Synterex Blog

The Synterex blog shares information about our company, industry, people, and technology.

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The New Frontier of Lean Authoring: Human-Centered Design in Regulatory Writing

In the evolving landscape of regulatory writing, it has become clear that creating clear and compliant documents is no longer ...

The Crucial Role of Accessibility in Medical Writing Authoring Tools: Building Inclusivity from the Design Phase

In the race to bring software solutions to market, many software vendors face the challenge of balancing functionality, speed, and ...

Why Subject Matter Experts Are Essential in Creating AI-Enabled Medical Writing Tools

Imagine playing a game of telephone, but instead of kids passing along a funny phrase, it’s sales representatives trying to ...

The Critical Role of Medical Writers in Pediatric Drug Development

Pediatric drug development is one of the most challenging areas of regulatory writing, where precision, guidance interpretation, and strategic planning ...

Navigating Medication Jenga: The Challenge of Polypharmacy in Geriatric Patients

As we age, the complexity of our health often increases, leading to the management of multiple chronic conditions. This reality ...

Insulin: The Savior of Millions

According to the National Diabetes Statistics Report,1 5.7% of all United States (US) adults with type 1 diabetes rely on ...

Bug Busters: Creative Combat Against Drug-Resistant Infections

In the ever-evolving battle against infectious diseases, the rise of drug-resistant infections poses a significant challenge to global health. These ...

Henrietta Lacks

Henrietta Lacks, an African-American woman, unknowingly contributed to one of the most significant advancements in medical science when cells taken ...

Drug Repurposing: Old Dogs, New Tricks in Medicine

In the ever-evolving landscape of medical research, drug repurposing has emerged as a groundbreaking approach, proving that sometimes old dogs ...

COVID-19: A Pandemic Peril

COVID-19 began as an unexplained respiratory illness in Wuhan, China and quickly spread throughout the world, killing millions of people. ...

Artificial Intelligence (AI): Accelerating Cancer Immunotherapy

Artificial Intelligence (AI) is revolutionizing the field of cancer immunotherapy by accelerating the discovery, development, and delivery of innovative treatments. ...

What Is Digital Employee Experience (DEx) and Why Should It Matter to Medical Writers?

In today’s fast-evolving digital landscape, digital employee experience (DEx) is more than just a buzzword—it’s an essential aspect of organizational ...

National Entrepreneurship Week: Finding Connection and Support in the Entrepreneurial Journey

Entrepreneurship is often celebrated as a path to independence, innovation, and success. Last year, we highlighted the diversity and opportunity ...

Navigating the Frontier: An Introduction to Investigational New Drug (IND)

In the realm of pharmaceutical innovation, the Investigational New Drug (IND) application is a pivotal gateway, marking the initiation of ...

Harvest of Sorrow: The CKDu Crisis

Chronic Kidney Disease of Unknown Etiology (CKDu) has emerged as a pressing public health concern, particularly in regions with high ...

The Curb-Cut Effect and AI-Driven Medical Writing: Accessibility by Design

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The environmental impact of artificial intelligence (AI) is increasingly scrutinized due to the significant energy consumption and carbon emissions associated ...

Embracing Trustworthy AI: Insights from the OECD Principles

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

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

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

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

The National Institute of Standards and Technology (NIST) has developed a comprehensive framework aimed at enhancing the trustworthiness of AI ...

Swetha Pothula: Employee Spotlight

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

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

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

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

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

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

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

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

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

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

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

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

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 Karen Cross Simple reminders to sit up straight, stand tall, stretch and be aware of body alignment Many side ...

Diksha Diundi: Employee Spotlight

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: Trinity Cunningham-Arce    My idea of life at eighteen was very different than it is from life now at ...

Hello, My Pronouns Are…

Pronoun conversations are popping up all over; and, luckily, they’re spreading to the workplace, too. As pronouns are deeply personal, ...
Shoshana holding a pet rabbit.

Shoshana Hereld: Employee Spotlight

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 Katelyn Rivas Medical writers are experts at writing detailed scientific documents geared toward scientists, clinicians, and regulatory agencies. However, ...
Celebrating National Apprenticeship Week: Nurturing tomorrow's clinical trials leaders.

National Entrepreneurship Day: Celebrating Opportunity, Diversity, and Legacy

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

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

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

Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association ...

