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Insights


How Assessment Aids Can Help You Get Your Oncology Product Approved Faster
A guide for applicants who want to participate in the voluntary program developed by the FDA's Oncology Center of Excellence Are you...


How Biotech Teams Should Approach Protocol Writing to Avoid Amendments
Get it right the first time—with less rework, fewer delays, and more clarity Introduction Biotech teams are often working at full...


Innovative use of master protocols for pivotal studies in rare diseases
EMWA Journal - Volume 34, Issue 1, Rare Diseases Author - Philip Burridge , Julie Eastgate Abstract Recent years have seen the...


How to Write a Clinical Study Report
Morula Health’s guide to writing a clear and compliant CSR Clinical Study Reports (CSR) are regulatory documents which provide a...


How to Deliver Module 2 of an NDA in 12 Weeks
Strategic Planning for Accelerated NDA Module 2 Delivery Imagine you’re tasked with writing a Phase 3 Clinical Study Report (CSR), along...


How Can Talent as a Service (TaaS) Revolutionize Your Medical Writing?
Explore how Morula Health's groundbreaking TaaS model addresses the changing demands of biotech companies In the fast-paced world of...


Breaking Down Silos: Key Takeaways from PHUSE and Their Implications for Medical Writing
Learning from other industries: Why reinvent the wheel? Many challenges faced in medical writing, data science, and clinical research are...


Implementing Risk Management in Medical Writing: Ensuring Quality at Every Stage
Proactively Identifying and Mitigating Risks to Deliver High-Quality Medical Writing Medical writing is a cornerstone of clinical...


The evolution of biotechnology
From ancient civilisations to modern day EMWA Journal - Volume 32, Issue 4 Author - Lucy Hargreaves This article explores the intertwined...


5 KPIs to measure success in medical writing projects
Understanding the metrics that matter for medical writing success Introduction Medical writing might not be the first thing that comes to...


Insights from the BioInfect Conference: Tackling Antimicrobial Resistance with Innovation and Collaboration
Key takeaways and how Morula Health is making a difference Antimicrobial Resistance (AMR) remains one of the biggest global health...


How We Assign the Right Medical Writer to Your Projects
Aligning Expertise with Your Unique Needs In the world of biotech, documentation isn't just paperwork—it's the backbone of regulatory...


Journey to an IND Submission
The critical role of medical writing for regulatory interactions, nonclinical IND sections and preparing for clinical trials The path...


People and Processes That Deliver Results
The Key to Exceptional Medical Writing Services Introduction People and processes are the bedrock of success for any service provider....


Morula Health: Our Year in Review
2024 Highlights Report As we conclude another remarkable year, it's essential to reflect upon the challenges we faced, the successes we...


How to Deliver a Successful Kick-Off Meeting
Ensuring a Seamless and Effective Start to Your Project What is a kick-off meeting? A kick-off meeting is the first official gathering...


Finding Your Fit: The Best Approach to Outsourcing Medical Writing
So, you’ve decided to outsource your medical writing needs - What approach will you take? Some biotech companies choose to include...


The Value of Project Management Support for Medical Writers
Medical writers play a pivotal role in regulatory submission writing - but they're just one process component. Regulatory submission...


The Importance of Soft Skills for Medical Writers
Navigating the Intersection of Skill and Sensibility In the rapidly evolving landscape of medical writing, the development of soft skills...


Breaking Barriers: Facilitating FDA Approval
A Case Study of Streamlining IND Submission for a Leading South Korean Pharma Company
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