Our Services
Clarity. Precision. Partnership.
At WriteSource Medical, we’re committed to delivering the highest-quality support across medical writing, biostatistics, clinical data management, and training. With a reputation built on agility, ethics, and expertise, our experienced team provides customised solutions to clients in the pharmaceutical, device, and academic sectors. Whether you’re preparing for regulatory submissions, managing clinical data, or upskilling your team, we’re here to support you every step of the way.
Medical writing
Simplifying complexity. Communicating impact.
Our team of professional medical writers excels at simplifying complex medical information, ensuring your documents are clear, concise, and compliant with international standards. We understand that timely and precise communication is critical in the medical field, and we are always prepared to meet your deadlines and exceed expectations.
We offer a full range of medical writing services, including:
Abstracts
Concise and informative abstracts for scientific conferences and journals.
Advisory Board Minutes
Accurate documentation of discussions and decisions made during advisory board meetings.
Clinical Expert Reports
In-depth analysis and interpretation of clinical data to support regulatory submissions and publications.
Clinical Study Reports (CSRs) & Clinical Investigation Reports (CIRs)
Comprehensive reports detailing methodology, results, and conclusions of clinical trials.
Consensus Statements
Developed using the RAND/UCLA methodology to capture expert panel opinions on medical topics.
Ethics Applications
Comprehensive applications to ensure clinical trials meet ethical standards for committee approval.
Grant Applications
Persuasive proposals that highlight the significance and impact of your research projects.
Informed Consent Forms
Clear and comprehensive forms explaining trial procedures, risks, and benefits to participants.
Investigator Brochures
Detailed documents providing essential information about investigational products.
Journal Manuscripts
High-quality manuscripts for peer-reviewed journals, ensuring clarity and accuracy.
Literature Reviews
Thorough reviews that summarise existing research on a specific topic.
Literature-Based Submissions for TGA
Submissions to the Therapeutic Goods Administration (TGA) based on existing literature to support therapy approval.
Marketing Aids
Engaging materials that effectively communicate the benefits of medical products to healthcare professionals and patients.
Meta-Analyses & Systematic Reviews
Combining and analysing data from multiple studies to provide robust evidence.
Patient Information Sheets
Clear, informative content explaining medical conditions, treatments, and procedures to patients.
Posters & Presentations
Professionally designed scientific posters and presentations for conferences and meetings.
Protocols & Clinical Investigation Plans
Detailed outlines of study objectives, design, methodology, and statistical considerations.
Regulatory Submissions
Assistance in preparing sections for eCTD modules supporting drug and device approval (e.g., NDAs, MAAs).
SAE Narratives
Descriptions of serious adverse events in clinical trials.
Website Content
Engaging content for public-facing or specialised audiences.
What about AI in Medical Writing?
While AI tools like Draftsmith and PerfectIt enhance the efficiency of medical writing and editing, human expertise remains irreplaceable. AI can’t match the nuanced understanding of medical terminology, regulatory requirements, or the ethical oversight a professional medical writer offers. Our team brings a deep understanding of these factors to ensure accuracy, originality, and compliance.
Biostatistics
Data-driven decisions made simple.
Our biostatisticians combine the power of statistics with the ability to communicate complex data effectively. We simplify your data, enabling you to make informed, evidence-based decisions. With our agile approach, we tailor our services to meet your specific needs, whether you’re conducting clinical trials, real-world studies, or pharmacokinetic research.
Our biostatistical services include:
Sample Size Calculations
Ensuring your study is adequately powered to detect meaningful differences or associations.
Statistical Analysis Plans (SAPs)
Comprehensive plans outlining statistical methods and analyses.
Data Analysis
Accurate, reliable analysis of clinical study data, including:
- Clinical trials
- Real-world evidence studies
- Pharmacokinetic data
- DELPHI consensus data
Meta-Analyses
Combining data from multiple studies to create a robust, comprehensive assessment.
Interim Analyses
Data-driven decisions regarding the continuation or modification of your study.
Survival Analysis
Analyzing time-to-event data (e.g., disease progression, treatment failure).
Regression Analysis
Exploring relationships between variables to identify predictors of outcomes.
Bayesian Analysis
Incorporating prior knowledge to update the probability of outcomes as new data emerges.
Data Visualization
Clear, informative visualizations to communicate your data effectively.
DELPHI Consensus
Designing and analyzing data for consensus statements using the RAND/UCLA methodology.
Pharmacokinetic / Pharmacodynamic Analysis
Dual expertise in pharmacology and biostatistics to perform these complex analyses.
Clinical data sciences
Efficient data management, tailored for your needs.
At WriteSource Medical, we understand that one size doesn’t fit all when it comes to clinical data management. Our customised solutions ensure your data is accurate, reliable, and compliant with regulatory standards, so you can focus on what truly matters.
Our clinical data management services include:
Case Report Forms (CRF) Design
Tailored forms to capture critical data efficiently.
Database Design
Creating and implementing compliant clinical data management systems.
Data Validation
Ensuring data accuracy, consistency, completeness, and integrity.
Data Standardisation
Supporting implementation of the CDISC model structure.
Data Risk Management
Issue trend analysis and tailored mitigation strategies.
Documentation Review
Reviewing clinical trial documentation and generating data processes.
Data Training
Providing best practices, tips, and tools informed by industry experts.
Training
Empowering your team with practical skills.
WriteSource Medical offers a range of bespoke training courses designed to enhance the knowledge and skills of professionals in the pharmaceutical, device, and academic sectors. Our programs provide practical, immediately applicable skills for teams at all levels.
Medical Writing Training
A Brief Guide to Medical Writing
A half-day workshop tailored to your team’s needs, covering the basics of writing for different audiences
Writing for Patients
A 2-hour course focused on effective communication with patients, including message choice and writing for clarity
Critical Appraisal
A three-hour workshop teaching how to systematically assess the quality of research and apply it in everyday work
Biostatistics Training
Making Sense of Statistics
This course is designed for those with very little statistical knowledge but who need to understand statistics for their job. Delivered as a self-paced, workshop-style format, it covers topics such as types of data, summary statistics, types of studies, hypothesis testing, survival analysis, and meta-analysis.
For reliable, industry-leading assistance in medical writing, biostatistics, and data management, contact WriteSource Medical now to discuss your specific needs. Our agile team is here to support you every step of the way.