Juliette Wilson: Employee Spotlight

Today’s Employee Spotlight is on Juliette Wilson, one of our amazing quality control associates. Read our Q&A with her below.  ...
Regulations in Blue Color on a White Background

ICH E6 (R3): Implications of Recent Updates for Medical Writers

Introduction The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released a third revision ...
Person working on a document at a laptop

My Fellowship in Medical Writing: What I Learned

By Katelyn Rivas Last year I had the pleasure of participating in the Synterex Regulatory Writing and Medical Communications Fellowship. ...
Bob headshot

Bob Dann: Employee Spotlight

Today’s Employee Spotlight is on Bob Dann, one of our talented medical writers. Read our Q&A with him below. Where ...
Alisa and her husband on vacation in St Thomas

Alisa Lackey: Employee Spotlight

Today’s Employee Spotlight is on Alisa Lackey, our hardworking Virtual Assistant. Read our Q&A with her below. Where are you ...
image of Natasha and Taylor Headshot

Medical Writing Fellowship Recipients for January 2023

Synterex is excited to welcome Natasha and Taylor, who were accepted into our medical writing fellowship program in January 2023. ...
A Snippet of a Prompt from Chat GPT

Hey ChatGPT? Tell Me a Story

We asked ChatGPT to tell us a story about a medical writer; here’s what it got right and what it ...
Shivangi

Shivangi Trivedi: Employee Spotlight

Today’s Employee Spotlight is on Shivangi Trivedi, one of our talented Medical Writers. Read our Q&A with her below. Where ...
Business education poster graphic

Building a Training Curriculum for Business Education

Business skills matter. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, or scroll ...
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Curating Medical Writing Training Content with Crawl Technology

Crawl technology is a valuable tool for content curation. Download this poster, presented by Synterex at the 2022 American Medical ...
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Making the Most of SharePoint

Five ways to use SharePoint better! Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) ...
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Dealing with Difficult People

Difficult people exist in any profession. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) ...
Checklists for medical writers poster

Checklists for Medical Writers

Checklists are a great tool. Download this poster, presented by Synterex at the 2022 American Medical Writers Association (AMWA) conference, ...
Shalini Dewan

Shalini Dewan: Employee Spotlight

Today’s Employee Spotlight is on Shalini Dewan, our Associate Director, Medical Writing. Read our Q&A with her below! Where are ...
Photo of Christine Iliff drinking a tea

Christine Iliff: Employee Spotlight

Today’s Employee Spotlight is on Christine Iliff, one of our amazing Medical Writing associates. Read our Q&A with her below! ...
Nancy Stover

Nancy Stover: Employee Spotlight

Today’s Employee Spotlight is on Nancy Stover, our amazing Associate Director of Medical Writing! Read our Q&A with her below. ...
Project manager with laptop, phone, and planner

What Does a Regulatory Project Manager Do?

If you work for a team that tackles complex tasks, you are likely familiar with the benefits of having a ...
BDR conference attendees with a wheelchair.

Rock, Paper, Scissors: The Power of Coming Together

As a member of the first cohort of the Merck Drexel Advanced Leadership Program for Diverse Suppliers, I was given ...
Cheryl Kolus with her horse Tater

Cheryl Kolus: Employee Spotlight

Today’s employee spotlight is on Cheryl Kolus, one of our talented Medical Writers. Read our Q&A with her below. Where ...
Blue square with hashtag ADA32

What the ADA Means to a Disability-Owned Business 

As the founder of a disability-owned business enterprise (DOBE), I was proud to attend the Disability:IN conference in Dallas, TX, ...
Chris Schatz

Chris Schatz: Employee Spotlight

Today’s Employee Spotlight is on Chris Schatz, our talented Quality Control Lead. Read our Q&A with him below! Where are ...
Carrie Patrick

Carrie Patrick: Employee Spotlight

Synterex's Employee Spotlight series showcases all the talented and hardworking people on our team! We are kicking off the series ...
Headshots of Katelyn and Alex

Meet Synterex’s 2022 Medical Writing Internship/Fellowship Recipients

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

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

When you look at job descriptions for medical writers, have you noticed that, regardless of the size of the hiring ...
SYNTEREX

How to Make Co-Authoring in Office 365 Work For You

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!

Synterex's new IT services division is open for business! Championed by collaboration architects with over 10 years' experience, IT Services ...