Synterex Blog
The Synterex blog shares information about our company, industry, people, and technology.
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The Curb-Cut Effect and AI-Driven Medical Writing: Accessibility by Design
By Synterex | | Technology
The curb-cut effect refers to the broad and often unexpected benefits of designing for accessibility. Originally intended to assist people ...
The Challenges and Benefits of Implementing e-Consent in Clinical Trials
By Synterex | | Thought leadership
As clinical trials evolve in the digital age, e-consent has emerged as a promising tool to enhance patient engagement, streamline ...
The Flip Side of Lean Authoring: Navigating the Complexities of Cross-Functional Negotiation
By Synterex | | Thought leadership
Lean authoring, a method popularized by medical writing expert Gregory Cuppan, emphasizes streamlined, focused writing that delivers key messages without ...
Project Deadlines, Dynamic Demands, Work-Stress! YOGA to the Rescue
By Synterex | | Other
Deadlines to meet, projects to juggle, and dynamic demands? Work can be stressful at times. It’s no wonder people feel ...
Remote Rx: Writing from Home – Perks & Challenges
By Synterex | | Other
In today's ever-evolving work environment, shaped by the aftermath of the COVID-19 pandemic, the once-standard 9-to-5 office routine is rapidly ...
Key Considerations for Submitting Your NDA or BLA to FDA on a Rolling Basis
By Synterex | | Medical Writing & Pharma
Establishing early alignment with the FDA on the rolling submission approach is pivotal to your success. Before you initiate any ...
Chronicles of Drug Development and FDA: Review, Approve, Monitor
By Synterex | | Thought leadership
For a drug to get on the market in the United States, it must go through a rigorous review by ...
Best Practices for Managing Information Requests from Health Authorities
By Synterex | | Thought leadership
Managing information requests from health authorities such as the FDA is a critical aspect of regulatory compliance for pharmaceutical companies. ...
Biosimilar Laughs: A Chuckle in Every Dose
By Synterex | | Medical Writing & Pharma
What is a Biosimilar? In the scientific realm, biosimilars, akin to their reference products, are biologic medications. Approval for biosimilars ...
10 Most Common Risks to Your BLA or NDA Timeline (and How to Mitigate Them)
By Synterex | | Medical Writing & Pharma
When pursuing a Biologics License Application (BLA) or New Drug Application (NDA), meeting timelines is crucial. However, the path to ...
A Day in the Life of a Medical Writer
By Synterex | | Company News
Step into the dynamic world of medical writing at Synterex and discover a day in the life of our talented ...
Writing Regulatory Submissions with the Label in Mind: Key Strategies for Success
By Synterex | | Medical Writing & Pharma
When preparing regulatory submissions, especially in fields like oncology, it's crucial to focus on the end goal—the drug's label or ...
Taylor Friend: Employee Spotlight
By Synterex | | Other
Today’s Employee Spotlight is on Taylor Friend, one of our amazing medical writers. Read our Q&A with her below. How ...
Keeping Cultural Differences in Mind as We Create Documents
By Synterex | | Thought leadership
As Americans, we tend to be very insular in our thinking. Since we don’t generally need to know another language, ...
Aspartame: Oh, Not So Sweet
By Synterex | | Other
People started becoming afraid of aspartame after its labeling as “possibly carcinogenic to humans” by the World Health Organization (WHO) ...
How AgileWriter Addresses Common AI Concerns
By Synterex | | Technology
In the rapidly evolving landscape of artificial intelligence, ensuring that generative AI systems adhere to robust standards is crucial. The ...
Harnessing AI for Clinical Documentation in the Biopharma Value Chain: The Benefits of a Technology-Agnostic Approach
By Synterex | | Technology
In the fast-evolving biopharmaceutical industry, the integration of artificial intelligence (AI) into clinical documentation processes presents an unprecedented opportunity to ...
Unlocking the Power of Explainable AI in Content Creation
By Synterex | | Other
As artificial intelligence (AI) permeates various aspects of life and business, the importance of explainable AI (XAI) grows, particularly in ...
