reengineering (BPM / BPR) to design a future state vision that is aligned with industry trends, complete gap analysis and develop a practical implementation roadmap with clearly outlined milestones
Recommend the "best fit" digital technology platforms and data / information flows that can seamlessly align with the client's clinical, PV, regulatory strategy objectives and desired outcomes
Design and implementation of organizational change and communications (OCM) plan that is seamlessly aligned with the program plan, timelines, and milestones.
Review of key roles and responsibilities of client staff required to fit the future operating model and develop a practical plan to close the gaps through training, retraining and recruiting.
Establish global and regional service (CRO, FSP) and technology partners who will complement internal skills, capabilities, and expertise in a scalable and flexile manner.
Leverage proven frameworks, templates, and expert network of expert industry experts / consultants to ensure cost effective. high quality, and timely deliverables in a collaborative manner
Business transformation service areas include Clinical Operations, Clinical Data Management, Biostatistics and programming, Medical Writing, Pharmacovigilance / Drug Safety, Complaints management and Regulatory affairs
Life Sciences - Sourcing Advisory and Consultancy Services (LS-SACS)
Edison, New New Jersey, USA