The Need for Bespoke Medical Writing and Secondary Research in Life Sciences and Healthcare
Published on: 20 Sept 2025
Last updated: 20 Sept 2025
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How Ascentrik’s Customised Services are a Solution to Increased Documentation for Regulatory Agencies
The life sciences and healthcare industries are undergoing rapid transformation, driven by evolving market dynamics, increased regulatory scrutiny, and the pressure to accelerate innovation. As pharmaceuticals, biotechnology firms, and medical device companies strive to bring products to market faster, one key function has gained heightened importance — medical writing.
Once considered a support activity, medical writing has become essential to the drug development lifecycle. It bridges the gap between complex scientific research and the need for clear, compliant communication with regulatory authorities, healthcare professionals, and patients.
In this context, bespoke or customised medical writing services have emerged as an indispensable asset for organisations seeking precision, reliability, and compliance in their scientific documentation.
With bespoke research companies, the approach to medical writing is grounded in custom research, accuracy, and domain expertise. Through a team of full-time researchers and writers, data partners provide tailored medical writing solutions that address the unique needs of every client in the life sciences and healthcare sectors.
The Growing Importance of Medical Writing in Healthcare
Pharmaceutical and healthcare companies increasingly rely on clear, standards-compliant documentation to comply with stringent global regulations. Changing market dynamics such as expiring patents, rising R&D costs, and complex global submission requirements have intensified the demand for medical writing support.
Medical writers ensure that clinical data, scientific information, and product details are presented clearly and logically for diverse audiences — from regulatory reviewers and clinicians to patients.
Their role extends to ensuring compliance with evolving international standards such as those defined by the International Council for Harmonisation (ICH), the Food and Drug Administration (FDA), and the European Medicines Agency (EMA).
Defining Medical Writing
Medical writing involves creating structured scientific documents that accurately represent medical or clinical research data. These documents are used across a range of purposes in healthcare, pharmaceutical, and medical device industries.
Broadly, medical writing falls into two main categories:
Regulatory Medical Writing: This includes documents necessary for regulatory submissions such as clinical study reports, protocols, patient informed consent forms, investigator brochures, and Common Technical Documents (CTDs). These documents must adhere to strict guidelines and formats because they directly impact product approvals and compliance with health authorities.
Educational Medical Writing: This category focuses on developing content for healthcare professionals and general audiences. Examples include medical journal articles, conference presentations, CME/CE materials, health website content, and consumer education programs. Educational medical writing plays a critical role in scientific communication and product promotion.
Other specialised areas include medical journalism, communications, and marketing content development for pharmaceutical brands.
The Impact of Artificial Intelligence on Medical Writing
Artificial intelligence (AI) has started to influence the medical writing process. AI-powered tools use natural language processing (NLP) and machine learning to generate initial drafts, format documents, and summarise complex data. These tools improve efficiency in document preparation and data handling.
However, while AI can automate basic drafting or formatting, it lacks the critical reasoning and domain-specific understanding that skilled medical writers bring. The nuances of regulatory language, the interpretation of clinical results, and ethical considerations in communication all require human expertise.
At Ascentrik Research, we embrace technology where it enhances productivity but always maintains a human-led data sourcing and validation process. Every document undergoes detailed review and verification to ensure accuracy, clarity, and regulatory compliance.
The Shift Toward Bespoke Medical Writing Services
Traditional medical writing models — whether in-house or outsourced — often rely on standard templates or generalised approaches. However, as clinical research becomes more complex and product portfolios diversify, companies are increasingly looking for writing partners who can adapt to their exact requirements.
Bespoke medical writing refers to customised, client-specific document creation that accounts for variations in study design, therapeutic area, regional guidelines, and audience expectations.
Instead of a one-size-fits-all model, bespoke writing ensures that each document is tailored, accurate, and relevant.
This approach delivers several benefits:
Precision and Relevance: Custom-tailored documents reflect the unique research data and study parameters of each organisation.
Regulatory Compliance: Bespoke writing ensures alignment with specific regulatory frameworks, reducing submission delays.
Efficiency: Dedicated teams who understand the client’s processes can deliver documents faster and with fewer revisions.
Integration with Internal Teams: Bespoke services often include working directly with internal teams, streamlining communication and feedback.
Secondary Research in Life Sciences and Healthcare
In the highly regulated environment of life sciences, secondary research plays a vital role in supporting medical writing. It involves gathering and analysing pre-existing data from credible sources such as scientific journals, clinical databases, public health records, and regulatory guidelines.
Secondary research supports medical writing in the following ways:
Data Verification: Ensures that all claims and interpretations are supported by evidence from reliable sources.