Harnessing AI and LLMs to Enhance Lean Authoring Principles
By Synterex | | Technology
In recent years, lean authoring principles have emerged as a cornerstone for efficient and effective communication. These principles, which emphasize ...
The World Health Organization’s Cautious Approach to AI in Healthcare: A Continuation and Expansion of Ethical Guidelines
By Synterex | | Technology
The World Health Organization (WHO) has long been a guiding force in global health issues, setting standards and offering recommendations ...
Understanding Confabulations in AI: Causes, Prevention, and Detection
By Synterex | | Technology
Artificial intelligence (AI) systems are increasingly integrated into various sectors, including healthcare, finance, and customer service, making their reliability and ...
Exploring the Universal Guidelines for AI and Their Impact on Global Policy
By Synterex | | Technology
In an era dominated by rapid advancements in artificial intelligence (AI), the need for robust governance frameworks has never been ...
Developing and Maintaining Metrics for Clinical Documentation Production and Understanding ROI in Artificial Intelligence (AI) Tools
By Synterex | | Technology
Clinical documentation is a critical component in the healthcare and pharmaceutical industries, serving as the backbone for clinical studies, regulatory ...
Understanding “Human in the Loop” in AI Software and Its Crucial Role in Clinical Documentation
By Synterex | | Other
In today’s rapid digital transformation of the clinical trials space, artificial intelligence (AI) is becoming an indispensable part of meeting ...
Ink with Integrity: Necessary Ethics in Medical Writing
By Synterex | | Thought leadership
In the realm of medical writing, titles like "regulatory" or "pharma" may take center stage, overshadowing the less emphasized term ...
Pioneering Sustainable Practices in AI Technology
By Synterex | | Technology
The environmental impact of artificial intelligence (A) is increasingly scrutinized due to the significant energy consumption and carbon emissions associated ...
Embracing Trustworthy AI: Insights from the OECD Principles
By Synterex | | Technology
Artificial intelligence (AI) continues to reshape industries, societies, and economies globally. As AI technologies evolve and integrate deeper into various ...
Embracing the 11 × 11 Tipping Point: Transforming Medical Communications with AI
By Synterex | | Technology
In the rapidly evolving landscape of artificial intelligence (AI), the "11 × 11 tipping point" has emerged as a critical ...
Harnessing Artificial Intelligence for a Sustainable Future: Insights from the United Nations Resolution on Artificial Intelligence
By Synterex | | Technology
The United Nations General Assembly in March 2024 adopted a significant resolution aimed at leveraging artificial intelligence (AI) for sustainable ...
Spotting the Hyperbole: Why AI Can’t Replace Medical Writers
By Synterex | | Technology
In recent years, the integration of Artificial Intelligence (AI) into various sectors has sparked widespread discourse, particularly concerning its application ...
Brief Overview of the NIST AI Risk Management Framework
By Synterex | | Technology
The National Institute of Standards and Technology (NIST) has developed a comprehensive framework aimed at enhancing the trustworthiness of AI ...
Swetha Pothula: Employee Spotlight
By Synterex | | Other
Today’s Employee Spotlight is on Swetha Pothula, one of our amazing senior medical writers. Read our Q&A with her below. ...
Understanding the Eisenhower Matrix: Your Guide to Identifying AI Pilot Use Cases
By Synterex | | Technology
In today's fast-paced world, effective time management and prioritization are crucial. Enter the Eisenhower Matrix, a powerful tool that can ...
Best Practices for Launching a Successful AI Pilot for Clinical Documentation Software
By Synterex | | Technology
Implementing an AI pilot project for clinical documentation software requires meticulous planning and strategic execution. Here are the essential best ...
Understanding NIST’s Generative AI Profile Guidance: Key Tasks and Actions
By Synterex | | Technology
In the rapidly evolving field of artificial intelligence, NIST's new Generative Artificial Intelligence (genAI) Profile guidance offers crucial strategies for ...
A Deep Drive into NIST’s Generative AI Intelligence Profile: Ensuring Safety and Integrity
By Synterex | | Technology
Introduction The National Institute of Standards and Technology (NIST) has crafted a robust framework aimed at guiding the responsible development ...
