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The pressures are mounting for life sciences companies from both regulators and patients: increasing regulatory mandates, intense pressure on pricing and non-stop technological advancements. To thrive and take the lead, business leaders must address the new imperative head-on.
Compliance and regulatory functions have an opportunity to better align with business strategy and respond to external opportunities/pressure in a drive toward efficiency/effectiveness. Modern compliance organizations are risk intelligent, efficient, and deliver through business partnership and enablement.
With the advent of the COVID-19 pandemic, many companies have had to adapt to a new way of working very quickly. Many countries have installed working-from-home policies which have led to an unprecedented reliance on business-wide connected systems and software. Life Science companies that were previously reliant on paper-based or hybrid quality management systems have had to adapt to an increasingly and irrevocably digital world.
With a workforce that is working remotely rather than in offices, companies have been forced to develop new processes to remain connected and ensure quality and compliance standards are upheld throughout the company and its value chain.
Cloud adoption, agile ecosystems and connected platforms all combine to ensure that information isn’t lost through ineffective communication across departments and teams. This has enabled many Life Science companies to avoid missing issues that could have a dramatic effect, delaying projects, damaging their reputation, or even costing lives.
The rate of mergers and acquisitions that have been taking place within the Life Science industry, along with new quality software and IT systems being introduced all the time, have also led to many challenges. Companies merging and/or adopting different systems throughout the company make it more difficult to adopt comprehensive and uniform quality and compliance strategies.
Another way automation has been applied is to detect high-risk abnormalities in imagery through large-scale interpretation and processing of clinical trial data. Enterprises are reaping the benefits of adopting automation, and it is set to expand through the Life Science industry in 2022 as companies reevaluate how they can incorporate the technology in their business models.
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Cutting Edge Information (CEI) is a market research company that specializes in collecting and analyzing global FMV data. The company’s data covers more than 130 countries and provides hourly FMV rates for over 270 different roles, specialties, and titles.
NuEra Health Alliance is a sought-after consultancy firm with a unique focus on marketing operations for the pharmaceutical, biotech, and medical device industries.
Ginny Murnen, Founder and PresidentWe speak the language, know the OPDP policy guidelines and understand the issues companies confront during a promotion review
NuEra Health Alliance
Management
Ginny Murnen, Founder and President
Karen Ruffner, VP Marketing Operations
Founded in 2001, LectureLinx’s team is a blend of independent thinkers, with diverse backgrounds and education, who are driven to provide their clients a mix of shrewd concepts and inspired ideas. Their deep understanding and knowledge of the global pharmaceutical and life sciences industries uniquely positioned them to prepare their clients for the future, while attending to and accomplishing today’s tasks
SIMCO Electronics is a leading provider of calibration, repair, and software services for manufacturing, life science, and technology organizations. SIMCO helps customers increase quality and reduce costs by offering a complete, integrated set of instrument calibration, repair, and software services. SIMCO services a broad range of scientific equipment from hundreds of manufacturers, with service available at the customer's site or through SIMCO’s worldwide network of accredited laboratories
Aizon is an AI software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production within highly regulated industries. The Aizon AI platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites
Owned and operated in the US, Clinical Research Strategies is a contract research organization and executive management consultancy for start-up and mid-size life sciences companies. Project-specific, fit-for-purpose, ad hoc consulting, and staffing clinical trials is what they do best no matter where you are in your clinical development program
At Qualio, their mission is to help teams building life-saving products get to market in less time, with less cost and less risk. They're bringing fresh thinking to a slow-moving industry that's ripe for change, and it's working - Qualio is the #1 fastest growing platform for emerging life sciences companies and is used in over 75 countries
Red Nucleus integrated decades of healthcare experience across the entire life science product lifecycle. The company offers their clients greater insights and efficiencies, and supports them in their journey to improve health outcomes and the quality of people’s lives
Independently owned and operated, RegScan, Inc. is a provider of world-class compliance information to Fortune 1000 companies. Based in Williamsport, Pennsylvania, RegScan has provided compliance solutions for Health, Safety, & Environmental practitioners for over 30 years. RegScan’s vast regulatory library provides the framework for compliance programs within multiple industries including Manufacturing, Transportation and Distribution, Chemicals, Pharmaceuticals, Oil & Gas, Aerospace, and Governments
At USDM Life Sciences, their purpose is to bring clarity and action at the interplay of technology and regulations to help biotech, pharma, and medical device companies deliver trailblazing outcomes. The company helps their customers utilize cutting-edge technology to increase their speed to market while ensuring continuous compliance and patient safety