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The lifesciences history industry has some unique challenges when it comes to compliance. But if you think third party compliance risks are bad, don’t take your eye off fourth and fifth parties, says Allan Matheson. In 2020, lifescience firms accounted for a third of the SEC’s enforcement actions.
Research from Everest Group shows how lifesciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.
Cloudbyz’s inclusion in this respected benchmark report underscores its dedication to advancing clinical trial management through robust, innovative technology designed to optimize data collection, ensure regulatory compliance, and streamline trial processes. “We
Compliance with complex laws and regulations, like Direct-to-Consumer Advertising (DTCA) Rules or the Health Insurance Portability and Accountability Act (HIPAA), can be quite daunting. And it is not hard to see why.
Lifescience consulting can be a rewarding career and the job outlook is promising for the future. . Perhaps you have heard of lifescience consulting jobs but do not exactly know what type of work is involved, or the education and experience needed to become a lifescience consultant. Job Description.
Remaining compliant is imperative to the lifesciences industry, so adhering to regulatory requirements is mandatory. Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in.
A successful lifescience webinar engages the audience in a unique manner, drives the right kind of traffic and provides genuine value for attendees. Here are 5 trending lifescience webinar topics that have been resonating well with our audiences. Then view our past lifescience webinars here.
In the dynamic world of lifesciences, where innovation is paramount, the integration of cutting-edge technologies is crucial for accelerating clinical operations and driving breakthroughs in healthcare. Salesforce’s recent announcement of its LifeSciences Cloud marks a significant stride towards this goal.
However, issues like compliance, governance and security often are. That’s why CIOs and CTOs working within the lifesciences industry need to include Salesforce org management as a key component of their standard operating procedures. This will help ensure consistency and compliance across the entire enterprise. .
The lifesciences landscape is moving at a rapid pace, which in turn is increasing the demands on marketers to create innovative, digital content faster while maintaining industry compliance. Veeva Systems recently conducted an annual industry study, focused on content and digital asset management within lifesciences.
It highlights the importance of ethical standards, due diligence and regulatory compliance, and underscores the potential risks associated with over-hyped or fraudulent startups. Lifescience startups face unique challenges given the highly regulated and complex nature of the industry.
From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables lifesciences teams to collaborate efficiently and effectively in 2023. The post 6 research and development lifesciences predictions for 2023 appeared first on.
Claudia Grimaldi is currently Vice President, Principal Finance Officer, and Chief Compliance Officer at IGC. She has been with the company for almost 12 years with increasing responsibilities including managing SEC and NYSE filings, regulatory compliance and disclosures.
Cloudbyzs dual recognition underscores its commitment to innovation , regulatory compliance, and enhanced trial efficiency. As lifesciences organizations increasingly seek digital transformation , Cloudbyz continues to deliver solutions that simplify workflows and accelerate drug development timelines.
The draft also formalizes withdrawal procedures for non-compliance, including delayed studies or failure to confirm benefits. Notably, the FDA can now mandate that confirmatory trials begin before approval, ensuring proactive validation of clinical benefits.
21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Food and Drug Administration (FDA).
By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in LifeSciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. GLP-1s – Exploring the Anticipated Compliance and Litigation Risks.
It works because it’s been designed from the ground up for lifesciences. TEDAVI uses robust methodologies, cutting-edge platforms and AI-driven capabilities to help clients overcome regulatory challenges, reduce costs, streamline creation and review, and enable personalization – all while maintaining compliance.
Verista is a LifeSciences business, technology and compliance firm specializing in systems, quality, and validation solutions throughout the product lifecycle. Its acquisitions and integrations have been carefully calculated and culminated into a lifesciences powerhouse that helps clients solve critical and complex challenges.
This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to lifesciences organizations worldwide. This prestigious recognition positions Cloudbyz among the top performers in delivering intuitive and scalable EDC solutions to lifesciences organizations worldwide.