A Guide to Implementing a Governance Model for AI Software for Clinical Documentation
By Synterex | | Technology
Introduction In the rapidly evolving landscape of healthcare, artificial intelligence (AI) is transforming the way clinical documentation is managed. As ...
Get the Most from Your Document’s Quality Control Review
By Synterex | | Technology
Toward the end of clinical document development, a quality control (QC) review is needed to verify data, check facts, ensure ...
Why Incorporating ATAG Guidelines is Crucial for AI-Enabled Authoring Systems: A Perspective from a Disabled-Owned Company
By Jeanette Towles | | Other
Introduction: In today’s digital age, accessibility in technology is not just a feature—it's a necessity. As a disabled-owned company, we ...
Lizz Patterson: Employee Spotlight
By Synterex | | Other
Today’s Employee Spotlight is on Lizz Patterson, our hardworking business operations associate. Read our Q&A with her below. Where are ...
The 2 Types of Remote Work Environment
By Synterex | | Other, Thought leadership
We’ve all seen a lot of articles in the last few years about the pros and cons of the remote ...
Julia Kobel: Employee Spotlight
By Synterex | | Other
Today’s Employee Spotlight is on Julia Kobel, one of our talented medical writers. Read our Q&A with her below. Where ...
Ticklish Rats and the 3Rs of Animal Testing
By Synterex | | Other
Interested in becoming a Certified Rat Tickler? It’s not a joke; the certification is offered through Purdue University (Indiana, USA), ...
Regulatory project management: keeping things on track
By Synterex | | Medical Writing & Pharma
Writing is often thought of as a solitary task. An author sits in a quiet, isolated environment, plugging away with ...
How’s your posture? (Head, shoulders, knees and toes)
By Synterex | | Other, Thought leadership
By Karen Cross Simple reminders to sit up straight, stand tall, stretch and be aware of body alignment Many side ...
Diksha Diundi: Employee Spotlight
By Synterex | | Other
Today’s Employee Spotlight is on Diksha Diundi, one of our fantastic medical writing fellows. Read our Q&A with her below. ...
From Teen to Troop to Intern
By Synterex | | Other
By: Trinity Cunningham-Arce My idea of life at eighteen was very different than it is from life now at ...
Hello, My Pronouns Are…
By Synterex | | Thought leadership
Pronoun conversations are popping up all over; and, luckily, they’re spreading to the workplace, too. As pronouns are deeply personal, ...
Shoshana Hereld: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Shoshana Hereld, our amazing accounting assistant. Read our Q&A with her below. Where are you ...
How to Write About Science for a Lay Audience
By pwsadmin | | Thought leadership
By Katelyn Rivas Medical writers are experts at writing detailed scientific documents geared toward scientists, clinicians, and regulatory agencies. However, ...
National Entrepreneurship Day: Celebrating Opportunity, Diversity, and Legacy
By Jeanette Towles | | Thought leadership
National Entrepreneurship Day is a celebration of innovation, determination, and the pursuit of the American dream. It's a day to ...
Celebrating National Apprenticeship Week: Nurturing Tomorrow’s Clinical Trials Leaders
By Jeanette Towles | | Thought leadership
Introduction: In the ever-evolving landscape of clinical trials, where the stakes are high and the demands are relentless, the value ...
Kelsea Medeiros: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Kelsea Medeiros, one of our talented medical writing operations associates. Read our Q&A with her ...
Your Document’s Path to a Successful Quality Control Review
By Synterex | | Medical Writing & Pharma
Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association ...
Juliette Wilson: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Juliette Wilson, one of our amazing quality control associates. Read our Q&A with her below. ...
ICH E6 (R3): Implications of Recent Updates for Medical Writers
By Synterex | | Biotechnology, Medical Writing & Pharma, Technology
Introduction The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision ...
My Fellowship in Medical Writing: What I Learned
By Synterex | | Medical Writing & Pharma
By Katelyn Rivas Last year I had the pleasure of participating in the Synterex Regulatory Writing and Medical Communications Fellowship. ...
