Blogs

R&A blog content

  • Biosimilars in the time of COVID-19 and beyond

    Biosimilars in the time of COVID-19 and beyond

    Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...

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  • Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    Critical considerations for re-starting clinical trials in countries recovering after the COVID-19 pandemic

    The COVID-19 pandemic led to a variety of risk-based adjustments to clinical trial conduct. Mitigation measures had to be taken based on a risk assessment by sponsors and investigators in which...

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  • Managing Continuity in Clinical Trials in the COVID-19 environment:  The Decentralized Option and Regulatory Flexibility

    Managing Continuity in Clinical Trials in the COVID-19 environment: The Decentralized Option and Regulatory Flexibility

    Introduction/Situation COVID-19 has created a number of challenges in managing clinical trials for acute, chronic, life-threatening, and rare diseases. Due to the pandemic, as many as 90% of...

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  • Vendor Audits and cGMPs

    Vendor Audits and cGMPs

    Industries are taking ongoing actions in their response efforts to COVID-19 and this includes being prepared for Regulatory Authority CGMP requirements which include Vendor Audits. FDA through...

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  • Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19

    Perspectives on Three Recent Policies for Alcohol-Based Hand Sanitizer for Manufacturers during COVID-19

    The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...

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  • Understanding the COVID-19 regulatory procedures the FDA is using

    Understanding the COVID-19 regulatory procedures the FDA is using

    A diagram that shows various procedural steps when interacting with the FDA through CTAP.

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  • Expediting Biotech Product Development During the COVID-19 Pandemic using Modular Validation Approaches

    Expediting Biotech Product Development During the COVID-19 Pandemic using Modular Validation Approaches

    For over three months the world has been battling COVID-19. COVID-19 is unforgiving and has the ability to overwhelm even the strongest health system or regulatory regime. Even though the...

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  • Preparing for the Post COVID-19 Regulatory Environment

    Preparing for the Post COVID-19 Regulatory Environment

    Recently, the FDA Commissioner (Dr. Stephen Hahn) and the Director for the Center for Drug Evaluation (CDER) (Dr. Janet Woodcock) remarked that the very recently created Coronavirus Treatment...

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  • COVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials

    COVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials

    Following successful completion of Phase 1 healthy subjects’ studies and animal challenge tests as discussed in Part 2, a number of strategies are possible to demonstrate vaccine efficacy. Such...

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  • COVID-19 Vaccine Development - Part 2: Non-clinical and Early phase clinical development

    COVID-19 Vaccine Development - Part 2: Non-clinical and Early phase clinical development

    Clearly, the potential for vaccines to enhance rather than protect against infection through the two mechanisms of ADE and ERD discussed in Part 1, highlights the need for studies in animal models...

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  • COVID-19 Vaccine Development - Part 1: Progress and Challenges

    COVID-19 Vaccine Development - Part 1: Progress and Challenges

    The enormous societal impact and global mortality, now over 150,000, that has resulted from the rapid spread of SARS-CoV-2, an enveloped RNA virus, underscores the criticality for accelerated...

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  • Part Two: The Unique Impact of COVID-19 and Implications for the MSK Industry

    Part Two: The Unique Impact of COVID-19 and Implications for the MSK Industry

    About Health Advances and Our Musculoskeletal Practice Health Advances is a healthcare-focused strategy...

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  • The Great Lockdown of 2020: Will the Life Sciences Emerge Unscathed?

    The Great Lockdown of 2020: Will the Life Sciences Emerge Unscathed?

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  • Part 4: ‘Learnings from China: Managing in the time of pandemic’

    Part 4: ‘Learnings from China: Managing in the time of pandemic’

    In earlier blogs, we examined how Parexel worked with sponsors, sites, and regulators to ensure patient safety and business continuity in the thick of the pandemic, and what biopharma and CROs...

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  • Rapid Responders: How Innovative Technologies are Accelerating Development of New Vaccines

    Rapid Responders: How Innovative Technologies are Accelerating Development of New Vaccines

    About the Authors Joseph McInnes, PhD is a Senior Analyst in the Health...

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  • COVID-19 and the Medtech Industry: ASCs – Accelerating an Already Changing Market

    COVID-19 and the Medtech Industry: ASCs – Accelerating an Already Changing Market

    About Health Advances Global MedTech Practice Health Advances MedTech Practice supports medical device...

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  • COVID-19 and the Medtech Industry: Procedure Deferral Index

    COVID-19 and the Medtech Industry: Procedure Deferral Index

    “We believe the market for orthopedic procedure volumes temporarily decelerated on a global...

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  • Viv podcast: Supply Chain Management During Times of Uncertainty

    Viv podcast: Supply Chain Management During Times of Uncertainty

    A discussion with Siegfried Schmitt

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  • US SARS-CoV-2 Testing Response: What can be learned from South Korea and Germany?

    US SARS-CoV-2 Testing Response: What can be learned from South Korea and Germany?

    About the Authors Aaron Dy, PhD is a Senior Analyst in the Health...

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  • Staying connected with your important clinical trial stakeholders – getting the most from your virtual meetings

    Staying connected with your important clinical trial stakeholders – getting the most from your virtual meetings

    The emergence of the global COVID-19 pandemic has driven rapid change in the way that we engage, with unprecedented utilization of virtual platforms across industries. In the clinical trial...

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