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UCTMS also helps organizations ensure compliance with regulatory guidelines and provides robust data security features. By automating these processes, Cloudbyz CTMS helps lifesciences companies conduct clinical trials more efficiently. These features help lifesciences companies remain compliant and avoid costly fines.
Lifesciences organizations can easily send customizable, templated text messages and digital assets without compromising compliance. We have experienced significant demand for our text messaging platform within the lifesciences industry,” stated Arist Co-founder and CEO Michael Ioffe. “To Onboarding and Training.
In the rapidly evolving landscape of lifesciences, the need for robust, efficient, and compliant pharmacovigilance (PV) solutions has never been greater. In this blog, we’ll explore how these solutions are transforming pharmacovigilance and why they are becoming the go-to choice for forward-thinking lifesciences companies.
Porzio LifeSciences Launches Porzio GST, U.S. and Global Transparency Solution for the LifeSciences Industry Porzio LifeSciences Launches Porzio GST, U.S. and Global Transparency Solution for the LifeSciences Industry MORRISTOWN, N.J.–(BUSINESS
In 2023, there were significant advancements and notable trends in the lifesciences. Xtalks compiled a list of its top lifescience news and trends of 2023, which provided readers with the latest developments, information and expert insights across lifescience industries, including pharma, biotech and medical device.
OSP spoke to Vladamir Penkrat, head of safety and regulatory and Shuba Rao a senior director at Indegene, a lifesciences digital company about a paper they recently published called 'Challenges and Future of PV Compliance' about the direction compliance is headed and how they would convert risk-based approaches into a confidence-based assurances. (..)
In the dynamic landscape of clinical trials, ensuring compliance and maintaining high-quality standards are paramount. The field of quality and compliance in clinical trials is undergoing significant transformations driven by technological advancements, regulatory changes and evolving industry practices.
The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), HPM Director Anne Walsh will moderate a panel discussion on “Due Diligence and Mitigating Securities Violation Risks for Emerging LifeScience and Novel Food Companies.”
Darshan Kulkarni and Marc Banjak, General Counsel at Dova Pharmaceuticals, discuss sales compliance in the lifesciences. Sales and marketing representatives in the lifescience industry must comply with state and federal regulations. What are these regulations and how should you navigate them?
In today’s digital age, lifesciences organizations are collecting, storing, and processing vast amounts of sensitive data, including personally identifiable information (PII) and protected health information (PHI). As such, it’s becoming increasingly challenging for organizations to manage and secure this data.
Employee retention and motivation is a challenge that all lifescience companies face. A corporate compliance training program is a part of many onboarding programs to ensure employees are up to date with the latest rules and regulations they must adhere to while working for the company. Training and Development Opportunities.
Find out what 500 global clinical operations professionals had to say as they shared their experiences and opinions on the progress of modernizing clinical operations in lifesciences.
Increase study quality and compliance.
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This solution is designed to meet the unique needs of clinical research organizations (CROs) and pharmaceutical companies, offering a range of features to help them streamline their operations, manage clinical trials, and ensure compliance with regulatory requirements.
FAIRFAX, VA, December 15, 2020 /24-7PressRelease/ — Quality and Regulatory Compliance requirements can present impediments to progress. However, these requirements also reveal opportunities to re-envision a team’s effectiveness, renovate processes, and enable newer technologies to revamp business-as-usual.
SPAR Solutions provides agile, innovative solutions to help clients leverage the Salesforce platform as their primary business engine The joint partnership, powered by Cloudbyz ’s Clinical Research Management Platform and SPAR Solutions, holds immense promise for the healthcare and lifesciences sectors.
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However, the implementation of these while maintaining compliance with internal company guidelines can prove challenging and can be difficult to navigate without support and guidance. Gareth Powell is a business development officer for the NIHR Clinical Research Network (CRN). Gareth has been with the Clinical Research Network since 2009.
Lifescience companies invest a significant number of resources to engage physicians and patient advocates. In a new whitepaper, Best Practice Guide: Insights Management and Virtual Patient Engagement, Within3 provides a detailed roadmap to help lifescience companies navigate engagement in the virtual world.
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