Bob Dann: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Bob Dann, one of our talented medical writers. Read our Q&A with him below. Where ...
Alisa Lackey: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Alisa Lackey, our hardworking Virtual Assistant. Read our Q&A with her below. Where are you ...
Medical Writing Fellowship Recipients for January 2023
By Synterex | | Company News
Synterex is excited to welcome Natasha and Taylor, who were accepted into our medical writing fellowship program in January 2023. ...
Hey ChatGPT? Tell Me a Story
By Jeanette Towles | | Medical Writing & Pharma, Technology
We asked ChatGPT to tell us a story about a medical writer; here’s what it got right and what it ...
Shivangi Trivedi: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Shivangi Trivedi, one of our talented Medical Writers. Read our Q&A with her below. Where ...
Building a Training Curriculum for Business Education
By Synterex | | Medical Writing & Pharma
Business skills matter. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll ...
Curating Medical Writing Training Content with Crawl Technology
By Synterex | | Technology
Crawl technology is a valuable tool for content curation. Download this poster, presented by Synterex at the 2022 American Medical ...
Making the Most of SharePoint
By Synterex | | Technology
Five ways to use SharePoint better! Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) ...
Dealing with Difficult People
By Synterex | | Medical Writing & Pharma
Difficult people exist in any profession. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) ...
Checklists for Medical Writers
By Synterex | | Medical Writing & Pharma
Checklists are a great tool. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, ...
Shalini Dewan: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Shalini Dewan, our Associate Director, Medical Writing. Read our Q&A with her below! Where are ...
Christine Iliff: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Christine Iliff, one of our amazing Medical Writing associates. Read our Q&A with her below! ...
Nancy Stover: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Nancy Stover, our amazing Associate Director of Medical Writing! Read our Q&A with her below. ...
What Does a Regulatory Project Manager Do?
By Synterex | | Medical Writing & Pharma
If you work for a team that tackles complex tasks, you are likely familiar with the benefits of having a ...
Rock, Paper, Scissors: The Power of Coming Together
By Jeanette Towles | | Company News
As a member of the first cohort of the Merck Drexel Advanced Leadership Program for Diverse Suppliers, I was given ...
Cheryl Kolus: Employee Spotlight
By Synterex | | Company News
Today’s employee spotlight is on Cheryl Kolus, one of our talented Medical Writers. Read our Q&A with her below. Where ...
What the ADA Means to a Disability-Owned Business
By Jeanette Towles | | Company News
As the founder of a disability-owned business enterprise (DOBE), I was proud to attend the Disability:IN conference in Dallas, TX, ...
Chris Schatz: Employee Spotlight
By Synterex | | Company News
Today’s Employee Spotlight is on Chris Schatz, our talented Quality Control Lead. Read our Q&A with him below! Where are ...
Carrie Patrick: Employee Spotlight
By Synterex | | Company News
Synterex's Employee Spotlight series showcases all the talented and hardworking people on our team! We are kicking off the series ...
Meet Synterex’s 2022 Medical Writing Internship/Fellowship Recipients
By Synterex | | Company News, Medical Writing & Pharma
Each year, Synterex is proud to welcome students and postgrads to a medical writing internship or fellowship. Our current intern, ...
Key Takeaways for the Medical Writer from FDA’s Public Meeting: Supporting the Future of Rare Disease Product Development
By Jeanette Towles | | Medical Writing & Pharma
FDA’s public meeting on February 24th left no uncertainty as to the future direction of drug development in rare disease: ...
Defining ‘Medical Writer’ in a Job Description When the Role Defies Definition
By Jeanette Towles | | Medical Writing & Pharma
When you look at job descriptions for medical writers, have you noticed that, regardless of the size of the hiring ...
How to Make Co-Authoring in Office 365 Work For You
By Jon Towles | | Technology
Co-authoring has grown to become a huge part of our lives regardless of the industry. People can collaborate on documents ...
Synterex’s New IT Services Division is LIVE!
By Jeanette Towles | | Company News
Synterex's new IT services division is open for business! Championed by collaboration architects with over 10 years' experience, IT Services ...