Literature Review: Helps writers contextualise study results, therapeutic trends, and clinical implications.
Regulatory Insight: Keeps documents aligned with the latest global submission standards and scientific best practices.
Comparative Analysis: Enables benchmarking of clinical outcomes, drugs, or devices against industry standards.
By integrating secondary research with medical writing, companies can produce high-quality, data-driven documents that stand up to regulatory scrutiny.
How Ascentrik Research Delivers Bespoke Medical Writing Excellence
At Ascentrik Research, we go beyond standard outsourcing models. Our medical writing services are built on the foundation of custom research, full-time expertise, and quality assurance.
1. A Custom Research Approach
Unlike generic service providers who depend on pre-sourced databases, Ascentrik builds every project from the ground up. We gather, validate, and structure data to fit the client’s specific research and writing requirements. This ensures that every document we deliver — from clinical study reports to white papers — is based on fresh, accurate, and verifiable information.
2. Experienced Full-Time Specialists
Our in-house team includes experienced medical writers, scientific researchers, and verification specialists. Because they are full-time employees, not freelancers, they maintain consistent quality, confidentiality, and process familiarity across projects. This continuity is especially important for long-term documentation initiatives such as pharmacovigilance reports, clinical trial submissions, and post-marketing safety updates.
3. Complete Document Lifecycle Support
We assist clients through every phase — from pre-clinical documentation and protocol development to publication support. Our medical writing portfolio includes:
Clinical study reports and summaries
Investigator brochures and informed consent forms
Common Technical Documents (CTDs)
Scientific manuscripts and review articles
Continuing Medical Education (CME) materials
Marketing literature and digital medical communication content
4. Built-In Quality Review and Verification
Each document undergoes rigorous internal checks. Our review services include source data verification, technical editing, copy review, and regulatory formatting. This layered quality-control process ensures compliance and readability.
5. Collaborative and Scalable Engagement
Bespoke writing at Ascentrik also means flexibility. We can manage independent projects end-to-end or integrate directly with the client’s internal teams. This transparent, collaborative model reduces turnaround time, improves document accuracy, and simplifies knowledge transfer.
For global clients who deal with multiple therapeutic areas or regions, Ascentrik’s scalable workforce can act as an extension of their writing or regulatory departments — maintaining alignment with internal documentation standards across all deliverables.
Why Bespoke Medical Writing Matters in Today’s Regulatory Environment
Increasingly stringent submission requirements from organisations such as the FDA, EMA, and CDSCO (India) have expanded the documentation workload for pharmaceutical and biotech firms. Every product approval requires hundreds of regulatory documents, each with precise formatting and language requirements.
Moreover, global clinical trials now demand multilingual communication materials, patient-support documentation, and post-approval safety updates. Under these conditions, generic writing support is insufficient. Bespoke services adapt dynamically to variations in therapy area, regional norms, and organisational style guides.
Ascentrik’s team understands these challenges and customises documentation not just for compliance, but also for clarity and scientific impact.
Integrating Secondary Research and Writing for Maximum Value
By combining secondary data analysis with bespoke writing, Ascentrik creates a powerful advantage for clients. Our writers do not merely reformat data — they interpret it in context, drawing insights that enhance scientific communication and decision-making.
Through detailed literature analysis, competitive intelligence, and data verification, we ensure that all communications are accurate, current, and aligned with clinical and regulatory trends. This integration reduces the revision cycle, saves submission time, and enhances the credibility of every document.
The Future of Medical Writing: Customisation and Hybrid Expertise
As artificial intelligence becomes more capable and regulatory frameworks grow stricter, the future of medical writing lies in hybrid expertise. AI will streamline drafting and review, while human experts will focus on interpretation, narrative development, and compliance validation.
In this emerging landscape, bespoke service providers like Ascentrik will play a central role — offering clients the dual advantage of efficiency and precision. By leveraging technology without compromising on human expertise, we ensure that every output meets the highest scientific, ethical, and quality benchmarks.
Conclusion
Medical writing has evolved from a support function into a strategic pillar of drug development and regulatory communication. With rising documentation needs, global compliance pressures, and an expanding landscape of clinical data, the importance of bespoke medical writing cannot be overstated.
Ascentrik Research bridges the gap between science and communication through a custom research-driven methodology. Our full-time team of experts ensures that every document — whether regulatory, educational, or scientific — is accurate, reliable, and compliant.
For organisations in the life sciences and healthcare ecosystem, partnering with Ascentrik means gaining not just a writing team but a knowledge ally — one that delivers clarity, compliance, and confidence in every submission and publication.
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