Business Consulting and Digital Transformation 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.
Digital Clinical Transformation
Life sciences companies are pursuing digital initiatives across many processes and the following seven areas are expected to deliver maximum benefits due to digital transformation initiatives:
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 has been assisting 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 Operations and Performance Excellence - Clinical, PV Safety, Regulatory Affairs and other areas
Business and Digital Transformation
Digital Clinical Operating Model, RACI, Governance
People & Organizational Change / Communications
R&D Technology Strategy and Transformation
Business Process Mapping / Reengineering
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:
While newer digital, AI, mobile, and cloud technologies are becoming available, companies are struggling to design, implement, and realize the comprehensive digital transformation benefits. Even though 90% ofcompanies have started some type of digital transformation initiatives, only a third of the expected ROI/revenue benefits, on average,have been realized. In the successful cases, comprehensive planning and a holistic, integrated approach across strategy, process, technology, data, people, and other areas created the transformational value.
LS-SACS has developed a holistic approach for the successful design and implementation of a Digital Clinical Transformation program. Our Digital Clinical Transformation Maturity Assessment (DCTMa) and proven business / digital transformation implementation framework and tools can allow clients to identify gaps and develop a tangible plan to close the gaps and establish a robust Digital Clinical Transformation roadmap.
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.
Life Sciences - Strategic Advisory and Consultancy Services (LS-SACS)
Edison, New New Jersey, USA